Effects of Bodily Illusion and tDCS on Spinal Cord Injury (SCI) Related Neuropathic Pain
Phase: NA
Conditions: Neuropathic Pain
Sponsor: University of Miami

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Title Page
Protocol Title:  Effects of bodily illusion and tDCS on SCI-related 
neuropathic pain
Protocol Number: 20200841 eProst ID number
Date: 2/21/24
Version 1.0
PI Name: Dr. Widerstrom-Noga Eva
NCT Number: NCT04578574
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1)
Protocol Title
Effects of bodily illusion and tDCS on SCI-related neuropathic pain
2)
Objectives
Specific Aim #1: We aim to determine to what extent neuropathic pain 
following spinal cord injury (SCI) is reduced after a non-pharmacological 
treatment involving bodily illusion (BI) and transcranial Direct Current 
Stimulation (tDCS).
Specific Aim #2: We aim to determine the relationship between Body 
Representation (BR) and neuropathic pain after SCI by investigating BR 
measures (e.g. body image task) before and after the exposure to BI and 
tDCS. Electrophysiological (EEG) measures before and after exposure to 
BI and tDCS will be also investigated.
The working hypothesis is that a manipulation of the BR through a long 
exposure of BI and tDCS will reduce neuropathic pain symptom severity 
and sensory abnormalities. Moreover, this research will provide insights 
into changes of BR and EEG measures after SCI so far neglected, given the 
measures of EEG and body image task taken before and after BI-tDCS.
3)
Background
Following SCI persistent neuropathic pain is a common clinical condition 
that negatively influences quality of life (QoL) and independent living of  
SCI individuals by interfering with sleep, mood, physical and social 
activities (Wollaars et al., 2007). Unfortunately, the neuropathic pains that 
occur after SCI are often inadequately relieved by available treatments, with 
pharmacological gold standard treatments reducing pain by 50% or more in 
only one person out of seven (Cardenas et al., 2013). Thus, 
interdisciplinary, multimodal treatment approaches are particularly 
important to consider in this population. Indeed, our recent qualitative 
research shows that a priority of many SCI individuals who experience 
severe neuropathic pain is to have better access to non-pharmacological 
treatment options.
Research shows that non-pharmacological intervention that synergistically 
modulates neural activity with the purpose of inducing changes in body 
representation (BR) decreases neuropathic pain (Moseley, 2007; Soler et al., 
2010). In particular the combination of tDCS (a non-invasive brain 
stimulation able to modulate neural excitability, depending on the polarity 
of stimulation) and different types of bodily illusions (like, rubber hand 
illusions and walking illusion) to manipulate BR induce analgesic effects 
(Soler et al., 2010).
Body representation is a multidimensional concept requiring the integration 
and organization of multiple sensory inputs, such as somatosensory, 
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proprioceptive and kinesthetic coming from skin, joints and muscles with 
visual information (Carruthers, 2008; Deneve & Pouget, 2004; Longo et 
al., 2010). Under normal circumstances these information are integrated to 
provide a coherent sense of one’s own body (Longo et al., 2010). BR can 
be manipulated by using non-invasive approaches that manipulates the 
interaction between vision, touch and proprioception, such as the rubber 
hand illusion (RHI) (Botvinick & Cohen, 1998; Tsakiris & Haggard, 2005) 
and walking illusion (WI) (Moseley, 2007; Soler et al., 2010). In the RHI a 
prosthetic hand brushed synchronously with a participant’s own hand is 
perceived being part of the participant’s own body. Similarly in the WI a 
participant on a wheelchair can see his/her upper body on a mirror, while 
the lower part of the body is a projection on the screen of legs in motion. 
Both illusions are able to manipulate BR through vision and proprioceptive 
manipulations and reduce neuropathic pain.
In addition the use of tDCS over specific brain areas (e,g,. motor cortex) in 
combination with bodily illusions has been used to treat neuropathic pain 
given the long lasting analgesic effect. Moreover, the modulations of 
embodiment processes for an artificial limb (e.g. RHI), such as the sense of 
body ownership, have been shown to be induced by tDCS over posterior 
parietal cortical (PPC) areas. There is therefore evidence that modulation of 
PPC can temporarily induce changes in body representation. 
Finally, EEG research(Boord et al., 2008; Vuckovic et al., 2014) suggests 
that SCI-related neuropathic pain is associated with increased EEG power 
spectra in the theta range (4–7 Hz) and decreased power in alpha (8–13 Hz) 
and beta (13-20 Hz). These power spectra variations are attributed to altered 
inputs from the thalamus, a phenomenon known thalamocortical 
dysrhythmia. Brain rhythms can be modulated via non-invasive 
neuromodulatory interventions. For instance, tDCS induces neuronal 
membrane excitability that leads to changes in cortical activity. Anodal 
tDCS has been shown to modulate spontaneous oscillatory brain activity in 
the resting brain (e.g., an increase in alpha and beta power) after 
stimulation(Mangia et al., 2014). In addition tDCS over posterior parietal 
cortical areas has been shown to modulate aspects of multisensory body 
representation and increase cortical response to incoming visuo-spatial 
stimuli(Grasso et al., 2020; Spitoni et al., 2013) important for body 
representation. 
In this protocol we aim to stimulate PPC by using tDCS or sham (inactive 
t-DCS) and at the participants will undergo to bodily illusion (BI) sessions.
4)
Study Design
Purpose: The study is a pilot study investigating to what extent neuropathic 
pain is reduced after BI-tDCS stimulation in participants with SCI and 
neuropathic pain. (See also objectives above)
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Number of Participants: In this pilot study 16 participants with SCI and 
neuropathic pain will be enrolled.
Number of study arms: two study arms
Study model: Experimental arm (half participants will undergo BI-tDCS ) 
and Sham comparator arm (half participants will undergo BI- inactive 
tDCS).
Inclusion and Exclusion Criteria
Inclusion criteria
SCI and chronic pain (SCICP) group (N=16): Participants will be men or 
women, 18-75 years of age, with an incomplete cervical traumatic SCI. 
Participants must have experienced neuropathic pain for a minimum of six 
months. They must have neuropathic pain in the moderate to severe 
category, which will be defined as a score of at least 4 on a NRS (range of 
0 to 10). Participants must be willing and able to sign informed consent. 
Exclusion criteria
General: Candidates will be excluded if they have: (1) major psychiatric 
disease/disorder (self-reported); (2) a significant neurological trauma 
besides SCI (3) a recent (one-year) history of alcohol or drug abuse (self-
reported); (4) any other medical conditions in which transcranial DCS is 
relatively contraindicated, such as pregnancy, epilepsy and/or seizures.
Arms and Interventions
Groups
Arms and Interventions
Intervention
Group 1 (8 SCI with Pain)
Experimental arm
BI-tDCS over 2-4 weeks
Group 2 (8 SCI with Pain)
Sham comparator arm
BI-inactive tDCS over 2-4 weeks
Procedures Involved
Participants will complete Pain/Sensory examination, EEG recording at rest and BR 
measures before BI and tDCS exposure (or BI and inactive tDCS: sham) (PRE-Session 
1), then they will undergo 10 study sessions of BI and tDCS (or sham), 30 min, during a 
period of 2-4 weeks (from Monday to Friday) (Sessions 2-11). Finally, they will 
complete Pain/Sensory examination, EEG recording at rest and BR measures after BI and 
tDCS exposure (or sham) (POST- Session 12).  See details below.
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Session 1 - Baseline
Sessions 2-11
Session 12
Screening:
Information on Injury; Age; Sex; BMI, 
Inclusion/Exclusion criteria listed above
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BR measures:
Computer task: mental rotation of body parts
BR measures
EEG recording at rest
EEG recording at rest
Sensory and Pain Assessment:
QST; NPSI; ISCIPBDS; PGIC
Sensory and Pain 
Assessment
Other Questionnaires:
PGWBI; BDI; CDS, Illusion measure
BI-tDCS
Other Questionnaires
  
PRE-Session (1). This session is done in a single visit of a duration of three hours, 
however, if necessary, we will  divide the tests in 2 visits over 1 week, to meet 
participants’ need. 
BR measures: A computer task (mental rotation of body parts) will be performed 
PRE and POST BI-tDCS (or BI and inactive tDCS:sham). The mental rotation of 
body parts is assumed to activate somatosensory representations, such as the body 
schema. In this task participants will be instructed to perform a computer task: the 
mental rotation task of body parts. They will observe images of hands or feet (left 
and right) on a computer screen or objects (left or right oriented) in different angle 
orientation and they will have to judge the laterality of the image (left or right). 
Reaction times will be measured and defined as a difference from image onset and 
participant’s vocal response, accuracy (correct responses) will be also evaluated.  
EEG recording at rest: A 64-channel Biosemi EEG-system will be used to record 
cortical activity under two conditions of 5 min each: while subjects will rest with 
their eyes closed (EC), and while they will rest with their eyes open (EO) keeping 
the gaze on a fixation cross in the middle of a computer screen. These measures 
will be performed at baseline (PRE) and directly after treatment completion (BI-
tDCS or BI-sham) (POST). Absolute spectral power will be calculated in the 
frequency range of 4–35 Hz, as we will focus our analysis on theta (4–7 Hz), alpha 
(8–13 Hz), low beta (13-20 Hz) and high beta (20-30 Hz).
Questionnaires: First they will be requested to report their height and weight to 
calculate body mass index (BMI). Participants will be also asked to complete 4 
questionnaires: the Neuropathic Pain Symptom Inventory (NPSI), psychological 
general well-being index (PGWBI) questionnaire, the Beck Depression Inventory-
II (BDI-II) and the Cambridge Depersonalization Scale. We will also perform a 
pain assessment using the Pain Basic Data Set where participants will describe their 
pains and provide the Patients’ Global Impression of Change (PGIC):
1.The psychological general well-being index, The PGWBI is a validated Health 
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Related Quality of Life (HRQoL) measure, widely used in clinical trials and 
epidemiological research to provide a general evaluation of self-perceived 
psychological health and well-being. Participants are required to indicate the 
answer that best applies to them, choosing one of the 6 options (Grossi et al., 2006). 
It is composed of 22 items, rated on a 6-point scale (0 to 5). The scores for all items 
can be summarized into a summary score, which reaches a maximum of 110 points, 
representing the best achievable level of well-being.
2.Beck Depression Inventory, 2nd Edition (BDI): The BDI is a self-report multiple 
choice questionnaire designed to assess depressive symptoms (Steer et al., 2001). 
Participants are required to rate their symptoms over the past two weeks from 0-3 
with increasing scores reflecting greater symptomatology. It is composed of 21 
items. Each item is rated on a 4-point scale ranging from 0 to 3. Range of 
depression: 0–13 minimal, 14–19 mild, 20–28 moderate, and 29–63 severe.
3.The Cambridge Depersonalization Scale is a well-validated scale designed to 
assess disturbance of the apparent reality of one’s physical states, as well as, altered 
perception of bodily experience. Participants are required to indicate the Frequency 
(from 0 to 4) and the Duration (from 1 to 6) of the bodily experiences that they may 
have in their life (Sierra & Berrios, 2000). It is composed by 29 items. Each one of 
the 29 items is rated on two independent Likert scales, one for frequency and 
duration. A total score is calculated by adding all item scores. It has been 
established a score cut off of 70, >70 it is considered a depersonalization disorder.
4.Neuropathic Pain Symptom Inventory (NPSI): The NPSI (Bouhassira et al., 
2005) assesses pain symptom severity associated with neuropathic pain. The NPSI 
is a 12 items questionnaire with a range of scores from 0 to 10 for all items, except 
for questions number 4 and 7 where the response is open. With a Total score 
maximum of 100 (summation of the 10 items except of item 4 and 7) indicating a 
clinically relevant dimension of neuropathic pain syndrome. The NPSI is also 
constituted of 5 subscales with a maximum total score of 10, indicating the specific 
dimensions of pain (burning, pressing, paroxysmal pain, evoked pain and 
paresthesia/dysesthesia). The NPSI includes severity ratings of 10 pain descriptors 
reflecting spontaneous ongoing or paroxysmal pain, evoked pain (i.e. mechanical 
and thermal allodynia/hyperalgesia) and dysesthesia/ paresthesia. In addition, the 
NPSI includes two temporal items for duration of spontaneous ongoing pain and 
paroxysmal pain. The NPSI allows discrimination and quantification of five distinct 
and clinically relevant dimensions of neuropathic pain. The NPSI has been shown 
to be both valid and reliable in heterogeneous chronic pain populations.
5. International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS) The 
ISCIPBDS is a brief instrument that contains questions about clinically relevant 
information concerning up to three separate pain problems during the last week 
including pain interference with sleep, activities, and mood, pain intensity, and pain 
classification (Widerström-Noga et al., 2014). Respondents are asked to rate the 
interference items on a 0 to 10 scale.
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Patients’ Global Impression of Change (PGIC): The PGIC scale was designed 
specifically to assess patients’ perception of changes following treatment (i.e., 
“feeling better” or “feeling worse”). It is a 7‐point verbal scale, with the options 
“very much improved” (3), “much improved” (2), “minimally improved” (0), “no 
change” (0), “minimally worsened” (-1) “much worsened” (-2), and “very much 
worsened” (-3). It has been demonstrated that the subjective “much improved” and 
“very much improved” ratings indicate moderately important and substantial 
improvement and the PGIC is widely used in neuropathic pain studies.
Sensory and Pain examination: All participants are required to have an AIS score. 
A trained examiner will conduct a standard neurological examination for SCI, 
including determination of the level of injury and classification on the American 
Spinal Injury Association (ASIA) Impairment Scale (AIS):
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Quantitative sensory testing (QST) using Medoc machine (Medoc Ltd, 
Ramat Yishai, Israel and FDA approved) The sensory assessment is 
intended to detect and quantify positive and negative sensory signs 
indicative of somatosensory (dys)function. A standardized QST 
protocol is commonly used in clinical and research settings to provide 
essential information regarding an individual’s sensory status and has 
been used extensively in our research group (Widerström-Noga et al., 
2016). As part of the QST protocol, we will also assess mechanical and 
thermal allodynia. Ascending somatosensory information is transmitted 
mainly via the dorsal column-medial lemniscal (body) and the 
trigeminal lemniscus (face) for innocuous tactile and proprioceptive 
sensations, and via the spinothalamic tract (body) and the 
trigeminothalamic tract (face) for thermal and pain sensations. 
Somatosensory thresholds will be measured at two standard test sites in 
all subjects, the right cheek, near angle of nose and the thenar eminence, 
center. The right cheek will be chosen because this site is above the level 
of injury for all subjects. 
-
Assessment of thermal allodynia: An allodynic response is a painful 
response evoked by a stimulus that is not normally painful. We will use 
two thermorollers [Somedic, Sweden], one set at 40°C (corresponding 
to approximately 7 degrees above normal skin temperature), and the 
other at 25°C (approximately 8 degrees below normal skin temperature). 
Moving the rollers along the skin surface enables quick location of areas 
with abnormal temperature sensibility. If the subject perceives the 
thermal sensation as pain, it will be interpreted as thermal allodynia and 
the subject will be asked to rate the sensation on an NRS.
-
Assessment of dynamic and static mechanical allodynia: Dynamic 
mechanical allodynia will be investigated similarly to the method 
described by (Cruz-Almeida et al., 2012), who used a soft brush and 
lightly brushed the skin in the painful area. If pain is evoked in a test 
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site, the participant will be asked to rate the pain intensity by using an 
NRS. Static mechanical allodynia will be assessed using Semmes-
Weinstein monofilaments. Evoked pain intensity will be rated on an 
NRS.
- Pain assessments:
Numerical Rating Scale (NRS): Numerical rating scales are widely 
accepted and used for the measurement of pain intensity. In this study, 
we will use this scale to assess the subjects’ ratings of pain sensation on 
a scale of 0 (no pain) to 10 (most intense pain imaginable).
For pain history, the International SCI Pain Basic Data Set (ISCIPBDS, 
version 2.0) will be used.
Session 2-11) BI-tDCS
Participants will undergo 10 study sessions of BI and tDCS, 30 min, during 
a period of 2-4 weeks (from Monday to Friday) (Sessions 2-11). We will 
allow for up to 3 missed sessions.  
BI procedure: Two types of illusions will be used 15 min each, the rubber 
hand illusion (RHI) and the walking illusion (WI) to target upper and lower 
limbs. In the RHI a prosthetic hand will rest inside a box in front of the 
subject’s midline at the same distance in front of the subject’s chest as the 
subject’s hand is. The entire box will be covered by a mirror, which prevents 
the subject from seeing their hand. The procedure requires that participants 
will only see the rubber hand while stimulated (tactile stimulation by using 
a paintbrush) and at the same time their hand will be also stimulated but 
hidden from their view. This will create a visual illusion as the fake hand 
will be perceived as one’s own hand. For the WI participants will sit in their 
wheelchair and a screen will be placed in front of them, composed by a half 
mirror (top part) and half projector-screen (bottom part). Participants will 
be instructed to move their upper body and observe themselves in the 
mirror, while online a video of a walking person will be projected on the 
half bottom part of the screen. This will give the illusion of walking. After 
each illusion we will ask participants questions about the strength of the 
illusion. We will use the body ownership subscale (5 items) of the 27 items 
that compose the psychometric perspective of the embodiment after bodily 
illusion by Longo et al. in 2008 (Longo et al., 2008). The 5 items of the 
questionnaire include questions about the feeling of body ownership of the 
rubber hand and virtual legs, the response options range from -3 (completely 
disagree) to +3 (completely agree). 
tDCS: Direct current will be delivered from a battery-driven, constant 
current stimulator (TCT Research Version, Hong Kong) using saline-
soaked surface sponge electrodes (35 cm2). The anode will be placed over 
P4 (EEG 10/20 system) to target the right Posterior Parietal Cortex (rPPC), 
and the cathode over the contralateral supraorbital area. This electrode 
position is chosen because rPPC has been shown to be involved in 
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multisensory integration, BR and localization of somatic stimuli (Azañón et 
al., 2010; De Vignemont, 2007; Makin et al., 2008; Wertheim et al., 2020). 
However, consistent with other tDCS studies on pain (Soler et al., 2010), 
where the site of stimulation is contralateral to the painful body-part, if 
participants have not bilateral pain and the painful site involves only the 
right side of the body, the anodal electrode will be placed on P3, the left 
Posterior Parietal cortex (lPPC), and be therefore contralateral to the painful 
body-part. A constant current of 2mA intensity will be applied for 30 min 
during the BI (15 min RHI plus 15 min WI). The duration of the stimulation 
has been chosen as used in previous works (Mameli et al., 2014; Ouellet et 
al., 2015).
In the sham session (inactive tDCS) there will be no stimulation. The 
procedure will be the same as the active tDCS but the machine will be 
turned off after 30 seconds. 
tDCS it is not a medical device and it is considered a non-significant-risk 
device, meaning that it is a technique without expectation of any Serious 
Adverse Effect (Bikson et al., 2016; Fregni et al., 2015).
In the United States tDCS is not FDA approved. Some companies have an 
FDA (Food and Drug Administration) regulation status of “investigational” 
which limits the device to investigational use and not for medical treatment 
(Fregni et al., 2015). In the European Union, Canada, Brazil, Australia, and 
Singapore, specific tDCS products have been approved for treatment of 
various neuropsychiatric disorders. (Fregni et al., 2015).
Research centers worldwide are allowed to test tDCS in controlled clinical 
trials. A list of tDCS trials can be found here: clinicaltrials.gov
POST- Session (12)
BR measures: The measure a computer task (mental rotation of body parts) will 
be performed also POST BI-tDCS (or sham) (See same procedure of PRE-Session 1 
above). This session is done in a single visit of a duration of three hours, however, if 
necessary, we will  divide the tests in 2 visits over 1 week, to meet participants’ need. 
5)
Data and Specimen Banking
NA
6)
Study Endpoints
For each objective: 
Specific Aim #1
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Primary Endpoint 
Although the total NPSI score is the tentative primary outcome measure in this pilot 
study, all NPSI subscales and other outcomes will be examined for change and may 
therefore potentially be considered a primary outcome in the final analyses.
Outcome Title: Change in neuropathic pain severity
Outcome Description: Assessed by the use of the Neuropathic Pain Symptom Inventory 
(NPSI).  The NPSI is a 12 items questionnaire with a range of scores from 0 to 10 for all 
items, except for questions number 4 and 7 where the response is open. With a Total score 
maximum of 100 (summation of the 10 items except of item 4 and 7) indicating a clinically 
relevant dimension of neuropathic pain syndrome. The NPSI is also constituted of 5 
subscales with a maximum total score of 10, indicating the specific dimensions of pain 
(burning, pressing, paroxysmal pain, evoked pain and paresthesia/dysesthesia). 
Outcome Timeframe: From Visit 1 (before tDCS-BI) to Visit 12 after10 study sessions 
(after tDCS-BI)
Secondary Endpoints
Although the change in sensory thresholds is a tentative secondary primary outcome 
measure in this pilot study, all QST modalities and other outcomes will be examined for 
change.
Outcome Title: Change in sensory thresholds
Outcome Description: Assessed by the Quantitative Sensory Testing. Thresholds for 
vibration, cool (1- 2ºC above adaptation temperature) and warm (1- 2ºC below adaptation 
temperature) temperature, cold (threshold around 45ºC) and hot (about 10º C ) pain. 
Expressed in 0-130 micron for vibration; 
Outcome Timeframe: From Visit 1 (before tDCS-BI) to Visit 12 after10 study sessions 
(after tDCS-BI)
Specific Aim #2
Primary Endpoint 
The change in RTs is a tentative primary outcome measure in this pilot study. Therefore 
other outcomes related to Aim 2 will be examined for change and may therefore potentially 
be considered a primary outcome in the final analyses
Outcome Title: Change in performance of body part processing
Outcome Description: Assessed by  a customized computer task, where individual reaction 
times will be measured in response to mental rotation of body parts. There is no a standard 
result, it depends on the RTs of each individual, usually from 250 ms to up 5000 ms, fastest 
and slowest response respectively in this kind of study.
Outcome Timeframe: From Visit 1 (before tDCS-BI) to Visit 12 after10 study sessions 
(after tDCS-BI)
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All other measures not listed in these Endpoints are exploratory and they will be 
examined for change and potentially be considered a primary outcome in the final 
analyses. 
Secondary Endpoints
The change in EEG measures is a tentative outcome measure in this pilot study. Therefore, 
other outcomes related to Aim 2 will be examined for change and may therefore potentially 
be considered a primary outcome in the final analyses.
Outcome Title: Change EEG measures after BI-tDCS but not after BI-sham-tDCS
Outcome Description: Assessed by using a 64 channel EEG system. We will evaluate 
absolute spectral power in the frequency range of 4–35 Hz, as we will focus our analysis 
on theta (4–7 Hz), alpha (8–13 Hz), low beta (13-20 Hz) and high beta (20-30 Hz).
Outcome Timeframe: From Visit 1 (before tDCS-BI or before sham-BI) to Visit 12 after10 
study sessions (after tDCS-BI or after sham tDCS-BI).
All other measures not listed in these Endpoints are exploratory and they will be 
examined for change and potentially be considered a primary outcome in the final 
analyses. 
7)
Data Management
The ongoing protection of data and participant privacy is a recognized 
responsibility all project staff having access to this information, the 
Principal Investigator in particular. The following procedures will be 
applied toward the monitoring, management, protection, and integrity of 
data:
1. The electronic data are stored in controlled-access workgroups on secure 
and backed up file servers under the control of the UM Department of 
Information Technology.
2. Access to these workgroups is restricted to project personnel authorized 
by the PI.
3. Each project member has a unique logon ID, knows only his or her 
password, and will have access to data specific to his/her job.
4. Electronically scanned copies of the obtained medical records necessary 
for the establishment of study entry criteria (e.g. SCI diagnosis, etc.) will be 
kept on secure and backed up file servers under the control of the UM 
Department of Information Technology. Hard copies will be returned to the 
participant or destroyed by secure means.
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5. Software databases (MS Access and Excel, IBM SPSS) will not contain 
individually identifiable or other sensitive information. A Subject ID, that 
is NOT based on individually identifiable information will be assigned to 
each participant’s data. 
6. A document linking the Subject ID number to the participant’s identity 
will be under the control of the PI and maintained separately from the raw 
data and scanned medical records. This link will be maintained as long as 
the research or applicable law requires and then destroyed by secure means.
7. Documents with names, social security numbers, or other sensitive 
information (e.g. informed consents, W-9 tax forms, and payment request 
forms) will be maintained separately from research data in locked cabinets 
within the controlled access offices of The Miami Project to Cure Paralysis. 
These documents will be maintained and securely destroyed per UM policy.
8. A UM laptop with UM IT installed encryption may be used by the PI for 
data analysis, however, no individually identifiable data will be located on 
this laptop.
9. Procedures for reporting theft or loss of sensitive data are in place and 
familiar to the study investigators and staff who have access to, use, or store 
data.
Data Analysis: Parametric or non –parametric statistic will be performed 
depending on data distribution.
Risks to Subjects:
Risks/discomforts associated with completion of questionnaires: Some 
questions may be emotionally distressful to some participants or make them 
uncomfortable. Participants will be instructed that they can skip any 
questions which they do not wish to answer.
Risks/discomforts associated with measurement of sensory function 
(QST): Pain thresholds will be measured for cold and hot temperatures. Each 
stimulus trial will start at a neutral temperature (32 ºC) and will be increased 
(for hot pain) until the participant indicates that the stimulus has just become 
painful. This will result in slight discomfort for the participant. As soon as the 
participant tells the experimenter that the stimulus is painful, the stimulus will 
immediately be terminated. Cut-off temperatures are in place (50 ºC for hot 
pain) so that no extreme temperatures will be presented. The cut-off value is 
well below temperatures at which any skin damage would result. The 
equipment used for sensory testing has been used in our laboratory for many 
years, without any adverse events. This equipment is also used in many other 
laboratories and has an excellent track record.
Risks/discomforts associated with BI: bodily illusions are commonly used 
research tools with no risk for participants.
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Risks/discomforts associated with EEG measures: EEG records brain 
activity at no risk to participants. The EEG is used with the only purpose of 
recording, the electrodes are placed on the scalp attached to a custom cap with 
prepared holes. We use an EEG system with active electrodes (Biosemi Active 
Two 64 channels: https://www.biosemi.com/faq/skin_preparation.htm) and so 
high electrode impedance are tolerated, and the system can be used without the 
usual skin preparation (scrubbing) to lower impedance. This minimizes 
discomfort and eliminates risks of infection. In the case of electrodes placed 
around the face, it is possible that participants with very sensitive skin may 
experience redness, however this will be very minor and solve within minutes. 
We use a low impedance highly conductive saline gel (Signa gel by Parker), 
formulated to maximize contact between the body surface and the Active 
electrodes, bacteriostatic, non-irritating, and non-staining.
Risks/discomforts associated with tDCS: the current applied is very weak 
(2mA) and there are not observed serious adverse effects associated with tDCS. 
Minor side effects have included (restricted to the electrode location) mild 
temporary burning or tingling at the site of stimulation, headaches and tiredness 
(Bikson et al., 2016), it is a safe procedure widely used (see (Nitsche et al., 
2003; Poreisz et al., 2007) for more information and safety aspects of tDCS 
use). It should be noted that other side-effects like nausea and dizziness can 
happen and also that they have been illustrated to occur at nearly the same rate 
as sham stimulation (fake stimulation) (Brunoni et al., 2011). These sensations 
are not painful and go away when stimulation stops. When electrodes are 
placed too close to the eye, participants may experience phosphenes that go 
away adjusting the position of electrodes. tDCS it is not a medical device and 
it is considered a non-significant-risk device, meaning that it is a technique 
without expectation of any Serious Adverse Effect (Bikson et al., 2016; 
Fregni et al., 2015). We use standard procedures, which means: no more 
than 2mA of intensity, not more than 40 min per session, with standard 
electrodes (pads) that are typically square 5 × 5 cm or 5 × 7 cm (Bikson et 
al., 2016). It has been extensively used in human research and chronic pain 
(Pinto et al., 2018).
Please note that there is no scientific evidence that suggests lasting injury or 
irreversible side-effects from tDCS, all the minor sides effects are temporary. 
We will explain participants the device and the possible minor side effects and 
we will let them familiarizing for short time by applying a very small amount 
of current before to reach 2mA. 
Adverse Events and Serious Adverse Events associated with electrical 
stimulation: 
temporary skin redness, itching, and tingling. Other suggested but rare side-effects 
of tDCS include headache, nausea, and dizziness. These sensations go away when 
stimulation stops. 
tDCS it is not a medical device and it is considered a non-significant-risk device, meaning 
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that it is a technique without expectation of any Serious Adverse Effect. 
Participants will report to study team if any of these side effects will be experienced, we 
will keep record of any reported side effect.
If the effects are experienced as uncomfortable to participants so that the stimulation will 
need to be stopped, we will not consider any data collected related to those participants. 
Participants have the right to not continue the study, in this case new participants will be 
enrolled for replacement.
8)
Potential Benefits to Subjects
Participants may experience reduction in pain sensation, and will better 
understand their own pain and associated factors. 
9)
Vulnerable Populations
Vulnerable populations, i.e., children, individuals with moderate to severe cognitive 
impairment, prisoners of the penal system, and women who are pregnant will not be 
considered.
10) Setting
The study will take place at The Miami Project to Cure Paralysis, University 
of Miami.
11) Resources Available
Dr. Widerstrom-Noga is the principal investigator of the Clinical Pain 
Research Laboratory of The Miami Project to Cure Paralysis. Her 
educational background is in cross-disciplinary pain research (pain 
physiology and pain psychology) and in the clinical management of chronic 
pain. She have performed human pain research for more than 26 years and 
in the field of spinal cord injury (SCI) for over 22 years. Dr Widerstrom-
Noga has published 65 peer reviewed journal articles and written nine book 
chapters on pain and pain assessment. Her present research involves both 
qualitative and quantitative pain methodologies including quantitative 
sensory testing and MR spectroscopic brain imaging. She has adapted 
outcome measures used to classify and assess pain in other chronic pain 
populations to people with SCI and been instrumental in developing, 
presenting, and promoting the International SCI Pain Data Sets and the 
NINDS CDEs for SCI and Pain. She serves as the Chair or as a member in 
both National and International efforts to standardize pain outcome 
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measures and pain classification, and clinical guidelines related to pain. Dr 
Widerstrom-Noga has extensive interdisciplinary clinical pain research 
experience in persons with neurotrauma, including the use of a wide 
spectrum of pain outcome measurements and pain phenotyping. 
Dr. Vastano is a postdoc at the neurological surgery department at the 
University of Miami, Miller School of Medicine. She as an MSc degree in 
Cognitive and Experimental Psychology and her PhD is in cognitive 
sciences. Her research is focused on understanding brain mechanisms of 
sense of agency (motor control). Her expertise in experimental psychology 
and cognitive neuroscience makes her profile crucial for conducting this 
study. She has several publications on sense agency. In this study Dr. 
Vastano will conduct all measurements as described in the procedures 
section. In Dr. Eva Widerstrom-Noga’s lab, Dr. Vastano has been trained in 
pain research. 
12) Prior Approvals
No prior approvals will be necessary before commencing the study
13) Recruitment Methods
Individuals will be recruited via the Miami Project volunteer database (provided 
monthly by the Director of Education and Outreach at the Miami Project to Cure 
paralysis. The Miami Project research volunteer database is as database of over 
4000 potential and/or current research participants who have expressed an interest 
in being considered for participation our research studies. These participants and 
their responses to an intake form are then screened for eligibility for our current 
research studies) and by word of mouth. In addition, participants will be solicited 
through the website of the Miami Project at the University of Miami (the Miami 
Project has a website and twitter page where they may post our protocols 
information and people can contact us:
 
https://www.themiamiproject.org/participant/research-participation/current-
studies/ ).
Flyers about the study will be placed in the Miami area clinics, physical therapy, 
and rehabilitation centers serving patients with SCI and in University of Miami 
rehabilitation clinics. The research team will be located at the Miami Project to 
Cure Paralysis and available to speak with participants about the study prior 
enrolment, to provide all the information needed.  Potential study participants will 
be asked to contact the study coordinator if they are interested in participating in 
the study and schedule an appointment.
Remuneration: Participants will receive a $250 
$50 after Sensory and Pain examination (QST);  $50 after the first week; $150 at 
the end of the 2 weeks and completed tests.
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14) Local Number of Subjects
The current study is a single site study. We identified a total sample size of 20 SCI 
individuals with neuropathic pain. Additional aspects of sample size determination 
are the type and significance level of the test employed. 
15) Confidentiality
All data obtained in this study will be used solely for research purposes. Sources of research 
material include: 
(1) questionnaires and interviews with the participants regarding pain (paper data); 
(2) reaction times and accuracy (electronic data), as described in the Procedure section. 
Data will be therefore both paper and electronic.
Data will be coded for computer analysis, all participants’ personal information will be 
kept separately by research findings (separation of identifiers and data) during storage, use, 
and transmission:
Personally Identifiable Information: For each participant, a folder will be created that 
contains confidential information. Extensive precautions are taken to insure the privacy of 
participants and the confidentiality of data. Specifically, participant identity is numerically 
coded on all pages within participant folders. All participant folders are kept in confidential 
lockers in our office at the Miami Project to Cure Paralysis . 
The Personally Identifiable Information including name, gender, ethnicity, and relevant 
medical (limited to know if they have pain and if they receive any treatment) and personal 
information (such as address, birth date, telephone number, email address and social 
security number) is kept in a centralized, restricted access location. 
Only personnel directly associated with the study have access to these files.
Data: For each participant, a folder will be created that contains all data. This folder serves 
as a permanent archive of original participant data. Research data will entered into the 
computerized database using only the participant ID number, and without any identifying 
information that would compromise the identity and confidentiality of the participants. 
All electronic data will be secured and password protected in UM servers. 
All paper data and PII will be kept separated and secured in lockers in our office where 
only the research team will have access.
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Choose the statements below that are applicable to this research: 
26(a).  Will the research collect protected health information or personally identifiable 
information from the EMR or from subjects at UHealth and/or JHS?
☐  Yes (If checked go to 26(b))
☒  No (If checked, go to  Section 27)
26(b).  Check the box next to the correct statement below 
☐   Research Subjects will sign a HIPAA Authorization before the research will collect 
this data. 
☐   Research Subjects will not sign a HIPAA Authorization for this data collection and 
the research is requesting a waiver of HIPAA authorization from the IRB.  (If checked, 
complete Section 17 below)
26(c).  How will the research store the data? (See Section 26(e) below)
☐  On a University of Miami electronic device (e.g. encrypted, password-protected 
computer)
☐  On a cloud-based storage system that is approved by the University of Miami 
☐  On the secured JHS SharePoint environment (required for protected health 
information or identifiable information collected from JHS records without a waiver of 
authorization from an IRB.)  
☐  Other, specify:  Click here to enter text.
26(d)  Select one of the following: 
☐  The Principal Investigator (and/or Study Team members) will record (e.g. write 
down, abstract) data acquired in a manner that does not include any indirect or direct 
identifiers (listed in the instructions for Section 26 of this protocol), and the recorded data 
will not be linked to the individual’s’ identity.  
   OR
☐  The Principal investigator (and/or Study Team members) will record (e.g. write 
down, abstract) the data collected in a manner that does not include any direct identifiers 
(see list in the instructions for Section 26 of this protocol) of any subject. Instead, the 
Principal Investigator and/or Study Team members shall will assign a code (that is not 
derived in whole or in part from any direct or indirect identifiers of the individual) to 
each study subject and link the code to the study subject’s identity. The link to each 
subject’s identity and/ or other identifiable information will be maintained on a document 
separate from the research data. 
26(e)  Additional requirement for Jackson Health System Data:
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This section applies to data that will be collected from JHS under a waiver of HIPAA 
authorization (without a signed HIPAA Authorization from the participant). 
X
  Not-applicable, no data will be acquired from JHS under a waiver of authorization. 
  JHS data, including Protected Health Information (PHI) and/or Personally Identifiable 
Information (PII), acquired from JHS for this research under a waiver of authorization shall 
only be stored on the secured JHS SharePoint environment made available by JHS. I and 
the Study Team members shall not copy or store the JHS sourced personally identifiable 
information (PII), including protected health information (PHI) data to any other system, 
including any systems maintained or provided by the University of Miami. I and the Study 
Team shall only copy or transfer JHS-sourced data that has been properly de-identified in 
accordance with all requirements contained in the HIPAA Rules by removing all of the 
identifiers listed in the instructions for Section 26 of this protocol.
16) Provisions to Protect the Privacy Interests of Subjects
See above 5) Data Management.
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17) Consent Process
The consent process will be conducted by Roberta Vastano, Loriann Fleming, Linda 
Robayo Riofrio and/or the PI Dr. Eva Widerstrom-Noga. The consent process will 
take place at The Miami Project to Cure Paralysis, The Christine E. Lynn 
Rehabilitation Center . To ensure candidates have full knowledge of all study 
obligations and potential risks and benefits; all candidates will read the common 
consent document and then have an open, two-way discussion with consenting staff 
to establish 1) that candidates have a full understanding of what their participation 
will entail, and 2) allow the candidates an opportunity to ask questions or express 
concerns and have them fully addressed before proceeding with the study. 
Participants can freely decide to participate taking as much time as needed. The 
research team will follow up by contacting the participant again. This process will be 
present throughout the study and the participant will continue to have access to both 
research staff and the PI to resolve any concern that may arise. The study population 
will be English-speaker since the investigators are English-speakers.
18) Authorization for Use and Disclosure of Protected Health 
Information (HIPAA) 
 If the research team will access patient medical records or other identifiable health 
information for this research, you must obtain a waiver of the requirement for 
written authorization from the patients to access their medical records.  
Type of Request:
 Waiver of Authorization for access to medical record for subject 
identification/recruitment.
 Waiver of Authorization for access to medical record to obtain data for the 
research.
Confirm that you will destroy the Protected Health Information (PHI) you and/or 
your Study Team acquire receive from JHS and/or UHealth at the earliest 
opportunity. 
☐    I confirm 
Confirm that the Protected Health Inform (PHI) you acquire from JHS and/or 
UHealth  will not be re-used or disclosed to any other person or entity, except as 
required by law or for authorized oversight of the research study or for other research 
for which the use or disclosure of PHI is permissible.           
☐     I confirm  
If you are collecting health information from JHS under a waiver of authorization, you 
must read the paragraph below and sign the signature block to indicate your agreement:  
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X
 Not applicable.  This research will not collect data from JHS record under a waiver 
of authorization 
Notwithstanding the preceding “I confirm” statements above, I agree that neither I nor 
any member of the study team listed on the IRB submission for this Protocol shall ever 
re-use or re-disclose any of the information acquired from Jackson Health System in any 
format, whether identifiable or de-identified, to any individual or entity without first 
obtaining written permission from Jackson Health System, even if such re-use or re-
disclosure is permissible by law (e.g., HIPAA).
  
 
______________________________________________
PI Signature                                                               Date
19) Process to Document Consent in Writing
We will document the informed consent process in writing. A member of 
the research team will explain the research study and let participants to read 
the consent form, remaining available for any question and clarification. 
Once participants will understand and sign and date the consent, they  will 
take part of the study. A signed copy of the informed consent will be 
provided to participants as well.
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