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SUMMARY STATEMENT 

PROGRAM CONTACT: ( Privileged Communication ) Release Date: 10/26/2018 

Revised Date: 

Application Number: 1 R01 DC017174-01A1 

Principal Investigators (Listed Alphabetically): 

CHERNEY, LEORA R 

HEINEMANN, ALLEN WALTER (Contact) 

Applicant Organization: REHABILITATION INSTITUTE OF CHICAGO 

Review Group: LCOM 

Language and Communication Study Section 

Meeting Date: 10/18/2018 RFAIPA: PA18-287 

Council: JAN 2019 PCC: VS01 

Requested Start: 04/01/2019 

Project Title: Defining Trajectories of Linguistic, Cognitive-Communicative and Quality of Life 

Outcomes in Aphasia 

SRG Action: Impact Score:17 Percentile:5 

Next Steps: Visit https://grants.nih.gov/grants/next_steps.htm 

Human Subjects: 30-Human subjects involved - Certified, no SRG concerns 

Animal Subjects: 10-No live vertebrate animals involved for competing appl. 

Gender: 1A-Both genders, scientifically acceptable 

Minority: 1A-Minorities and non-minorities, scientifically acceptable 

Children: 3A-No children included, scientifically acceptable 

Project Estimated 

Year Total Cost 

1 

2 

3 

4 

5 

TOTAL 

ADMINISTRATIVE BUDGET NOTE: The budget shown is the requested budget and has not been adjusted 

to reflect any recommendations made by reviewers. If an award is planned, the costs will be calculated by 

Institute grants management staff based on the recommendations outlined below in the COMMITTEE 

BUDGET RECOMMENDATIONS section. 
 

 

 

 

 

 

 

 

 

 

 

 

 

1 R01 DC017174-01A1 2 LCOM 

HEINEMANN, A 

1R01DC017174-01A1 Heinemann, Allen 

RESUME AND SUMMARY OF DISCUSSION: This application proposes a project to investigate and 

model linguistic, cognitive-communicative, and quality of life (QoL) outcome trajectories in people with 

aphasia following a stroke. This large, innovative project addresses a critical barrier to prognosis and 

treatment and if successful would be paradigm shifting in approaches to aphasia recovery. The 

investigative team and environment are outstanding. The approach is rigorous, with the inclusion of 

genotype and a highly sophisticated data analysis plan noted as particular strengths. The panel noted 

only minor weaknesses, including that the application is only partially responsive to prior concerns 

about how the project will handle the large amount of data, and that there is a potential for bias in the 

sample. Overall, this project addresses a highly significant research area and is likely to exert a large, 

sustained impact on the treatment of aphasia. 

DESCRIPTION (provided by applicant): Stroke imposes significant burdens on the health and quality 

of life of survivors and their caregivers, and presents a major public health issue in terms of healthcare 

costs and lost productivity. Aphasia adds to the cost of stroke-related care. Many stroke survivors with 

aphasia receive therapy in inpatient rehabilitation facilities. However, aphasia recovery is variable and 

there is limited evidence on the benefits of inpatient rehabilitation on outcomes. The objective of this 

study is to describe the trajectories of linguistic, cognitive-communicative, and health-related quality of 

life (QoL) outcomes following stroke in persons with aphasia during inpatient and outpatient 

rehabilitation to 18 months following stroke. A sample of 300 consecutively-admitted stroke patients 

with aphasia recruited at three Midwestern rehabilitation hospitals will complete measures of linguistic 

and cognitive-communicative performance, and the Quality of Life in Neurological Disorders (NeuroQoL) Measurement System instruments during rehabilitation and at 6-,12-, and 18- months post-stroke. 

We will model outcomes as individual and group trajectories, allowing us to develop individual 

predictions which could inform clinical planning and decision-making for new patients. The Specific 

Aims are to: Aim 1: Establish a prospective cohort of stroke patients with aphasia, and define their 

typical trajectory of linguistic, cognitive-communicative, and health-related QoL recovery at admission 

to and discharge from the IRF, and at 6, 12, and 18 months post onset. Aim 2: Identify factors that are 

associated with linguistic, cognitive-communicative, and health-related QoL outcomes from among the 

following: patient factors including demographic and clinical characteristics related to stroke and 

aphasia; treatment variables including inpatient and outpatient aphasia therapy characteristics and 

informal aphasia services; and biomarkers, including genetic and neuroimaging biomarkers. Aim 3: 

Evaluate the stability of the models of linguistic, cognitive-communicative, and health-related QoL outcomes recovery that are developed from Aims 1 and 2. This study is innovative in its use of (1) 

standardized assessments that measure not only linguistic outcomes but also communication and QoL 

outcomes; (2) patient-centered, self-report instruments such as Neuro-QoL to detect clinically important 

change through 18 months post-stroke; (3) individual growth curve analysis to describe recovery 

trajectories and examine associations between demographic, lesion, aphasia, genetic, and speech and 

language therapy characteristics; (4) biomarkers that have been implicated in promoting neuroplasticity; 

(5) resting state functional magnetic resonance imaging to evaluate the association between network 

pathology and recovery from aphasia; (6) information on type, amount, and duration of aphasia 

treatment provided in clinical settings; and (7) information on informal aphasia services following 

discharge from formal therapy. 

PUBLIC HEALTH RELEVANCE: This study describes trajectories of linguistic, cognitivecommunicative, and health-related QoL outcomes during inpatient and outpatient rehabilitation to 18 

months in a sample of 300 adults with aphasia using demographic, lesion, aphasia, genetic 

polymorphisms, and speech and language therapy characteristics as predictors. 

CRITIQUE 1 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

1 R01 DC017174-01A1 3 LCOM 

HEINEMANN, A 

Significance: 2 

Investigator(s): 3 

Innovation: 2 

Approach: 3 

Environment: 1 

Overall Impact: This resubmitted multi-site study from an accomplished pair of PIs, leading a large and 

multi-faceted investigative team, aims to measure the trajectory of aphasia recovery across multiple 

dimensions over an 18-month window during the course of typical rehabilitation for stroke survivors. 

Determining the typical path of recovery over longer time periods is key to formulating prognosis 

statements and evaluating the effectiveness of aphasia treatments – this evidence is currently 

systematically lacking in the aphasia-treatment literature, representing a significant barrier to progress. 

If successful, this project would represent a key step toward attaining these critical healthcare goals. 

The proposed study will collect a wide range of measures – including clinical treatment records, 

multiple genomic measures, and both functional and structural neuroimaging measures – and relate 

them to language-impairment, communicative participation and health-related quality of life outcomes in 

a large sample of stroke survivors. The project is ambitious but feasible given the multi-site 

collaboration, and the measures to be collected (particularly the language/communicative outcomes 

and the genomic measures) are well selected and rigorous. The proposed analysis plans are well 

thought out and innovative; the use of multiple genomic measures relevant to neuroplasticity (key to 

stroke recovery) is also noteworthy and innovative. Furthermore, the plan to examine how dosage of 

standard-of-care aphasia rehabilitation impacts recovery is rare and is another noteworthy strength of 

the proposal. These notable strengths are somewhat offset by a lack of theoretical innovation and 

impact, and by some underspecified or unclear aspects of the approach, particularly related to the 

analysis plans. There are also some concerns regarding the management and coordination of this 

large, multi-site investigative team. However, these weaknesses only somewhat qualify enthusiasm for 

this ambitious proposal’s high potential clinical impact. 

1. Significance: 

Strengths 

 Understanding the trajectory of aphasia recovery in detail and over extended time-windows 

(longer than 6-12 months) is of very high clinical significance – it is key to formulating prognosis 

statements and to evaluating the effectiveness of aphasia treatments. If successful, this project 

would represent a significant step toward attaining this critical healthcare goal. 

 Identifying factors (both treatment-related and person-related) that are predictive of ultimate 

outcomes and the slope (trajectory) of recovery would significantly advance personalized 

aphasia intervention – this is a significant strength. 

 Measuring recovery of not only language and communicative function but health-related quality 

of life (QoL) is unusual among aphasia studies, and a noteworthy strength. 

 Focus on the contribution of aphasia treatment as provided in “real-world” clinical settings to 

language/communicative and QoL outcomes is rare and noteworthy. 

 Premise: Preliminary clinical data from a large sample of stroke survivors (n=71) compellingly 

demonstrates that there is natural significant variation in language-treatment, motivating aim to 

examine the impact of such variation on outcomes. 

Weaknesses 

 The proposed model of the factors that interact to predict recovery (Fig. 2) is descriptive rather 

than substantive, and does not provide insight or make predictions regarding the relative weight 

or importance of the multiple factors that may contribute to recovery. 
 

 

 

 

 

 

 

 

 

 

 

1 R01 DC017174-01A1 4 LCOM 

HEINEMANN, A 

 The proposal’s specific hypotheses and predictions regarding the impact of different factors on 

language, communicative, and QoL recovery (see Approach: Aims and Hypotheses, especially 

Hypothesis 1, Hypotheses 2a-c) are for the most part intuitive and unsurprising. This reduces 

the significance of the proposal’s theoretical contributions (although this is offset by the study’s 

high potential clinical significance). 

 No hypotheses are proposed regarding which of the multiple sets of neuroimaging measures 

(functional and structural, targeting both grey and white matter) is likely to be associated with 

recovery, despite significant discussion in the aphasia and neuroimaging literature regarding the 

neural substrates of aphasia recovery. This is not a fatal flaw, but it again detracts from the 

theoretical significance and impact of the proposal. 

 Premise: Preliminary data related to the rs-fMRI and lesion-related measures (from a sample of 

8 PWA) remain sparse and somewhat uncompelling. 

2. Investigator(s): 

Strengths 

 MPI Cherney is a renowned expert in the study of aphasia and aphasia recovery and is wellpositioned to lead aphasia-specific aspects the study. 

 MPI Heinemann has significant experience in stroke recovery, in study of quality of life poststroke, and with multi-site studies, and he has a record of collaboration with MPI Cherney. 

 Co-I Kozlowski provides key expertise in person-level growth curve analyses (a core analytical 

method to be used to model recovery). 

 Co-I Baliki brings key expertise in neuroimaging methods, including recent work with PI Cherney 

on neuroimaging in stroke. 

 The specific roles and contributions of the investigators are better specified in this revised 

application. 

Weaknesses 

 The study team is very large, and there are concerns regarding how effective study-team 

management and coordination will be maintained, both within and across sites. 

 The study team appears to include senior/key personnel who are not listed as such, like 

Rosalind Hurwitz (research SLP at SRAL, who will devote 6 calendar months effort and will 

oversee aphasia-related training across all sites), co-I (biostatistician at 

Northwestern), and Site Coordinator Roberta Virva (Mary Free Bed site). These may be 

oversights but they reinforce concerns regarding coordination and management of the large, 

multi-site study team. 

3. Innovation: 

Strengths 

 Proposed very large sample size (n=300 in final sample) and very broad array of variables to be 

collected (treatment history; multiple genomic assays; rs-fMRI; demographic, health, and other 

person-level variables) represents a very significant novel contribution – this data set would be 

unique in the study of aphasia recovery. 

 Plan to study the impact of genomic factors related to neuroplasticity on aphasia recovery (in 

particular, the joint influence of multiple genomic factors) is highly innovative. 
 

 

 

 

 

 

 

 

 

 

1 R01 DC017174-01A1 5 LCOM 

HEINEMANN, A 

 Use of individual growth-curve analyses to model recovery is innovative. 

 Following stroke survivors for 18 months and evaluating their trajectory of recovery over such an 

extended period is novel and noteworthy. 

Weaknesses 

 Use of rs-fMRI and white-matter imaging to study aphasia and aphasia recovery is only 

modestly innovative. 

4. Approach: 

Strengths 

 The study has ample resources for participant recruitment and referral across the three sites, 

ensuring feasibility – this is a significant strength. 

 The proposal uses a broad and well-chosen mix of measures (including impairment- and 

participation-focused, surrogate- and patient-reported) to characterize the language and 

communicative function and the health-related QoL of participants – this is a significant strength. 

 The plan to capture clinical data regarding treatment dosage and to use those data for models 

relating treatment to recovery is clever, and a significant strength. 

 The analysis approach for Aim 2 – first fitting separate multilevel individual growth-curve models 

of outcome variables for the demographic, treatment-related, neuroimaging, and genomic 

measures (treated the measures as fixed effects), and then building more complex models 

based on combinations of these fixed effects, assessing changes in model fit as a way of 

estimating which combination of factors explains the most variance – is clever (although see 

concerns below regarding multiple comparisons associated with this analysis strategy). This is a 

strength. 

 The plan to use multifactor dimensionality reduction methods to identify patterns in the genomic 

measures, and to reduce the number of genomic predictor variables, appears sound and would 

seem to be a strength. 

 The plan to use bootstrapping and cross-validation to assess the stability of fitted models is a 

strength. 

 Rigor: Chosen language, communication, and QoL measures are well validated and have 

strong measurement properties. 

 Rigor: There are detailed plans for characterizing the variability in the sample, along multiple 

dimensions, and assessing the impact of this variability on outcomes 

Weaknesses 

 The proposal still has not addressed the concern (raised in the previous round of reviews) that 

there may be sample bias due to attrition -- i.e., people with poorer overall health or greater 

numbers of comorbidities will be more likely to be among those who drop out – and that this will 

bias limit generalizability of the findings. Especially given the proposal’s strong health-servicedelivery focus and clinical significance, this is a notable weakness. 

 The sample size for proposed individual growth-curve analyses are below those recommended 

for this analysis method (n=300 instead of 500, as noted in the proposal); this is not a fatal flaw, 

but does suggest that the study may be underpowered to detect effects of interest, and no 

alternative analysis plan is provided. This is a moderate weakness. 

 The proposed model of the factors that condition aphasia recovery (Figure 2) is implicitly a 

mediation model, claiming that person-level characteristics have both direct and indirect effects 
 

 

 

 

 

 

 

 

 

 

 

 

 

1 R01 DC017174-01A1 6 LCOM 

HEINEMANN, A 

(mediated through treatment) on outcomes. This model would be most appropriately tested 

through SEM analysis, which would permit quantification of the weight of the different links in 

the model, as well as direct assessment of this mediation claim; however, no such plan is 

proposed. This is a moderate (addressable) weakness. 

 The analysis plan for the neuroimaging measures remains underspecified. Some indication is 

provided regarding the set of anatomical and functional measures to be collected (see Table 5) 

and the processing pipeline for these measures is now described in the Approach. However, it 

is unclear whether the measures will be fit to separate models to address Aim 2c, or whether 

some dimension-reduction methods will be used for neuroimaging measures to create omnibus 

measures for fitting individual growth curves. This is a modest (addressable) weakness. 

 The analysis plan related to demographic measures is also underspecified. Under Table 3, the 

proposal notes that the NINDS Common Data Elements will be collected, but this set is not fully 

specified, and it is unclear whether the measures will be fit to separate models to address Aim 

2a or whether (as for neuroimaging measures) dimension-reduction methods will be used for 

demographic data. This is a modest (addressable) weakness. 

 The analysis plan involves fitting separate individual growth curve models for each primary and 

secondary outcome (there appear to be 15 such outcomes, given Table 3). No plan is provided 

to correct for multiple comparisons across these models (this is necessary, given that the 

different outcomes are taken from the same sample and are likely collinear). Similarly, there is 

no plan to correct for multiple comparisons across the multiple models used to test Aim 2 

hypotheses. This is an addressable weakness. However, correcting for these multiple 

comparisons (using family-wide error methods, for example) will again reduce the power of the 

analyses to detect effects of interest, hampering the study’s ability to provide definitive answers 

to the important clinical questions it is posing. 

5. Environment: 

Strengths 

 The Shirley Ryan Ability Lab provides a superb environment for large-scale studies of stroke 

recovery and aphasia recovery, and is well-suited to serve as lead site in the proposed multi-site 

collaboration. 

 Facilities and support for genomic and neuroimaging procedures are excellent. 

 The partner sites (Alexian Brothers and Mary Free Bed Rehabilitation Hospitals) have a history 

of collaboration with the lead site. 

Weaknesses 

 No major weaknesses noted. 

Study Timeline: 

Not applicable (No Clinical Trials) 

Protections for Human Subjects: 

Acceptable Risks and/or Adequate Protections 

 No concerns noted. 

Data and Safety Monitoring Plan (Applicable for Clinical Trials Only): 

Acceptable 
 

 

 

 

 

 

 

 

1 R01 DC017174-01A1 7 LCOM 

HEINEMANN, A 

 No concerns noted. 

Inclusion of Women, Minorities and Children: 

 Sex/Gender: Distribution justified scientifically 

 Race/Ethnicity: Distribution justified scientifically 

 For NIH-Defined Phase III trials, Plans for valid design and analysis: Not applicable 

 Inclusion/Exclusion of Children under 18: Excluding ages <18; justified scientifically 

 The distribution of race/ethnicity across sites is well described and characterized. 

Vertebrate Animals: 

Not Applicable (No Vertebrate Animals) 

Biohazards: 

Not Applicable (No Biohazards) 

Resubmission: 

 This resubmission has been responsive to the previous round of reviews, providing helpful 

additional details regarding genomic testing and rs-fMRI procedures, an explicit model of factors 

that may contribute to stroke recovery, and modified analysis plans. 

Resource Sharing Plans: 

Acceptable 

 Plans to ensure confidentiality of participants and to establish data-use agreements are 

somewhat underspecified but appear adequate. 

Authentication of Key Biological and/or Chemical Resources: 

Not Applicable (No Relevant Resources) 

Budget and Period of Support: 

Recommend as Requested 

CRITIQUE 2 

Significance: 1 

Investigator(s): 1 

Innovation: 2 

Approach: 2 

Environment: 2 

Overall Impact: This resubmitted multiple PI plan comes from a talented team of researchers with 

complementary expertise in the measurement of aphasia and neuropsychosocial outcomes post stroke. 
 

 

 

 

 

 

 

 

 

 

 

1 R01 DC017174-01A1 8 LCOM 

HEINEMANN, A 

The investigators were particularly responsive to the initial critique, adding essential rigor to a proposal 

with many extant strengths. Long-term disability is a major concern in the trajectory of recovery from 

post-stroke aphasia. The investigators note that only about 25% of the variance in functional recovery 

is attributable to therapy intensity. Therefore, there exists a compelling public health need to develop a 

broader understanding of the predictors of recovery. This is an essential step toward developing 

effective, personalized medicine approaches to rehabilitation. This holistic perspective is a major 

strength of the premise of the research. The investigators are characterizing longitudinal change under 

the auspices of a path model integrating numerous biomarkers, including genotype and resting state 

fMRI. Rigor and reproducibility are both high, and the potential contribution to theory is excellent. 

1. Significance: 

Strengths 

 Much remains unclear about the trajectory of aphasia recovery and the role(s) of specific 

biomarkers. Previous work on treatment outcomes in aphasia has focused almost exclusively 

on dose and treatment efficacy. The current proposal situates treatment as just one variable 

among many others that conspire to influence outcomes in post stroke aphasia. This holistic 

approach is a major advance for a field that has shown limitations in treatment effectiveness. 

Weaknesses 

 No major weaknesses noted. 

2. Investigator(s): 

Strengths 

 The MPI plan includes complementary expertise in the measurement of outcomes and aphasia 

treatment. The investigative team is world class. There is perhaps no stronger or better suited 

group to undertake this complex project. 

Weaknesses 

 No major weaknesses noted. 

3. Innovation: 

Strengths 

 The perspective of nesting patients within a systems level framework integrating multiple 

biomarkers is exceptionally innovative. 

Weaknesses 

 Although not an explicit weakness, the measures used to track longitudinal change are wellworn (e.g., rsFMRI). 

4. Approach: 

Strengths 

 Sample size and diversity of the metrics are major strengths of the approach. 

 The use of linear mixed effects models is an added strength of the statistical approach. 

 The multi-site data collection proposal improves sample representativeness. 

Weaknesses 
 

 

 

 

 

 

1 R01 DC017174-01A1 9 LCOM 

HEINEMANN, A 

 The overarching model (Figure 2) seems more like a crude box-and-arrow approach then a 

testable path model. 

5. Environment: 

Strengths 

 The research will take place at the Rehabilitation Institute of Chicago, with tertiary data 

collection at two additional centers. The environment is exceptional both in terms of research 

infrastructure and the supportive intellectual community. An added strength is a wellestablished patient recruiting pipeline. 

Weaknesses 

 No major weaknesses noted. 

Study Timeline: 

Strengths 

 The study timeline is extremely detailed, and although ambitious, the goals appear achievable 

for this talented group. 

Weaknesses 

 No major weaknesses noted. 

Protections for Human Subjects: 

Acceptable Risks and/or Adequate Protections 

 Primary risks include MRI, fatigue, and data confidentiality. These risks appear to be wellmitigated. 

Data and Safety Monitoring Plan (Applicable for Clinical Trials Only): 

Acceptable 

 The DSMP is well-planned and comprehensive. 

Inclusion of Women, Minorities and Children: 

 Sex/Gender: Distribution justified scientifically 

 Race/Ethnicity: Distribution justified scientifically 

 For NIH-Defined Phase III trials, Plans for valid design and analysis: Not applicable 

 Inclusion/Exclusion of Children under 18: Excluding ages <18; justified scientifically 

 Reasonable exclusion of children; recruitment based on population demographics for three 

sites. 

Vertebrate Animals: 

Not Applicable (No Vertebrate Animals) 

Biohazards: 
 

 

 

 

 

 

1 R01 DC017174-01A1 10 LCOM 

HEINEMANN, A 

Not Applicable (No Biohazards) 

Resubmission: 

 The resubmission was highly responsive to the initial round of reviews. 

Authentication of Key Biological and/or Chemical Resources: 

Acceptable 

Budget and Period of Support: 

Recommended budget modifications or possible overlap identified: 

 Multi-site, MPI study - expenses reasonably justified 

CRITIQUE 3 

Significance: 2 

Investigator(s): 2 

Innovation: 2 

Approach: 2 

Environment: 2 

Overall Impact: Aphasia is a particularly devastating result of stroke that significantly affects quality of 

life, but studies are often focused on impairment-based treatments rather than more holistic 

considerations, and assess beginning and ending timepoints rather than modeling individual 

trajectories. This proposal evaluates the effects of multiple environmental and biologic variables to 

predict treatment response over time, and would be a valuable contribution to the guidance of effective 

and efficient therapy. The proposal is responsive to previous review. 

1. Significance: 

Strengths 

 Focus on quality of life rather than just correction of deficits 

 Aphasia decreases quality of life when physical effects of stroke and other factors are 

controlled, but response to treatment is harder to predict. Evidence-based modeling of trajectory 

will be valuable in guiding treatment planning. This study provides a comprehensive study with 

large sample size. 

Weaknesses 

 No major weaknesses noted. 

2. Investigator(s): 

Strengths 

 Dr. Heinemann has expertise in stroke rehabilitation and quality of life assessments, and Co-PI 

Dr. Cherney has complementary expertise in aphasia therapy. They are well qualified to lead 

this study and have a history of productive collaboration. A multiple PI agreement is in place. Dr. 

Domenighetti has previous experience in the study of neural plasticity and SNP analysis of 
 

 

 

 

 

 

1 R01 DC017174-01A1 11 LCOM 

HEINEMANN, A 

candidate genes, and Dr. Baliki brings experience in neuroimaging. The rest of the team has the 

clinical and statistical experience necessary for the project. 

Weaknesses 

 No major weaknesses noted. 

3. Innovation: 

Strengths 

 The project is innovative in its scope, including language and quality of life outcomes and a 

variety of environmental and biologic variables that can predict the trajectory of response to 

therapy, and the large size of the study population should give more reliable results. 

Weaknesses 

 No major weaknesses noted. 

4. Approach: 

Strengths 

 Use of trajectory modeling allows for more comprehensive analysis of the effects of covariates 

on improvement, resulting in better prediction and identification of plateaus in improvement 

 Power analyses are discussed, citing the limitations of methods to calculate power in a this type 

of growth curve modeling study, but showing that the sample size is likely to be sufficient 

 Preliminary data on brain lesion characteristics and connectivity are available that support the 

modeling approach 

Weaknesses 

 Validation in a separate population would be ideal, but the bootstrapping analyses would 

identifiy problems in the model. 

5. Environment: 

Strengths 

 The inclusion of three facilities will assure that there is a sufficient number of participants, and 

their relative proximity aids in communication across sites so that the procedures are consistent. 

Weaknesses 

 No major weaknesses noted. 

Study Timeline: 

Strengths 

 The timeline is provided and is realistic. 

Weaknesses 

 No major weaknesses noted. 

Protections for Human Subjects: 
 

 

 

 

 

1 R01 DC017174-01A1 12 LCOM 

HEINEMANN, A 

Acceptable Risks and/or Adequate Protections 

 The research involves minimal risk and includes assessments that would be typical for stroke 

patients. Appropriate protections are in place to maintain confidentiality of the data. 

Data and Safety Monitoring Plan (Applicable for Clinical Trials Only): 

Acceptable 

 A Data Safety and Monitoring Committee will be created even though this is not a clinical trial. 

Inclusion of Women, Minorities and Children: 

 Sex/Gender: Distribution justified scientifically 

 Race/Ethnicity: Distribution justified scientifically 

 For NIH-Defined Phase III trials, Plans for valid design and analysis: Not applicable 

 Inclusion/Exclusion of Children under 18: Excluding ages <18; justified scientifically 

 There are no restrictions by sex/gender nor race/ethnicity, so these should be adequately 

represented. Adults are included and it is anticipated that most will be over 50 since this is the 

population most likely to experience stroke. 

Vertebrate Animals: 

Not Applicable (No Vertebrate Animals) 

Biohazards: 

Not Applicable (No Biohazards) 

Resubmission: 

 The resubmission is responsive to previous critiques 

Resource Sharing Plans: 

Acceptable 

 A data sharing plan is included and is appropriate. 

Authentication of Key Biological and/or Chemical Resources: 

Not Applicable (No Relevant Resources) 

Budget and Period of Support: 

Recommend as Requested 

THE FOLLOWING SECTIONS WERE PREPARED BY THE SCIENTIFIC REVIEW OFFICER TO 

SUMMARIZE THE OUTCOME OF DISCUSSIONS OF THE REVIEW COMMITTEE, OR REVIEWERS’ 

WRITTEN CRITIQUES, ON THE FOLLOWING ISSUES: 

PROTECTION OF HUMAN SUBJECTS: ACCEPTABLE 
 

 

 

1 R01 DC017174-01A1 13 LCOM 

HEINEMANN, A 

INCLUSION OF WOMEN PLAN: ACCEPTABLE 

INCLUSION OF MINORITIES PLAN: ACCEPTABLE 

INCLUSION OF CHILDREN PLAN: ACCEPTABLE 

COMMITTEE BUDGET RECOMMENDATIONS: The budget was recommended as requested. 

Footnotes for 1 R01 DC017174-01A1; PI Name: Heinemann, Allen Walter 

NIH has modified its policy regarding the receipt of resubmissions (amended applications). 

See Guide Notice NOT-OD-14-074 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD14-074.html. The impact/priority score is calculated after discussion of an application by 

averaging the overall scores (1-9) given by all voting reviewers on the committee and 

multiplying by 10. The criterion scores are submitted prior to the meeting by the individual 

reviewers assigned to an application, and are not discussed specifically at the review meeting 

or calculated into the overall impact score. Some applications also receive a percentile 

ranking. For details on the review process, see 

http://grants.nih.gov/grants/peer_review_process.htm#scoring. 
MEETING ROSTER 

Language and Communication Study Section 

Biobehavioral and Behavioral Processes Integrated Review Group 

CENTER FOR SCIENTIFIC REVIEW 

LCOM 

10/18/2018 - 10/19/2018 

Notice of NIH Policy to All Applicants: Meeting rosters are provided for information purposes only. Applicant 

investigators and institutional officials must not communicate directly with study section members about an 

application before or after the review. Failure to observe this policy will create a serious breach of integrity 

in the peer review process, and may lead to actions outlined in NOT-OD-14-073 at 

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-073.html and NOT-OD-15-106 at 

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-106.html, including removal of the application from 

immediate review. 
SCIENTIFIC REVIEW OFFICER 

EXTRAMURAL SUPPORT ASSISTANT 

• Temporary Member. For grant app cat ons, temporary members 

may part c pate n the ent re meet ng or may rev ew on y se ected 

app cat ons as needed. 

Consu tants are requ red to absent themse ves from the room 

dur ng the rev ew of any app cat on f the r presence wou d 

const tute or appear to cons! lute a conf ct of nterest.