One Treatment, Multiple Targets: Prism Adaptation and Left Brain Stroke Rehabilitation
Phase: NA
Conditions: Aphasia, Spatial Neglect, Stroke
Sponsor: VA Office of Research and Development

Prism AdaptaƟon in LeŌ Brain Stroke 
NCT04387162 
10/20/22 

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PROTOCOL TITLE:   Prism Adaptation and Left Brain Stroke Rehabilitation. 
 
PRINCIPAL INVESTIGATOR: 
Amy Rodriguez, PhD 
Center for Visual and Neurocognitive Rehabilitation, Atlanta VA Health Care System 
404-321-6111 x204201 
amy.rodriguez@emory.edu 
 
EXTERNAL (NON-EMORY) COLLABORATORS N/A ☐:                                                                        
N/A  
VERSION:  10/20/22. 
 
FUNDING SOURCE: Department of Veterans Affairs . 
 
 
REVISION HISTORY 
 
Revision # 
Version 
Date 
Summary of Changes 
1 
08/28/20 
Virtual consent and assessment 
2 
03/14/21 
Option to enroll in Registry 
3 
06/15/21 
Time post-onset > 1 month 
4 
10/5/21 
Recording- VA-approved devices, VA-approved servers 
5 
10/25/21 
Transfer from VA approved devices to VA-approved 
servers using VA-issued USB device. 
6 
02/04/22 
Data sharing with other Rodriguez study 
7 
07/05/22 
Updated distribution of recruitment materials 
8 
10/20/22 
Permission to use text messaging to communicate with 
consenting participants 
 
 
 

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Table of Contents 
 
1.0 
Study Summary .................................................................................................................... 3 
2.0 
Objectives............................................................................................................................. 3 
3.0 
Background .......................................................................................................................... 4 
4.0 
Study Endpoints * ................................................................................................................ 9 
5.0 
Study Intervention/Investigational Agent ......................................................................... 10 
6.0 
Procedures Involved* ........................................................................................................ 10 
7.0 
Data and Specimen Banking* N/A ☐ ................................................................................. 11 
8.0 
Sharing of Results with Participants* ................................................................................ 12 
9.0 
Study Timelines* ................................................................................................................ 12 
10.0 Inclusion and Exclusion Criteria* ....................................................................................... 12 
11.0 Vulnerable Populations* N/A ☐ ........................................................................................ 12 
12.0 Local Number of Participants............................................................................................. 12 
13.0 Recruitment Methods ........................................................................................................ 13 
14.0 Withdrawal of Participants* .............................................................................................. 14 
15.0 Risks to Participants* ......................................................................................................... 14 
16.0 Potential Benefits to Participants* .................................................................................... 14 
17.0 Data Management* and Confidentiality ........................................................................... 15 
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants* ............................. 15 
19.0 Provisions to Protect the Privacy Interests of Participants ............................................... 15 
20.0 Economic Burden to Participants ...................................................................................... 16 
21.0 Consent Process ................................................................................................................. 16 
22.0 Process to Document Consent in Writing .......................................................................... 17 
23.0 Setting ................................................................................................................................ 17 
24.0 Resources Available ........................................................................................................... 17 
25.0 Multi-Site Research when Emory is the Lead Site*N/A ☐ ................................................ 18 
26.0 References ......................................................................................................................... 18 
 
 
 
 
 

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1.0 
Study Summary 
 
Study Title 
Prism Adaptation in Left Brain Stroke Rehabilitation 
Study Design 
Multiple baseline, delayed treatment approach 
Primary Objective 
To demonstrate the feasibility of adapted methods for 
assessing and treating spatial and motor function and 
pain in patients with aphasia and memory 
impairment.  
Secondary Objective(s) 
To demonstrate the feasibility of using information 
about lesion location from the radiology report to 
classify frontal vs. nonfrontal lesions 
Research 
Intervention(s)/Interactions 
Prism Adaptation Treatment (PAT) for spatial neglect 
in patients with aphasia and memory impairment 
Study Population 
Left brain stroke patients with aphasia and memory 
impairment 
Sample Size 
30 
Study Duration for 
individual participants 
7 weeks 
Study Specific 
Abbreviations/ Definitions  
DVPRS: Defense and Veterans Pain Rating Scale 
KF-NAP: Kessler Foundation- Neglect Assessment 
Protocol  
PAT: Prism Adaptation Treatment 
WMFT: Wolf Motor Function Test 
Funding Source (if any) 
Department of Veterans Affairs 
 
2.0 
Objectives 
2.1 
Specific Aim 1: To demonstrate the feasibility of adapted PAT procedures 
in patients with aphasia and memory impairment. Hypothesis: Adapted methods 
for PAT administration in patients with aphasia are feasible. Even in the presence 
of memory disorder detecting a treatment signal is possible.  
Specific Aim 2: To demonstrate the feasibility of adapted methods for 
assessing spatial and motor function and pain in patients with aphasia and 
memory impairment. Hypothesis: Adapted methods for assessing spatial and 
motor function and pain in patients with aphasia and memory impairment are 
feasible. 
Specific Aim 3: To demonstrate the feasibility of using information about 
lesion location from the radiology report to classify frontal vs. nonfrontal lesions. 
Hypothesis: Lesion classification results from radiology reports and brain 
mapping methods are consistent, confirming this adaptation provides a clinically 

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accessible, reliable way to identify brain-based predictors of optimal PAT 
response in future studies. 
2.2 
Specific Aim 1: Adapted methods for PAT administration in patients with 
aphasia are feasible. Even in the presence of memory disorder detecting a 
treatment signal is possible.  
Specific Aim 2: Adapted methods for assessing spatial and motor function 
and pain in patients with aphasia and memory impairment are feasible. 
Specific Aim 3: Lesion classification results from radiology reports and brain 
mapping methods are consistent, confirming this adaptation provides a clinically 
accessible, reliable way to identify brain-based predictors of optimal PAT 
response in future studies. 
 
3.0 
Background 
3.1 
Every year about 15,000 Veterans are hospitalized for stroke (Cowper, 
2004). Given the expected rapid and significant increase in Veterans above age 
65 over the next decade (NCVAS, 2011) and the reality that the risk of stroke 
more than doubles each decade after age 55 (CDC, 2010), our aging Veterans are 
at an ever-increasing risk of joining the 80,000 Veterans who are already 
suffering from stroke-related long-term disability (Jia et al., 2006). Stroke and its 
complications represent the most frequent cause of adult-onset disability in the 
US, and post-acute stroke care is among the fastest-growing federal expense 
categories (CDC, 2003; Buntin et al., 2010). Currently, there are separate and 
modality-specific treatment pathways for cognitive and motor impairments, and 
pain, in stroke survivors. Clinicians can access guidelines for evidence-based 
practice from the American Heart Association (Winstein et al. 2016), Veterans 
Administration/Department of Defense (Management of Stroke Rehabilitation 
Working Group 2010) and individual professional organizations such as the 
American Occupational Therapy Association (Wolf and Nilsen 2015). However, 
current guidelines and care pathways still match single conditions to single 
methods of rehabilitation. 
Because of the limited rehabilitation resources available to address 
Veteran functional disability after stroke, we need to identify feasible treatments 
acting on more than one recovery target. Multi-target therapies could also 
improve rates of diagnosis for hidden disabilities, such as spatial neglect and 
pain, which are under-identified, and under-treated (Edwards et al. 2006; Chen 
et al. 2013; Widar and Ahlstrom 2002). Because the care system does not yet 
emphasize multi-target treatments, stroke survivors can experience a 
fragmented interprofessional care process, in which treatment of some disabling 
conditions, but not others, leads to incomplete recovery and reductions in 
quality of life (Haynes et al. 2015).  Lack of care efficiency can also increase care 
costs, prolong hospital stays, and increase utilization of other healthcare services 

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(Olson et al. 2013). Combining interventions for cognitive and motor 
impairments, and pain, and systematically tracking treatment effects would help 
streamline the process for >50% of Veteran stroke survivors who have both 
visible and hidden disabilities (Mahon et al. 2017; Yelnik et al. 2011; 
Management of Stroke Rehabilitation Working Group 2010), and help ensure 
that they receive optimal services during the post-acute period. By establishing 
the feasibility of applying standardized methods for assessment, treatment and 
prediction of treatment response in patients with left brain stroke, we contribute 
to two broad goals of this line of research. 
GOAL 1: To develop clinically translatable, multi-target treatments for broad 
application in stroke. 
Prism adaptation treatment (PAT; Barrett, Goedert, and Basso 2012) is a 10-day 
spatial retraining treatment regimen developed to treat the disabling post-stroke 
visual-cognitive disorder, spatial neglect (Barrett and Houston 2019; Heilman, 
Watson, and Valenstein 2012; Corbetta and Shulman 2011; Hillis, Mordkoff, and 
Caramazza 1999). Although many studies demonstrated the benefit of using PAT 
to treat spatial neglect (see Yang et al., 2013 for review), studies have also 
demonstrated positive effects on motor function (see Champod et al., 2016) and 
on pain. Direct measurement of functional movements in the laboratory 
supported a beneficial effect of PAT on arm movements, center of gravity, and 
posture (Fortis et al. 2011; Shiraishi et al. 2008; Nijboer et al. 2014). In addition, 
case series data indicate that PAT can be used as a non-pharmacologic treatment 
to reduce post-stroke pain (Sumitani et al. 2007; Christophe et al. 2016), which 
occurs in about half of stroke survivors, (Naess, Lunde, and Brogger 2012; 
Lundstrom et al. 2009; Hansen et al. 2012) adversely affecting cognitive and 
functional independence, and quality of life (Harrison and Field 2015). As we 
note above, PAT was developed for spatial retraining.  Because spatial function 
and other cognitive processes are potentially distributed and highly interactive 
with other functional domains, spatial retraining may provide a “back door” to 
improve motor recovery and somatic experience through pain relief. Given the 
high rates at which stroke patients experience spatial-motor-sensory 
impairments, and in the absence of integrated treatment plans that encompass 
the three domains depicted in Figure 1, a multi-target treatment such as PAT is 
highly desirable. Although available controlled trials of PAT and other spatial 
neglect treatments indicated that these therapies can restore adaptive 
movements and functional abilities, studies have been conducted exclusively in 
people with right brain stroke (Yang et al. 2013). Clinicians are unlikely to 
administer PAT routinely for stroke survivors when there is no evidence that 
doing so will yield therapeutic benefit in left brain stroke. Additionally, clinicians 
may hesitate to apply PAT in patients with aphasia and memory impairments, 
which are common after left brain stroke (Pedersen et al., 1995; Eskes & Barrett 
2009). Thus, we identified the potential for a high-risk, high-reward study that 
demonstrates feasibility of standardized assessment and treatment methods in 

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left brain stroke patients, to open a path for broad application of PAT in both left 
and right brain stroke survivors.  
GOAL 2: To develop clinically translatable assessment methods for diagnosis and 
identification of subgroups who will benefit from multi-target treatments.  
Patient-centered, precision medicine is tailored to brain-based factors relevant 
to recovery in an individual stroke survivor. Genetic risk factors are often 
considered in predictors of stroke recovery (Cramer, 2008). Cognitive deficits 
also predict response to rehabilitation (Dignam et al., 2017), possibly because 
they interact with motor brain systems (Barrett, Boukrina, and Saleh 2019) or 
alter the applicability of global outcome measures (Bosetti et al., 2017; Cramer, 
2007). The potential impact of cognitive deficits on rehabilitation outcomes 
highlights the need for comprehensive and accurate diagnosis to guide clinical 
decision-making. 
 
In addition, brain physiology and anatomy may also define patient subgroups 
with better response to specific rehabilitation methods (e.g. non-invasive brain 
stimulation; Plow et al., 2016; Nouri & Cramer, 2011). Although patients across a 
range of brain lesion locations may experience treatment benefit from PAT (see 
Yang et al., 2013 for a review), we and others reported that the presence of 
frontal lobe cortical lesions predicts optimal response to treatment, and 
subsequent recovery of functional performance in stroke-induced spatial neglect 
(Chen et al., 2014; Goedert et al., 2018; Gutierrez-Herrera et al., 2018). These 
experiments were carried out exclusively in right brain stroke-- no data about 
brain-behavior relationships in recovery from neglect after left brain stroke, with 
or without treatment, is available. To develop PAT in future large-scale studies as 
a multi-target treatment for use in patients with both left brain stroke and right 
brain stroke, first requires determining whether stratifying patients by frontal 
lobe lesions reveals differences in treatment benefit. The presence of large 
differences in PAT response related to lesion location would affect the design 
and evaluation of PAT for stroke rehabilitation as well as eventual clinical 
decision-making for assigning PAT to eligible stroke survivors. However, clinicians 
in rehabilitation settings typically obtain information about lesion location from 
a patient’s medical record. Before guidelines for PAT patient selection can be 
broadly implemented, we must establish that obtaining information about lesion 
location from the radiology report, as compared to research-based brain 
mapping methods, is a feasible and reliable method of categorizing lesions.   
3.2 
Preliminary Study 1: Members of our team have demonstrated that 
administration of PAT using standardized methods is feasible and yields 
therapeutic benefits in right brain stroke (Barrett et al. 2012). Purpose: Expert 
clinicians who assess and treat invisible disabilities like spatial neglect use a 
variety of rehabilitation techniques (Chen et al. 2017) depending on barriers 
present, recovery stage, and characteristics of the deficit. However, clinicians 
carrying out routine care find a large number of choices for spatial neglect 

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treatment confusing and impractical. Methods:  Of all of the treatments 
available, prism adaptation treatment (PAT) was identified as being the most 
feasible (Barrett, Goedert, & Basso 2012). PAT improved spatial neglect in 
multiple randomized studies (Yang et al. 2013), and is also time-efficient, 
requiring only 10, short, daily sessions (20-30 minutes), with no components of 
treatment that need to be cross-implemented, carried out during other times of 
day, or co-administered as part of other therapies (Barrett & Houston 2019). PAT 
was manualized, and in a network of inpatient rehabilitation sites that received 
training, the time for therapists to learn how to administer PAT is less than a day. 
Results:  PAT improves daily life function (Champod et al. 2016), and 
improvements are noted in self-care, reading and writing, and even wheelchair 
navigation and posture. Conclusions: Standardizing the administration of PAT 
allowed for packaging the care process for training of more than 100 therapists 
in a nationwide practice-based network to deliver right brain rehabilitation 
(Barrett, 2019). This study will extend this work by establishing the feasibility of 
adapted PAT procedures in left brain stroke patients with aphasia and memory 
impairment (Aim 1). 
Preliminary Study 2: Members of our team have standardized methods for 
assessment of spatial neglect in right brain stroke (Chen et al. 2012; Chen et al. 
2015). Purpose:  In 60-80% of people with spatial neglect, care professionals do 
not diagnose or document the disorder during routine inpatient rehabilitation 
(Chen et al. 2013; Edwards et al. 2006). Because it has an independent, adverse 
effect on multiple domains of daily life function, assessing spatial neglect via 
functional performance is the first step to assigning treatment and speeding 
neurological recovery. Methods: The semi-quantitative, examiner-rated 
Catherine Bergego Scale (CBS), which is a reliable, validated 10-item 
questionnaire to detect and evaluate spatial neglect severity (Azouvi 2016; Chen 
et al. 2015; Azouvi et al. 2003) was adapted. The Kessler Foundation Neglect 
Assessment Process (KF-NAP®), a manualized process was added which provides 
detailed instructions and specifies that administration takes place by one 
examiner during a single assessment session (Chen et al. 2012; Chen, Chen, et al. 
2015). Results:  Catherine Bergego Scale via the KF-NAP® is an excellent predictor 
of rehabilitation outcomes (Chen et al. 2015) and its simplicity is appealing to 
clinicians, who report its adoption in 13 countries, and more than 40 US 
inpatient and outpatient care settings. Conclusions:  The KF-NAP® is a 
systematic, evidence-based valid method of spatial neglect assessment after 
right brain stroke. This study will extend this work by establishing the feasibility 
of adapted KF-NAP® procedures for assessing spatial neglect in left brain stroke 
patients with aphasia and memory impairment (Aim 2). 
Preliminary Study 3: Members of our team have developed standardized 
methods for assessment of motor function in stroke patients without cognitive 
impairment (Wolf et al., 2001). Purpose: Greater than 70% of stroke patients 
suffer motor impairments (Mohr et al., 1993), making assessment and treatment 

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of motor function a high priority in stroke rehabilitation. The Wolf Motor 
Function Test (WMFT) is a time-based assessment that quantifies functional 
ability of upper extremities through a series of tasks ranging in complexity and 
proximal to distal involvement. WMFT requires few tools and minimal training 
for administration, making it ideal for clinical use. Methods: Healthy older adults 
and patients with chronic stroke were administered the WMFT and the upper 
extremity portion of the Fugl-Meyer Motor Assessment (FMA) at two time points 
12-16 days apart. Results: The WMFT and FMA demonstrated agreement 
between raters at both time points. WMFT scores for upper extremities of 
healthy older adults were significantly different from than those of the stroke 
patients. The WMFT and FMA scores for the more affected extremity in stroke 
patients were related. Conclusions:  The WMFT is a valid and reliable assessment 
of motor function in stroke patients without cognitive impairment. This study 
will extend this work by establishing the feasibility of adapted WMFT procedures 
for assessing motor function in left brain stroke patients with aphasia and 
memory impairment (Aim 2).  
Preliminary Study 4: Using brain mapping methods, members of our team have 
shown that right brain stroke patients with frontal lesions respond optimally to 
PAT (Chen et al., 2014; Goedert et al., 2018). Purpose:  Research with 
neurologically unimpaired individuals suggests that prism adaptation may 
stimulate lateralized motor-related spatial systems (Fortis, Goedert, and Barrett 
2011) linked to frontal cortical brain networks (Ghacibeh et al. 2007). Thus, the 
presence or absence of frontal brain lesions may affect PAT response. Methods: 
We had trained raters categorize patients based on their clinical brain images: as 
having, or not having, a frontal cortical brain lesion (Chen et al. 2014; Goedert et 
al. 2018). Results:  In both studies, patients with frontal brain lesions 
experienced a more robust therapeutic response to PAT, based on functional 
performance testing. Although in the first study, medial temporal structures also 
appeared to play a role in PAT response, this was not confirmed in the second 
study. Conclusions: A frontal cortical lesion predicts optimal PAT response after 
right stroke. However, clinical decision-making based on brain mapping with 
trained raters is not feasible in the clinical environment. This study will extend 
this work by determining whether obtaining information about lesion location 
from the medical record is a feasible, reliable way to identify patients with 
frontal vs. nonfrontal lesions (Aim 3). 
3.3 
This study is the first to systematically investigate the feasibility of using 
adapted PAT treatment procedures and spatial-motor-sensory assessments in 
left-brain stroke patients with aphasia and memory impairment, as well as 
clinically-accessible methods for identifying patients with optimal response to 
PAT. This line of research lays the foundation for a potential paradigm shift in the 
focus of rehabilitation research to PAT as a multi-target treatment to improve 
spatial function, adaptive movements, functional independence, and pain-free 
somatic experience. In addition, this study could change the conventional 

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structure of stroke rehabilitation trials, most of which have not measured the 
impact of cognitive treatments on motor function, or vice versa, and do not 
assess the concurrent effect of either cognitive or motor treatment on pain. 
4.0 
Study Endpoints * 
4.1 
We will assess four key aspects of feasibility of our adapted assessment 
and treatment procedures: acceptability, implementation, adaptation, and 
limited efficacy testing (Bowen et al., 2009). See Table 1.  Acceptability: We will 
use the Client Satisfaction Questionnaire (CSQ-8; Attkinson & Zwick, 1982; 
Larsen et al., 1979) to assess satisfaction and perceived value of PAT. We will use 
the Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000) to 
assess the degree to which PAT is believable, convincing and logical (credibility) 
and the expectations for PAT-induced improvement (expectancy). The CSQ-8 and 
CEQ have been used in patients with subjective cognitive impairment (Foster et 
al., 2018). Implementation: We will record attendance and completion rates to 
determine whether KF-NAP®, WMFT and PAT can be carried out as planned. 
Adaptation: Each session, study staff will complete checklists from the KF-NAP®, 
the WMFT, and the KF-PAT™ manual (Chen, 2015) to track assessment and 
treatment fidelity. Notations will be made when modifications to administration 
methods are required. For the brain mapping, trained raters will map brain 
lesions using the method from Preliminary Study 4. Then, a blinded neurologist 
will classify participants as having “frontal” or “nonfrontal” lesions. Using 
radiology reports, lesions will be classified as “frontal” based on use of that word 
or “anterior” “premotor” “prefrontal” or “precentral” or as “nonfrontal” if none 
of those words are present. Limited Efficacy Testing: To detect the acquisition 
and maintenance of a treatment signal, we will assess spatial-motor-sensory and 
functional recovery over 7 weeks (Figure 2). We will assess: 1) Functional 
disability, measured by activities of daily living using the Barthel Index (Mahoney 
& Barthel 1965) and cognitive and motor function with the FIM or FONE-FIM; 2) 
Spatial neglect, measured by the Behavioural Inattention Test-conventional 
subtest (Wilson et al., 1987) and CBS via the KF-NAP® (Chen et al. 2012); 3) 
Motor function, measured by the WMFT (Lin et al., 2009); and 4) Pain, measured 
by the Defense and Veterans Pain Rating Scale (Polomano et al. 2016), which 
includes numbers along with pictures and colors to facilitate nonverbal rating of 
pain. Assessments will be administered by a trained examiner.  
TABLE 1. Study Endpoints. 
 
 
 
 
 
 
 

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4.2 N/A 
5.0 
Study Intervention/Investigational Agent 
5.1 
PAT will be administered 5 days per week for 2 weeks (10 sessions) using a 
portable kit with manual (KF-PAT®; Chen 2015) by a trained study clinician. This spatial 
retraining approach involves repeated arm movements to visual targets while wearing 
goggles that shift the visual field horizontally. To treat right‐sided neglect, yoked, 20-
diopter, right‐based wedge lenses (in which the right side is thicker) are used. The 
prismatic distortion causes the visual illusion that objects in the environment are 
displaced to the left.  Thus, reaching movements with the prisms on are shifted to the 
left of a fixed target. Over repeated attempts to interact manually with the target 
through visual-motor practice, spatial processing leads to motor adaptation, and the 
participant correctly reaches for the target. After removing the prisms, visual 
information returns to normal, but the spatial-motor system has increased its 
propensity to move rightward (Fortis et al., 2011). Thus, when the goggles are removed, 
the participant will reach for a fixed target and miss by making a movement that is 
directed too far rightward. The Nausea Profile, found on page 15 of the treatment 
manual, will be administered the first three days of treatment per recommendations. 
5.2 
N/A 
5.3 
N/A 
6.0 
Procedures Involved* 
6.1 
 This 7-week prospective study uses a multiple baseline, delayed 
treatment approach to address four key areas of focus for feasibility studies 
(Bowen et al., 2009). Participants will be assigned to one of two groups using 

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computer-generated pre-assignment. Group 1 will begin PAT after two baseline 
sessions. Group 2 will begin PAT after four baseline sessions.  
 
6.2 
Participants will undergo baseline memory and language assessments, 
along with weekly assessments of functional ability, spatial and motor function, 
and pain from baseline through 7 weeks. Treatment will be provided 5 days per 
week for two weeks following a two- or four-week baseline. Assessment and 
treatment procedures may be conducted face-to-face or by VA-approved audio 
(phone) or video communication to decrease the amount of face-to-face 
interaction at the Atlanta VA. Assessment and treatment procedures may be 
audio and/or video recorded for research purposes. The recordings will be 
acquired on VA-approved devices. The patients will be informed of the audio or 
video recording. The recordings will be stored on VA approved servers. 
6.3 
Risks and procedures to minimize risks are outlined in section 15.0. The 
source records that will be used to collect data are provided in the IRB smart 
form and include: Visual Analog Mood Scales (Arruda et al. 1999), the McGill 
Pain Questionnaire (Melzack 1987), the Michigan Body Map (Brummett et al. 
2016), Trail Making Test (Delis, Kaplan & Kramer, 2001), Functional 
Independence Measure (FIM; Granger et al. 1993) or telephone-administered 
(FONE-FIM; Chang, Slaughter, et al. 1997; Chang, Chan, et al. 1997), Western 
Aphasia Battery (Kertesz, 1982), Brief Visuospatial Memory Test- Revised 
(Benedict et al. 1996), Hopkins Verbal Learning Test- Revised (Benedict et al. 
1998), and digit span forward and backward (Lezak et al., 2004), as well as the 
CSQ-8, CEQ, KF-NAP®, WMFT (described above in section 4.0) and Nausea 
Profile.  
6.4 
Data will be obtained through the medical record, assessments of 
language, memory, spatial, and physical function, pain, and functional ability as 
described above. 
6.5 N/A  
6.6 N/A 
7.0 
Data and Specimen Banking* N/A ☐ 

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N/A 
8.0 
Sharing of Results with Participants* 
8.1 
Study-related assessment and treatment results may be shared with 
participants upon request, without clinical interpretation.  
8.2 
N/A 
8.3 
N/A 
8.4 
N/A 
9.0 
Study Timelines* 
9.1 
Participants will complete the study in approximately 7 weeks. We 
anticipate an active recruitment period of 1.5 years with all study procedures 
completed by end of 2023.  
10.0 Inclusion and Exclusion Criteria* 
10.1 
Individuals who indicate interest in participating will undergo a brief 
phone screen to determine if they meet the initial eligibility criteria. Contact will 
be via telephone to prevent unnecessary burden of traveling to the Atlanta VA if 
the individual does not qualify for the study. Subjects will be informed of the 
nature of the study and procedures and their right not to participate. 
10.2 
Inclusion criteria:  Participants will be: 1) 18-89 years of age; 2) >1 month 
post-stroke; 3) proficient English speakers; 4) of moderate functional disability 
(17-67 scored on Functional Independence Measure, observational (Granger et 
al. 1993) or telephone-administered (FONE-FIM; Chang, Slaughter, et al. 1997; 
Chang, Chan, et al. 1997) as indicated by published ranges (Chumney et al. 
2010); 5) experiencing aphasia as determined by a Western Aphasia Battery 
Aphasia Quotient of <93.7 (Kertesz, 1982) and memory impairment as 
determined by a score that is >1.5 standard deviations below the norm on the 
Brief Visuospatial Memory Test- Revised (Benedict et al. 1996), the Hopkins 
Verbal Learning Test- Revised (Benedict et al. 1998) or digit span forward and 
backward (Lezak et al., 2004); and 6) able to provide informed consent to 
participate, using aphasia-accessible process, as needed.  
Exclusion criteria: History of brain conditions other than left brain stroke, 
including clinical right brain pathology.  
10.3 N/A 
10.4 N/A 
11.0 Vulnerable Populations* N/A ☐ 
11.1 N/A  
12.0 Local Number of Participants 

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12.1 30 
12.2 
Based on attrition rates in our previous studies, we expect ~20% of 
participants will not complete the study. Thus, we will need to enroll 
approximately 36 participants to achieve the target sample size of 30. We 
anticipate needing to screen approximately 100 patients in order to meet our 
target sample size.  
13.0 Recruitment Methods 
13.1 
This study will target United States Veterans. Non-VA patients maybe 
enrolled to maximize the number of women in the study as historically difficult 
to enroll enough women. Our primary recruiting sources will be the VA Clinical 
Case Registry (CCR) using selected ICD-9 and ICD-10 codes. Potential Veteran 
participants will be mailed an IRB approved recruitment letter, as well as an opt 
in/opt out response form to be returned using a postage paid envelope. This will 
allow for potential subjects to indicate whether they would like to be contacted 
in the future related to the study. If no response is received within two weeks, 
we will follow up with a phone call to gauge subject interest. The potential 
participants that do not meet the screening criteria for this study will be offered 
the option to enroll in the Atlanta VA Rehab R&D CVNR Participant Registry 
(IRB00000159), a secure electronic list of people who wish to be told about the 
research studies at the CVNR. We will also recruit through the CVNR Research 
Registry (IRB#00000159), referrals from VA healthcare providers, and 
advertisements in clinics and closed-circuit television at the Atlanta VA Health 
Care System. As it is estimated that only 20% of Veterans with aphasia receive 
their healthcare within the VA Health Care System (VAntage Point, 2018), Emory 
Healthcare is also an important recruitment source for Veterans. Our 
recruitment network at Emory includes the Emory Stroke Team that includes 
members of the Emory-Georgia Stroke Network and the Marcus Stroke & 
Neuroscience Center at Grady Memorial Hospital, which together serve 
approximately 750 new stroke patients yearly. Recruitment will also be 
supported by community-based advertisement through online and in person 
distribution of approved recruitment materials via professional organizations 
such as the Georgia Speech-Language-Hearing Association (GSHA), the American 
Speech-Language-Hearing Association (ASHA), and Up Close Marketing, Inc. 
13.2 Participants will be recruited from the sources described in 13.1. 
13.3 Methods used to identify potential participants include clinical and 
research registries described in 13.1, referrals from providers, review of 
medical records and study fliers. 
13.4 We will use study fliers to assist with recruitment. 
13.5 Participants will receive $15 per session. Payments will be disbursed at 
completion of the study or at the point of termination or withdrawal. 

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14.0 Withdrawal of Participants* 
14.1 
Participants will be withdrawn from the study if they do not follow study 
procedures or if continuing in the study would be unsafe. 
14.2 
Terminations will be communicated promptly with the participant and 
compensation for completed study visits will be processed. 
14.3 
Data collection will not continue with participants who withdraw from 
the study, but data already collected may be used. 
15.0 Risks to Participants* 
15.1 
Language and cognitive assessment: Subjects may become worried if 
they fail to meet cognitive screening criteria. This risk is only occasional, and 
effects are manageable by study staff who will be administering the tests. 
Subjects may become frustrated during cognitive and language tests. This risk is 
only occasional and effects are manageable by study staff who will be 
administering the tests. Subjects may become fatigued during cognitive and 
language tests. This risk is only occasional and effects are manageable by study 
staff who will be administering the tests. Additionally, we will decrease testing 
burden for participants, when possible. Dr. Rodriguez’s study entitled “Intention 
Treatment for Anomia” (IRB#116056) also investigates stroke and aphasia. While 
the question for this study is different, the framework is in place to use 
assessment data collected in Dr. Rodriguez’s other study to reduce the number 
of assessments in this study. Specifically, we may obtain a participant’s data on 
the Western Aphasia Battery-Revised (WAB-R), Hopkins Verbal Learning Test-
Revised (HVLT-R), Brief Visuospatial Memory Test-Revised (BVMT-R), and Digit 
Span. 
Nausea due to prism adaptation goggles: Some subjects may experience 
nausea while wearing the prism adaptation goggles. This risk is minimal and 
expected to resolve after removal of the goggles. However, per the treatment 
manual, we will administer the Nausea Profile the first three days of treatment 
and discontinue if nausea persists. The nausea profile is found on pg 15 of the 
treatment manual. 
Loss of confidentiality: There is a risk that a subject’s identifiable 
information (PHI, PII) will be inadvertently seen by someone other than study 
personnel who are authorized to access the information. Loss of confidentiality 
can occur during language and cognitive testing. This risk is minimal and will be 
managed by adhering to guidelines set forth to maintain confidentiality.  
15.2 There may be risks to participants that are currently unforeseeable. 
15.3 N/A 
15.4 N/A 
16.0 Potential Benefits to Participants* 

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16.1 
Participants will receive information about their language, memory, 
spatial and physical abilities, functional abilities and pain. 
16.2 There may be no direct benefit to study participation. 
17.0 Data Management* and Confidentiality 
17.1 
Data on four key areas of feasibility will be analyzed using descriptive 
statistics, including measures of frequency, central tendency, dispersion and 
variation. See Table above.  
17.2 
Study staff will complete and stay current on all training regarding data 
security and confidentiality. Written and electronic data will be coded by subject 
number. All written data will be kept in study binders or folders in a locked 
cabinet in the PI’s locked office. Electronic data containing any identifiable 
information (PHI, PII), including audio and video recordings, will be kept in a VA 
protected environment (e.g., VA-approved servers). Audio and video recordings 
obtained on VA-approved devices will be transferred to a VA-approved server 
using a VA-issued USB device. 
17.3 
Checklists will be used to ensure that all study procedures are completed. 
Reliability checks will be completed on data from assessments.  
17.4 
Describe how data or specimens will be handled study-wide: All data will 
be stored on the VA trusted server. Data will be stored in closed systems with 
access only for study team members on VA trusted server. I Identifiable data will 
only be stored for the length of the study plus any unanticipated delay time.  If 
data is retained after this time it will be de-identified. Study team members will 
have access to the data. The PI is ultimately responsible for the receipt of the 
data and storage to the appropriate locations. Data will not be transported as it 
will be stored to the appropriate online storage from its collection point. 
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants* 
N/A 
19.0 Provisions to Protect the Privacy Interests of Participants 
19.1 
Confidentiality will be protected throughout the study and following 
completion of the study.  All study participants will receive a Subject ID which 
will be kept separate from all source documents.  As a guard against risk of 
confidentiality, all information will be stored in locked files in a locked research 
area that can only be accessed by research personnel. No names or identifying 
information will be used in publications that result from this research.  In cases 
where data are laptop, no data containing identifiers or PHI will be stored on 
hard drives—only on removable media, which will be removed from the 
computer when not in use. All databases will be password protected. 
19.2 
Study procedures will be explained to the participant during informed 
consent, and at the beginning of each study visit. Participants will regularly be 

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asked if they have any questions and reminded that that they can opt out of the 
study at any time.  
19.3 
All participant data will be stored on VA Research Server and only 
approved study team members will have access to this data. 
19.4 
Study staff will access data through VA approved networks. 
20.0 Economic Burden to Participants 
20.1 
Participants will pay for the cost of traveling to and from study visits. We 
provide compensation of $15 per visit to help defray these costs. 
21.0 Consent Process 
The informed consent process may be conducted face-to-face or by VA-approved audio 
(phone) or video communication to decrease the amount of face-to-face interaction at 
the Atlanta VA. For face-to-face orientation and consent, the PI/Co-PI or their trained 
study staff will go over and describe the consent in a quiet room. Prior to providing 
written consent, potential subjects will be given the chance to ask questions and the 
PI/Co-PI or study staff will ask questions to ensure the potential subject understands 
what the study entails. For phone or video consenting, we will mail or email through VA 
Outlook using Azure encryption two unsigned copies of the ICF/HIPAA. We will ensure 
the individual has enough time after receiving the document to read it before scheduled 
phone/video call. Trained staff will perform consenting process including speaking with 
the individual to discuss the study and highlighting each section of the consent form, 
allowing the participant an opportunity to ask questions before providing consent, and 
giving the participant enough time to consider being in the study.  Study team will 
inform the individual that if they would like to take more time to consider the study, 
another telephone call can be scheduled.  If the individual would like to participate, the 
participant will sign and date the document and return it to study team via mail (phone) 
or via email to your VA Outlook email address (video). Recordings of the audio or visual 
communication will not be permitted. Study team will write a “Note to File” that 
documents everything about the interaction including:  1. When and how the consent 
form was sent 2. When the video/telephone call was made 3. What was discussed 
during the call 4. When the signed consent form was received 5. When the signed 
consent form was signed by the person obtaining consent 6. When a copy of the 
consent form signed by both subject and study team was given to the participant and 7. 
A description of why signature dates are different (if applicable).  Once the study team 
receives the signed consent form, the person obtaining consent should sign the form 
and date it for the day it was signed. Study procedures will begin once the signed copy is 
received. Text messages may be used by the study team to communicate with subjects 
who have consented to participate. All text messages will be sent using an encrypted, 
VA-issued study iPhone. A copy of the fully signed consent form will be given to the 
participant via mail or in person at next scheduled visit. Prior to any virtual study visits, a 

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technology questionnaire will be completed to determine if the participant will be able 
to complete any study procedures virtually. Please describe: 
Non-English-Speaking Participants N/A ☐ 
N/A 
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves deception) 
N/A 
Participants who are not yet adults (infants, children, teenagers) N/A ☐ 
N/A 
Cognitively Impaired Adults N/A ☐ 
N/A 
Adults Unable to Consent N/A ☐ 
N/A 
22.0 Process to Document Consent in Writing 
22.1 
Participants will provide written informed consent. 
22.2 
N/A 
22.3 
Document for obtaining written consent available in IRB smart form. 
23.0 Setting 
23.1 
All study visits will take place at Center for Visual and Neurocognitive 
Rehabilitation (CVNR), Atlanta VA Health Care System.  The study staff will 
identify and recruit potential participants as outlined in section 13.0. 
24.0 Resources Available 
24.1 
Our primary recruiting sources will be the VA Clinical Case Registry (CCR) using 
selected ICD-9 and ICD-10 codes, CVNR Research Registry (IRB#00000159), referrals 
from VA healthcare providers, and advertisements in clinics and closed-circuit television 
at the Atlanta VA Health Care System. As it is estimated that only 20% of Veterans with 
aphasia receive their healthcare within the VA Health Care System (VAntage Point, 
2018), Emory Healthcare is also an important recruitment source for Veterans. Our 
recruitment network at Emory includes the Emory Stroke Team that includes members 
of the Emory-Georgia Stroke Network and the Marcus Stroke & Neuroscience Center at 
Grady Memorial Hospital, which together serve approximately 750 new stroke patients 

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yearly. Approximately 40% of individuals with left hemisphere stroke present with 
aphasia, and our recruitment target is 30. We anticipate we will need to screen about 
100 people to reach our enrollment target. Screening and enrollment will occur on a 
rolling basis with PI and staff time dedicated to recruitment. Our facility contains quiet 
rooms for obtaining informed consent, as well as administering assessments and 
treatment. Study funds will be used to obtain all necessary materials for completing 
study procedures. The PI and other study staff are trained in all study-related 
procedures and will stay current on mandatory trainings related to human subjects 
research. A signed statement of study roles and responsibilities, along with training 
certificates, will be kept on file. 
25.0 Multi-Site Research when Emory is the Lead Site*N/A ☐  
N/A  
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Statistical Analysis Plan 
 
Data on four key areas of feasibility will be analyzed using descriptive statistics, including measures of 
frequency, central tendency, dispersion and variation. See Table 1.  
Acceptability: We will use the Client Satisfaction Questionnaire (CSQ-8; Attkinson & Zwick, 1982; Larsen et al., 
1979) to assess satisfaction and perceived value of PAT. We will use the Credibility/Expectancy Questionnaire 
(CEQ; Devilly & Borkovec, 2000) to assess the degree to which PAT is believable, convincing and logical 
(credibility) and the expectations for PAT-induced improvement (expectancy). The CSQ-8 and CEQ have been 
used in patients with subjective cognitive impairment (Foster et al., 2018). 
Implementation: We will record attendance and completion rates to determine whether KF-NAP®, WMFT and 
PAT can be carried out as planned. 
Adaptation: Each session, study staff will complete checklists from the KF-NAP®, the WMFT, and the KF-
PAT™ manual (Chen, 2015) to track assessment and treatment fidelity. Notations will be made when 
modifications to administration methods are required. For the brain mapping, trained raters will map brain 
lesions using the method from Preliminary Study 4. Then, a blinded neurologist will classify participants as 
having “frontal” or “nonfrontal” lesions. Using radiology reports, lesions will be classified as “frontal” based on 
use of that word or “anterior” “premotor” “prefrontal” or “precentral” or as “nonfrontal” if none of those words are 
present.  
Limited Efficacy Testing: To detect the presence of a treatment signal, we will assess spatial-motor-sensory 
and functional recovery over 7 weeks. We will assess: 1) Functional disability, measured by activities of daily 
living using the Barthel Index ((Mahoney and Barthel 1965) and cognitive and motor function with the FIM or 
FONE-FIM; 2) Spatial neglect, measured by the Behavioural Inattention Test-conventional subtest ((Wilson, 
Cockburn, and Halligan 1987) and CBS via the KF-NAP® (Chen et al. 2012); 3) Motor function, measured by 
the WMFT (Lin et al., 2009); and 4) Pain, measured by the Defense and Veterans Pain Rating Scale 
((Polomano et al. 2016), which includes numbers along with pictures and colors to facilitate nonverbal rating of 
pain. Assessments will be administered by a trained examiner. 
Key Area 
Question 
Analysis on Outcome of Interest 
Acceptability 
• Do left brain stroke patients view PAT 
as a satisfactory and credible tool for 
rehabilitation? 
• Range of post-PAT satisfaction ratings 
on CSQ-8 
• Range of credibility and expectancy 
ratings on CEQ  
Implementation • Can KF-NAP®, WMFT, DVPRS and 
PAT be implemented as planned in 
left brain stroke patients? 
• Completion rate for KF-NAP®, WMFT, 
DVPRS and full 10-session PAT 
Adaptation 
• What modifications are necessary for 
implementation of KF-NAP®, WMFT 
and PAT in left brain stroke patients? 
• Is classification of lesion location from 
the medical record consistent with 
classification using brain mapping? 
• Number and type of modifications to 
KF-NAP®, WMFT and PAT protocol 
• Percent agreement on presence or 
absence of frontal lesion between 
radiology report and brain mapping 
Limited Efficacy 
Testing  
• Is there promise for application of 
PAT in left brain stroke patients? 
• Spatial-motor-sensory and functional 
assessments over 7 weeks to detect 
presence of a treatment signal 
     Table 1. Key areas of feasibility and related data analysis.