Trial Outcomes & Findings for Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery (NCT NCT01007136)

NCT ID: NCT01007136

Last Updated: 2020-09-22

Results Overview

Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2020-09-22

Participant Flow

UT SOuthwestern Hospitals, rehabilitation and stroke clinics were screened for eligible stroke patients from 2009 through 2014.

Enrolled participants were assigned to groups unless they were found to meet one of the exclusion criteria, or withdrew their consent.

Participant milestones

Measure	tDCS and Occupational Therapy 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and Occupational Therapy Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	fMRI Control Group no Intervention Healthy volunteers and chronic stroke volunteers were enrolled in the fMRI and TMS component of the study, no intervention was performed.The purpose of this study subgroup was to set up and test the complex MRI and TMS protocol developed for this project.	tDCS and no Arm Movement 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and no Arm Movement Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Overall Study STARTED	19	17	15	6	4
Overall Study COMPLETED	15	13	15	6	4
Overall Study NOT COMPLETED	4	4	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

Baseline characteristics by cohort

Measure	tDCS and Occupational Therapy n=19 Participants 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and Occupational Therapy n=17 Participants Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	fMRI Control Group no Intervention n=15 Participants Healthy volunteers and chronic stroke volunteers were enrolled in the fMRI and TMS component of the study, no intervention was performed.	tDCS and no Arm Movement n=6 Participants 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and no Arm Movement n=4 Participants Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	42 Participants n=10 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	19 Participants n=10 Participants
Age, Continuous	62.5 years STANDARD_DEVIATION 11.3 • n=5 Participants	60.7 years STANDARD_DEVIATION 10.3 • n=7 Participants	49 years STANDARD_DEVIATION 13 • n=5 Participants	66 years STANDARD_DEVIATION 10 • n=4 Participants	63.5 years STANDARD_DEVIATION 8.3 • n=21 Participants	59 years STANDARD_DEVIATION 13 • n=10 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	32 Participants n=10 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	29 Participants n=10 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: All subjects with outcome data at the prespecified follow-up timepoint were included. "fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.

Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.

Outcome measures

Measure	tDCS and Occupational Therapy n=15 Participants 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and Occupational Therapy n=13 Participants Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	tDCS and no Arm Movement n=6 Participants 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and no Arm Movement n=4 Participants Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Upper Extremity Fugl-Meyer	30.2 units on a scale Standard Deviation 21.2	36.8 units on a scale Standard Deviation 22.4	8.2 units on a scale Standard Deviation 10.2	4.5 units on a scale Standard Deviation 1

PRIMARY outcome

Timeframe: 3 months

Population: All subjects with outcome data at the prespecified follow-up timepoint were included. "fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.

Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.

Outcome measures

Measure	tDCS and Occupational Therapy n=10 Participants 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and Occupational Therapy n=11 Participants Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	tDCS and no Arm Movement n=3 Participants 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and no Arm Movement n=1 Participants Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Upper Extremity Fugl-Meyer	32.4 units on a scale Standard Deviation 24.5	47.7 units on a scale Standard Deviation 18.7	9.7 units on a scale Standard Deviation 9.8	4.0 units on a scale Standard Deviation 0.0

PRIMARY outcome

Timeframe: 1 year after stroke

Population: All subjects with outcome data at the prespecified follow-up timepoint were included.

Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.

Outcome measures

Measure	tDCS and Occupational Therapy n=5 Participants 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and Occupational Therapy n=9 Participants Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	tDCS and no Arm Movement 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and no Arm Movement n=1 Participants Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Upper Extremity Fugl-Meyer	32.6 units on a scale Standard Deviation 29.2	56.0 units on a scale Standard Deviation 12.8	—	4.0 units on a scale Standard Deviation 0.0

SECONDARY outcome

Timeframe: 3 months

Population: All subjects with outcome data at the prespecified follow-up timepoint were included. "fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.

The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability determined through the use of timed and functional tasks. The score represents the average speed the subject could perform of the timed motor tasks.

The score is the average of the scores calculated from "how many times would a person have completed the task, had he or she been performing it continuously for 60 seconds". The score ranges from 0 to no theoretical maximum, with higher numbers meaning faster/ better performance. (See publication Dr. Hodics et al. 2012.)

Outcome measures

Measure	tDCS and Occupational Therapy n=10 Participants 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and Occupational Therapy n=11 Participants Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	tDCS and no Arm Movement n=2 Participants 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and no Arm Movement n=1 Participants Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Wolf Motor Function Test	19.7 units on a scale Standard Deviation 19.6	30.9 units on a scale Standard Deviation 21.7	0.80 units on a scale Standard Deviation 1.12	0.79 units on a scale Standard Deviation 0.00

OTHER_PRE_SPECIFIED outcome

Timeframe: during therapy

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.

Mini Mental Status Scale is a test of cognitive function; it includes tests of orientation, attention, memory, language and visual-spatial skills, scored 0-30, the higher scores mean the better performance.

Outcome measures

Measure	tDCS and Occupational Therapy n=10 Participants 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and Occupational Therapy n=11 Participants Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	tDCS and no Arm Movement n=3 Participants 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and no Arm Movement n=1 Participants Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Mini Mental Status Scale	24.7 score on a scale Standard Deviation 6.6	26.6 score on a scale Standard Deviation 4.8	27.3 score on a scale Standard Deviation 3.8	30.0 score on a scale Standard Deviation 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: All available data from participants was included at the 3 months follow-up. fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.

The National Institutes of Health Stroke Scale (NIHSS) provides a quantitative measure of stroke-related neurologic deficit. The NIHSS was originally designed as a research tool to measure baseline data on patients in acute stroke clinical trials. The score ranges 0-42, a score of 0 represents no deficit, lower score is better.

Outcome measures

Measure	tDCS and Occupational Therapy n=10 Participants 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and Occupational Therapy n=11 Participants Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	tDCS and no Arm Movement n=2 Participants 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and no Arm Movement n=1 Participants Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
NIHSS	3.50 units on a scale Standard Deviation 3.06	1.45 units on a scale Standard Deviation 1.57	7.00 units on a scale Standard Deviation 1.00	6.00 units on a scale Standard Deviation 0.00

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: All participants with available measurement were included. fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.

21-item, self-rated scale that evaluates key symptoms of depression. The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity.

Outcome measures

Measure	tDCS and Occupational Therapy n=10 Participants 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and Occupational Therapy n=11 Participants Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	tDCS and no Arm Movement n=2 Participants 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and no Arm Movement n=1 Participants Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Beck Depression Inventory	3.2 units on a scale Standard Deviation 2.9	5.0 units on a scale Standard Deviation 4.5	5.50 units on a scale Standard Deviation 3.54	3.00 units on a scale Standard Deviation 0.00

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Population: All participants with available data were included. fMRI Control Group no Intervention" subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.

The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living. Ten variables describing activities of daily living and mobility are scored. The total score ranges 0-100, a higher number being a reflection of greater ability to function independently following hospital discharge.

Outcome measures

Measure	tDCS and Occupational Therapy n=7 Participants 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and Occupational Therapy n=6 Participants Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	tDCS and no Arm Movement n=2 Participants 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and no Arm Movement n=1 Participants Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Barthel Index	66.4 score on a scale Standard Deviation 12.1	82.5 score on a scale Standard Deviation 16.0	57.5 score on a scale Standard Deviation 10.6	50.0 score on a scale Standard Deviation 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

The muscle scale grades muscle strength on a scale of 0 to 5 in relation to the maximum expected for that muscle. The patient's effort is graded on a scale of 0 (no movement) -5 (muscle contracts normally against full resistance).

Outcome measures

Outcome data not reported

Adverse Events

tDCS and Occupational Therapy

Serious events: 2 serious events

Other events: 9 other events

Deaths: 1 deaths

Sham and Occupational Therapy

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

fMRI Control Group no Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

tDCS and no Arm Movement

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sham and no Arm Movement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	tDCS and Occupational Therapy n=19 participants at risk 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and Occupational Therapy n=17 participants at risk Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	fMRI Control Group no Intervention n=15 participants at risk Healthy volunteers and chronic stroke volunteers were enrolled in the fMRI and TMS component of the study, no intervention was performed.	tDCS and no Arm Movement n=6 participants at risk 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and no Arm Movement n=4 participants at risk Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Nervous system disorders recurrent stroke	0.00% 0/19 • 1 year, the entire time of follow-up.	5.9% 1/17 • Number of events 1 • 1 year, the entire time of follow-up.	0.00% 0/15 • 1 year, the entire time of follow-up.	0.00% 0/6 • 1 year, the entire time of follow-up.	0.00% 0/4 • 1 year, the entire time of follow-up.
Infections and infestations death	5.3% 1/19 • Number of events 1 • 1 year, the entire time of follow-up.	0.00% 0/17 • 1 year, the entire time of follow-up.	0.00% 0/15 • 1 year, the entire time of follow-up.	0.00% 0/6 • 1 year, the entire time of follow-up.	0.00% 0/4 • 1 year, the entire time of follow-up.
Nervous system disorders mental status change hospitalisation	5.3% 1/19 • Number of events 1 • 1 year, the entire time of follow-up.	0.00% 0/17 • 1 year, the entire time of follow-up.	0.00% 0/15 • 1 year, the entire time of follow-up.	0.00% 0/6 • 1 year, the entire time of follow-up.	0.00% 0/4 • 1 year, the entire time of follow-up.
Musculoskeletal and connective tissue disorders hip fracture	0.00% 0/19 • 1 year, the entire time of follow-up.	5.9% 1/17 • Number of events 1 • 1 year, the entire time of follow-up.	0.00% 0/15 • 1 year, the entire time of follow-up.	0.00% 0/6 • 1 year, the entire time of follow-up.	0.00% 0/4 • 1 year, the entire time of follow-up.

Other adverse events

Measure	tDCS and Occupational Therapy n=19 participants at risk 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and Occupational Therapy n=17 participants at risk Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	fMRI Control Group no Intervention n=15 participants at risk Healthy volunteers and chronic stroke volunteers were enrolled in the fMRI and TMS component of the study, no intervention was performed.	tDCS and no Arm Movement n=6 participants at risk 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment. tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Sham and no Arm Movement n=4 participants at risk Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Nervous system disorders phosphene phenomenon	21.1% 4/19 • 1 year, the entire time of follow-up.	0.00% 0/17 • 1 year, the entire time of follow-up.	0.00% 0/15 • 1 year, the entire time of follow-up.	33.3% 2/6 • 1 year, the entire time of follow-up.	0.00% 0/4 • 1 year, the entire time of follow-up.
Product Issues itching or tingtling under the electrode	26.3% 5/19 • 1 year, the entire time of follow-up.	5.9% 1/17 • 1 year, the entire time of follow-up.	0.00% 0/15 • 1 year, the entire time of follow-up.	0.00% 0/6 • 1 year, the entire time of follow-up.	0.00% 0/4 • 1 year, the entire time of follow-up.
Gastrointestinal disorders vomiting	5.3% 1/19 • 1 year, the entire time of follow-up.	5.9% 1/17 • 1 year, the entire time of follow-up.	0.00% 0/15 • 1 year, the entire time of follow-up.	0.00% 0/6 • 1 year, the entire time of follow-up.	0.00% 0/4 • 1 year, the entire time of follow-up.
Nervous system disorders sleepiness	5.3% 1/19 • 1 year, the entire time of follow-up.	0.00% 0/17 • 1 year, the entire time of follow-up.	0.00% 0/15 • 1 year, the entire time of follow-up.	0.00% 0/6 • 1 year, the entire time of follow-up.	0.00% 0/4 • 1 year, the entire time of follow-up.
Skin and subcutaneous tissue disorders car accident	0.00% 0/19 • 1 year, the entire time of follow-up.	5.9% 1/17 • 1 year, the entire time of follow-up.	0.00% 0/15 • 1 year, the entire time of follow-up.	0.00% 0/6 • 1 year, the entire time of follow-up.	0.00% 0/4 • 1 year, the entire time of follow-up.

Additional Information

Timea Hodics, M.D.

University of Texas Southwestern

Email: Timea.Hodics@UTSouthwestern.edu

Results disclosure agreements

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