Trial Outcomes & Findings for Improving SCI Rehabilitation Interventions by Retraining the Brain (NCT NCT03892746)

NCT ID: NCT03892746

Last Updated: 2025-12-10

Results Overview

UEMS is used in Spinal Cord injury to identify strength (muscle power) in patients with spinal cord injury. It involves a manual muscle test of five key muscles in each arm graded from 0 (no contraction) to 5 (normal strength). Each Arm can have a max score of 25 and the total score for the test is 50 points. The higher the value the more muscle strength the participant has and a higher change score means more improvement. The sum of scores for both arms is reported here.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 47 participants
• Primary outcome timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)
• Results posted on: 2025-12-10

Participant Flow

All spinal cord injury (SCI) participants were enrolled in the study between July 2019 and August 2024. Enrollment sites included the Cleveland Clinic, Louis Stokes Cleveland VA Medical Center, Kessler Institute for Rehabilitation, and MetroHealth Hospital. Following the provision of informed consent, participants underwent an eligibility assessment to confirm study qualifications were met.

Of the 47 enrolled SCI participants, six were excluded prior to group assignment. Reasons for exclusion include voluntarily withdrawal (5) and unable to proceed due to clinical care requirements (1). The remaining 41 participants were randomized and competed study procedures.

Participant milestones

Measure	Active tDCS + Task Oriented Practice Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.
Overall Study STARTED	20	21
Overall Study COMPLETED	16	20
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	Active tDCS + Task Oriented Practice Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Improving SCI Rehabilitation Interventions by Retraining the Brain

Baseline characteristics by cohort

Measure	Active tDCS + Task Oriented Practice n=20 Participants Active tDCS + task oriented practice: Participants in this arm will receive active tDCS(2mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice n=21 Participants Sham tDCS + task oriented practice: Participants in this arm will receive sham tDCS(0mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks	Total n=41 Participants Total of all reporting groups
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=681 Participants
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=681 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=4 Participants	17 Participants n=50 Participants	35 Participants n=681 Participants
Age, Categorical >=65 years	2 Participants n=4 Participants	4 Participants n=50 Participants	6 Participants n=681 Participants
Age, Continuous	48 years STANDARD_DEVIATION 16 • n=4 Participants	48 years STANDARD_DEVIATION 17 • n=50 Participants	48 years STANDARD_DEVIATION 16 • n=681 Participants
Sex: Female, Male Female	3 Participants n=4 Participants	2 Participants n=50 Participants	5 Participants n=681 Participants
Sex: Female, Male Male	17 Participants n=4 Participants	19 Participants n=50 Participants	36 Participants n=681 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=4 Participants	1 Participants n=50 Participants	1 Participants n=681 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=4 Participants	20 Participants n=50 Participants	40 Participants n=681 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=681 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=681 Participants
Race (NIH/OMB) Asian	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=681 Participants
Race (NIH/OMB) Black or African American	5 Participants n=4 Participants	5 Participants n=50 Participants	10 Participants n=681 Participants
Race (NIH/OMB) White	15 Participants n=4 Participants	14 Participants n=50 Participants	29 Participants n=681 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=50 Participants	0 Participants n=681 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	2 Participants n=50 Participants	2 Participants n=681 Participants
Region of Enrollment United States	20 participants n=4 Participants	21 participants n=50 Participants	41 participants n=681 Participants

PRIMARY outcome

Timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)

UEMS is used in Spinal Cord injury to identify strength (muscle power) in patients with spinal cord injury. It involves a manual muscle test of five key muscles in each arm graded from 0 (no contraction) to 5 (normal strength). Each Arm can have a max score of 25 and the total score for the test is 50 points. The higher the value the more muscle strength the participant has and a higher change score means more improvement. The sum of scores for both arms is reported here.

Outcome measures

Measure	Active tDCS + Task Oriented Practice n=16 Participants Active tDCS + task oriented practice: Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice n=20 Participants Sham tDCS + task oriented practice: Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.
Change in Upper Extremity Motor Score (UEMS) With Manual Muscle Testing	3.5 score on a scale Standard Error 0.67	2.55 score on a scale Standard Error .67

PRIMARY outcome

Timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)

Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) is a functional measure which identifies the functional ability of the upper limbs and is widely used in studies recruiting Spinal Cord Injury patients. It has subsets including strength (100 points total, 50 per arm), palmar and dorsal sensation (48 points total, 24 per arm), prehension ability (24 points total, 12 per arm), and prehension performance (60 points total, 30 per arm). The higher the score the better the performance. The greater the change in score the more the participant improved. The sum of scores for both arms is reported here.

Outcome measures

Measure	Active tDCS + Task Oriented Practice n=16 Participants Active tDCS + task oriented practice: Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice n=20 Participants Sham tDCS + task oriented practice: Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.
Change in Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)	9.56 units on a scale Standard Error 2.96	10.3 units on a scale Standard Error 1.74

PRIMARY outcome

Timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)

The Canadian Occupational Performance Measure (COPM) is an evidence-based outcome measure designed to capture the participants self-perception of everyday issues that restrict their participation in everyday living, measuring both their performance in completing the identified task and their satisfaction in their performance of the task. Here we report the performance scale of the assessment. The score range is from minimum 1 (not able to do it at all) and maximum 10 (able to do it extremely well). A larger change score indicates more subjective improvement in performance of activies of daily living.

Outcome measures

Measure	Active tDCS + Task Oriented Practice n=16 Participants Active tDCS + task oriented practice: Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice n=20 Participants Sham tDCS + task oriented practice: Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.
Change in Canadian Occupational Performance Measure (COPM) Performance	0.89 score on a scale Standard Error 0.22	0.77 score on a scale Standard Error 0.33

PRIMARY outcome

Timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)

The Canadian Occupational Performance Measure (COPM) is an evidence-based outcome measure designed to capture the participants self-perception of everyday issues that restrict their participation in everyday living, measuring both their performance in completing the identified task and their satisfaction in their performance of the task. Here we report the satisfaction scale of the assessment. The score range is from minimum 1 (not satisfied at all) and maximum 10 (extremely satisfied). A larger change score indicates more subjective improvement in satisfaction of completing activies of daily living.

Outcome measures

Measure	Active tDCS + Task Oriented Practice n=16 Participants Active tDCS + task oriented practice: Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice n=20 Participants Sham tDCS + task oriented practice: Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.
Change in Canadian Occupational Performance Measure (COPM) Satisfaction	0.92 score on a scale Standard Error 0.25	1.36 score on a scale Standard Error 0.37

PRIMARY outcome

Timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)

The Spinal Cord Indepence Measure (SCIM) is a participant subjective spinal cord injury measure that identifies daily acitivity indepence. The Self-care subscore of the SCIM looks at independence in performing daily activies and ranges from minimum 0 (total dependence in self-care) to maximum 20 (complete independence in self-care). A higher change score indicates improved levels of independece for the participant.

Outcome measures

Measure	Active tDCS + Task Oriented Practice n=16 Participants Active tDCS + task oriented practice: Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice n=20 Participants Sham tDCS + task oriented practice: Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.
Change in Spinal Cord Independence Measure (SCIM), Self-care Subscore	0.62 score on a scale Standard Error 0.38	0.3 score on a scale Standard Error 0.44

PRIMARY outcome

Timeframe: Baseline (0 weeks), after intervention (up to 8 weeks)

The Capabilities of Upper Extremity Test (CUE-T) is a performance based functional measure that evaluates upper extremity function in poeple with cervical spinal cord injury. It consists of 32 items, each item is scored from 0 (unable to complete task) to 4 (no difficulty to complete task). The minimum score of the scale is 0 (unable to performe any of the tasks) to maximum 128 (able to complete every task with no difficulty). A higher change score indicates and improvement in ability to complete upper limb functional tasks.

Outcome measures

Measure	Active tDCS + Task Oriented Practice n=16 Participants Active tDCS + task oriented practice: Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice n=20 Participants Sham tDCS + task oriented practice: Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.
Change in Capabilities of Upper Extremity Test (CUE-T)	3.44 score on a scale Standard Error 1.26	3.75 score on a scale Standard Error 0.93

PRIMARY outcome

Timeframe: Baseline (0 weeks) and after intervention (up to 8 weeks)

Population: Three participants (2 active, 1 sham) were excluded from the analysis as they did not complete both pre and post testing due to voluntarily opting out of undergoing the neurophysiology testing session.

Transcranial magnetic stimulation was used to test cortical and corticospinal physiology. The active motor threshold (AMT) is the lowest intensity of stimulation needed to produce a motor evoked potential during a voluntary contraction in the biceps muscle. The criteria for defining a motor evoked potential is 6 out of 10 trials in which the response signal is larger peak-to-peak than the background muscle activity by 100µV. The AMT can have a value ranging from 0-100, an indicator of the percentage of the maximum stimulator output (MSO). The higher the value the more stimulation intensity needed to get a criterion motor evoked potential in the target muscle; lower AMT values indicate higher excitability in the muscle. A change score that is negative indicates increased excitability in the biceps muscle.

Outcome measures

Measure	Active tDCS + Task Oriented Practice n=14 Participants Active tDCS + task oriented practice: Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice n=19 Participants Sham tDCS + task oriented practice: Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.
Change in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm-Biceps	1.1 Percentage of MSO Standard Error 3.4	-0.9 Percentage of MSO Standard Error 1.1

PRIMARY outcome

Timeframe: Baseline (0 weeks) and after intervention (up to 8 weeks)

Population: One participant (1 active) was excluded from the analysis as they did not complete both pre and post testing due to voluntarily opting out of undergoing the neurophysiology testing session.

Transcranial magnetic stimulation was used to test cortical and corticospinal physiology. The active motor threshold (AMT) is the lowest intensity of stimulation needed to produce a motor evoked potential during a voluntary contraction in the triceps muscle. The criteria for defining a motor evoked potential is 6 out of 10 trials in which the response signal is larger peak-to-peak than the background muscle activity by 100µV. The AMT can have a value ranging from 0-100, an indicator of the percentage of the maximum stimulator output (MSO). The higher the value, the more stimulation intensity needed to get a criterion motor evoked potential in the target muscle; lower AMT values indicate higher excitability in the muscle. A change score that is negative indicates increased excitability in the triceps muscle.

Outcome measures

Measure	Active tDCS + Task Oriented Practice n=15 Participants Active tDCS + task oriented practice: Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice n=20 Participants Sham tDCS + task oriented practice: Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.
Change in Excitability (Active Motor Threshold) of Cortical and Corticospinal Physiology (TMS), Weaker Arm Triceps	0.1 Percentage of MSO Standard Error 1.1	-2.2 Percentage of MSO Standard Error 2.9

PRIMARY outcome

Timeframe: Baseline (0 weeks) and after intervention (up to 8 weeks)

Population: Peripheral nerve stimulation in SCI participants can be painful due to heightened sensitivity. Also due to limitations of stimulator output we may not have seen a signal to analyze. Therefore only 6 participants in the active group and 10 participants in the sham group had eligible data to analyze from baseline to post test

Spinal pathways were tested using peripheral nerve stimulation to median nerve to collect responses in the Flexor Carpi Radialis muscle of the weaker arm. This stimulation stimulates both the sensory and motor nerves to produce a evoked potential for each pathway. The evoked potential produced for the sensory pathway is considered the Hoffman reflex (H-reflex) and the evoked potential produced for the motor pathway is considered the muscle compund action potential (M-wave). To get an understanding of the motor neuron pool of exitability we use the H/M ratio which compares the peak amplitude of the maximum H-reflex to the maximum M-wave (H-reflex/M-wave). This ratio reflects the proportion of the motor neruon pool activated by the reflex or motor neuron excitability. A lower H/M ratio generally indicates lower excitability while a higher ratio indicates higher excitability.

Outcome measures

Measure	Active tDCS + Task Oriented Practice n=6 Participants Active tDCS + task oriented practice: Participants in this arm will receive active tDCS (2mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice n=10 Participants Sham tDCS + task oriented practice: Participants in this arm will receive sham tDCS (0mA) to the motor cortex (targeting the triceps) of the weaker upper limb for 2, 30-minute cycles during each 2-hour upper limb training session. While receiving tDCS, the participant will be performing task-oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.
Change in Excitability of Spinal Physiology of the Flexor Carpi Radialis Muslce in the Weaker Arm.	-5.1 change in H/M ratio Standard Error 4.7	-0.7 change in H/M ratio Standard Error 4.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, an average of 7 months

In line with this phase I/II clinical trial, safety and feasibility will be tested throughout this study. Vital signs (blood pressure, heart rate, respirations, blood oxygen saturation) will be recorded for each study session. During Intervention sessions we will ask a tDCS adverse effects questionnaire at the end of each session.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (0 weeks) and after intervention (up to 8 weeks)

A TMS safety questionnaire will be asked at the end of the preintervention tests and the post intervention testing visit.

Outcome measures

Outcome data not reported

Adverse Events

Active tDCS + Task Oriented Practice

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Sham tDCS + Task Oriented Practice

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active tDCS + Task Oriented Practice n=20 participants at risk Active tDCS + task oriented practice: Participants in this arm will receive active tDCS(2mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks.	Sham tDCS + Task Oriented Practice n=21 participants at risk Sham tDCS + task oriented practice: Participants in this arm will receive sham tDCS(0mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 15 sessions over several weeks up to 8 weeks
Skin and subcutaneous tissue disorders Pain at the site of stimulation	15.0% 3/20 • Through study completion, an average of 7 months	19.0% 4/21 • Through study completion, an average of 7 months
Nervous system disorders Headache	30.0% 6/20 • Through study completion, an average of 7 months	19.0% 4/21 • Through study completion, an average of 7 months
Nervous system disorders Difficulties in concentrating	5.0% 1/20 • Through study completion, an average of 7 months	9.5% 2/21 • Through study completion, an average of 7 months
Nervous system disorders Visual sensations associated with stimulation	10.0% 2/20 • Through study completion, an average of 7 months	0.00% 0/21 • Through study completion, an average of 7 months
Social circumstances Nervousness	5.0% 1/20 • Through study completion, an average of 7 months	4.8% 1/21 • Through study completion, an average of 7 months
Skin and subcutaneous tissue disorders Redness at Site of Stimulation	20.0% 4/20 • Through study completion, an average of 7 months	33.3% 7/21 • Through study completion, an average of 7 months
Nervous system disorders Dizziness	0.00% 0/20 • Through study completion, an average of 7 months	4.8% 1/21 • Through study completion, an average of 7 months
Nervous system disorders Disorientation/Confusion	0.00% 0/20 • Through study completion, an average of 7 months	4.8% 1/21 • Through study completion, an average of 7 months
Skin and subcutaneous tissue disorders Tingling Sensation	80.0% 16/20 • Through study completion, an average of 7 months	71.4% 15/21 • Through study completion, an average of 7 months
Skin and subcutaneous tissue disorders Itching Sensation	70.0% 14/20 • Through study completion, an average of 7 months	47.6% 10/21 • Through study completion, an average of 7 months
Skin and subcutaneous tissue disorders Burning Sensation	65.0% 13/20 • Through study completion, an average of 7 months	66.7% 14/21 • Through study completion, an average of 7 months

Additional Information

Ela Plow, Associate Professor

Cleveland Clinic

Phone: 216-445-4589

Email: plowe2@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place