Trial Outcomes & Findings for Transcranial Direct Current Stimulation for Post-stroke Motor Recovery (NCT NCT03826030)

NCT ID: NCT03826030

Last Updated: 2025-08-22

Results Overview

The Fugl-Meyer Upper-Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment). FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). The FM-UE scale is a proven scale with excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94 -0.99), and internal consistency (0.97). FM-UE scale was assessed both by site raters (who were masked to the intervention) and by a central rater (who was masked to timepoint and intervention), by watching video recordings. The centrally rated score was used for the primary outcome analysis. For each element of the FM-UE scale, if the centrally rated score could not be determined, the site rater score was substituted.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

Day 15

Results posted on

2025-08-22

Participant Flow

Participant milestones

Participant milestones
Measure
Sham tDCS + mCIMT
Sham tDCS + mCIMT group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
2 mA tDCS + mCIMT
2 mA tDCS + mCIMT group receives direct current stimulation at 2 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
4 mA + mCIMT
4 mA tDCS + mCIMT group receives direct current stimulation at 4 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
Overall Study
STARTED
43
43
43
Overall Study
COMPLETED
39
42
41
Overall Study
NOT COMPLETED
4
1
2

Reasons for withdrawal

Reasons for withdrawal
Measure
Sham tDCS + mCIMT
Sham tDCS + mCIMT group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
2 mA tDCS + mCIMT
2 mA tDCS + mCIMT group receives direct current stimulation at 2 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
4 mA + mCIMT
4 mA tDCS + mCIMT group receives direct current stimulation at 4 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
Overall Study
Withdrawal by Subject
2
0
1
Overall Study
Lost to Follow-up
1
1
1
Overall Study
Too busy to return for visits
1
0
0

Baseline Characteristics

Missing for one participant randomized to Sham tDCS + mCIMT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Sham tDCS + mCIMT
n=43 Participants
Sham tDCS + mCIMT group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
2 mA tDCS + mCIMT
n=43 Participants
2 mA tDCS + mCIMT group receives direct current stimulation at 2 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
4 mA + mCIMT
n=43 Participants
4 mA tDCS + mCIMT group receives direct current stimulation at 4 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
Total
n=129 Participants
Total of all reporting groups
Age, Continuous
56.0 years
n=43 Participants
62.0 years
n=43 Participants
60.0 years
n=43 Participants
59.0 years
n=129 Participants
Sex: Female, Male
Female
22 Participants
n=43 Participants
13 Participants
n=43 Participants
19 Participants
n=43 Participants
54 Participants
n=129 Participants
Sex: Female, Male
Male
21 Participants
n=43 Participants
30 Participants
n=43 Participants
24 Participants
n=43 Participants
75 Participants
n=129 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=43 Participants
3 Participants
n=43 Participants
5 Participants
n=43 Participants
11 Participants
n=129 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
40 Participants
n=43 Participants
40 Participants
n=43 Participants
38 Participants
n=43 Participants
118 Participants
n=129 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=43 Participants
0 Participants
n=43 Participants
0 Participants
n=43 Participants
0 Participants
n=129 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=43 Participants
0 Participants
n=43 Participants
0 Participants
n=43 Participants
0 Participants
n=129 Participants
Race (NIH/OMB)
Asian
0 Participants
n=43 Participants
3 Participants
n=43 Participants
1 Participants
n=43 Participants
4 Participants
n=129 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=43 Participants
0 Participants
n=43 Participants
0 Participants
n=43 Participants
0 Participants
n=129 Participants
Race (NIH/OMB)
Black or African American
20 Participants
n=43 Participants
14 Participants
n=43 Participants
19 Participants
n=43 Participants
53 Participants
n=129 Participants
Race (NIH/OMB)
White
23 Participants
n=43 Participants
25 Participants
n=43 Participants
21 Participants
n=43 Participants
69 Participants
n=129 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=43 Participants
1 Participants
n=43 Participants
0 Participants
n=43 Participants
1 Participants
n=129 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=43 Participants
0 Participants
n=43 Participants
2 Participants
n=43 Participants
2 Participants
n=129 Participants
Time from Index Stroke to Randomization
30-90 Days
11 Participants
n=43 Participants
12 Participants
n=43 Participants
11 Participants
n=43 Participants
34 Participants
n=129 Participants
Time from Index Stroke to Randomization
91-180 Days
32 Participants
n=43 Participants
31 Participants
n=43 Participants
32 Participants
n=43 Participants
95 Participants
n=129 Participants
Pre-Stroke Dominant Side
Left
3 Participants
n=43 Participants
4 Participants
n=43 Participants
3 Participants
n=43 Participants
10 Participants
n=129 Participants
Pre-Stroke Dominant Side
Right
40 Participants
n=43 Participants
39 Participants
n=43 Participants
40 Participants
n=43 Participants
119 Participants
n=129 Participants
Side of the Body Made Weak by the Index Stroke
Left
23 Participants
n=43 Participants
30 Participants
n=43 Participants
17 Participants
n=43 Participants
70 Participants
n=129 Participants
Side of the Body Made Weak by the Index Stroke
Right
20 Participants
n=43 Participants
13 Participants
n=43 Participants
26 Participants
n=43 Participants
59 Participants
n=129 Participants
Pre-Stroke Modified Rankin Scale (mRS)
0: No Symptoms At All
39 Participants
n=43 Participants
35 Participants
n=43 Participants
35 Participants
n=43 Participants
109 Participants
n=129 Participants
Pre-Stroke Modified Rankin Scale (mRS)
1: No Significant Disability Despite Symptoms
1 Participants
n=43 Participants
4 Participants
n=43 Participants
5 Participants
n=43 Participants
10 Participants
n=129 Participants
Pre-Stroke Modified Rankin Scale (mRS)
2: Slight Disability
3 Participants
n=43 Participants
4 Participants
n=43 Participants
3 Participants
n=43 Participants
10 Participants
n=129 Participants
Fugl-Meyer Upper-Extremity (FM-UE) Scale
39.0 units on a scale
n=43 Participants
39.0 units on a scale
n=43 Participants
40.0 units on a scale
n=43 Participants
39.0 units on a scale
n=129 Participants
Montreal Cognitive Assessment (MoCA)
27.0 units on a scale
n=43 Participants
27.0 units on a scale
n=43 Participants
26.0 units on a scale
n=43 Participants
27.0 units on a scale
n=129 Participants
NIH Stroke Scale (NIHSS)
3.0 units on a scale
n=43 Participants
3.0 units on a scale
n=43 Participants
3.0 units on a scale
n=43 Participants
3.0 units on a scale
n=129 Participants
Wolf-Motor Functional Test (WMFT) Time Score
3.9 seconds
n=43 Participants
4.0 seconds
n=43 Participants
3.3 seconds
n=43 Participants
3.8 seconds
n=129 Participants
Log(WMFT Time Score)
1.4 log(seconds)
n=43 Participants
1.4 log(seconds)
n=43 Participants
1.2 log(seconds)
n=43 Participants
1.3 log(seconds)
n=129 Participants
Stroke Impact Scale (SIS) Hand Subscale
25.0 units on a scale
n=43 Participants
30.0 units on a scale
n=43 Participants
30.0 units on a scale
n=43 Participants
25.0 units on a scale
n=129 Participants
Lesion Volume - Affected Side (Centrally Assessed)
1.4 centimeters cubed
n=42 Participants • Missing for one participant randomized to Sham tDCS + mCIMT
2.5 centimeters cubed
n=43 Participants • Missing for one participant randomized to Sham tDCS + mCIMT
1.5 centimeters cubed
n=43 Participants • Missing for one participant randomized to Sham tDCS + mCIMT
1.9 centimeters cubed
n=128 Participants • Missing for one participant randomized to Sham tDCS + mCIMT
Weighted Corticospinal Tract (wCST) Lesion Load - Affected Side (Centrally Assessed)
0.5 centimeters cubed
n=42 Participants • Missing for one subject randomized to Sham tDCS + mCIMT
0.5 centimeters cubed
n=43 Participants • Missing for one subject randomized to Sham tDCS + mCIMT
0.6 centimeters cubed
n=43 Participants • Missing for one subject randomized to Sham tDCS + mCIMT
0.5 centimeters cubed
n=128 Participants • Missing for one subject randomized to Sham tDCS + mCIMT
Presumed Motor Evoked Potential (MEP) Positive - Affected Side
Yes
32 Participants
n=42 Participants • Missing for one subject randomized to Sham tDCS + mCIMT.
31 Participants
n=43 Participants • Missing for one subject randomized to Sham tDCS + mCIMT.
27 Participants
n=43 Participants • Missing for one subject randomized to Sham tDCS + mCIMT.
90 Participants
n=128 Participants • Missing for one subject randomized to Sham tDCS + mCIMT.
Presumed Motor Evoked Potential (MEP) Positive - Affected Side
No
10 Participants
n=42 Participants • Missing for one subject randomized to Sham tDCS + mCIMT.
12 Participants
n=43 Participants • Missing for one subject randomized to Sham tDCS + mCIMT.
16 Participants
n=43 Participants • Missing for one subject randomized to Sham tDCS + mCIMT.
38 Participants
n=128 Participants • Missing for one subject randomized to Sham tDCS + mCIMT.

PRIMARY outcome

Timeframe: Day 15

Population: Modified intent to treat population which included all subjects with any post-baseline data.

The Fugl-Meyer Upper-Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment). FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). The FM-UE scale is a proven scale with excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94 -0.99), and internal consistency (0.97). FM-UE scale was assessed both by site raters (who were masked to the intervention) and by a central rater (who was masked to timepoint and intervention), by watching video recordings. The centrally rated score was used for the primary outcome analysis. For each element of the FM-UE scale, if the centrally rated score could not be determined, the site rater score was substituted.

Outcome measures

Outcome measures
Measure
Sham tDCS + mCIMT
n=41 Participants
Sham tDCS + mCIMT group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
2 mA tDCS + mCIMT
n=43 Participants
2 mA tDCS + mCIMT group receives direct current stimulation at 2 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
4 mA + mCIMT
n=43 Participants
4 mA tDCS + mCIMT group receives direct current stimulation at 4 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
Mean Change in FM-UE From Baseline
4.91 units on a scale
Interval 3.0 to 6.82
3.87 units on a scale
Interval 2.0 to 5.74
5.53 units on a scale
Interval 3.64 to 7.42

SECONDARY outcome

Timeframe: Day 15

The Wolf Motor Function Test (WMFT) is a measure of functional motor activity that quantifies upper extremity (UE) motor ability through timed and functional tasks. The WMFT Time Score the median of 15 timed arm movements and hand dexterity tasks, each to be completed in 120s. If a task could not be completed in 120s, a score of 121s was assigned. A lower WMFT Time Score is better.

Outcome measures

Outcome measures
Measure
Sham tDCS + mCIMT
n=41 Participants
Sham tDCS + mCIMT group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
2 mA tDCS + mCIMT
n=43 Participants
2 mA tDCS + mCIMT group receives direct current stimulation at 2 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
4 mA + mCIMT
n=43 Participants
4 mA tDCS + mCIMT group receives direct current stimulation at 4 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
Mean Change in WMFT Time Score From Baseline
-8.67 score on a scale
Interval -15.5 to -1.84
-1.65 score on a scale
Interval -8.76 to 5.46
-10.37 score on a scale
Interval -18.64 to -2.11

SECONDARY outcome

Timeframe: Day 15

The Stroke Impact Scale (SIS) has 8 subscales which ask questions regarding a patient's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time). The domain/subscale scores, including the SIS Hand Subscale, range from 0 (worst) to 100 (best).

Outcome measures

Outcome measures
Measure
Sham tDCS + mCIMT
n=41 Participants
Sham tDCS + mCIMT group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
2 mA tDCS + mCIMT
n=43 Participants
2 mA tDCS + mCIMT group receives direct current stimulation at 2 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
4 mA + mCIMT
n=43 Participants
4 mA tDCS + mCIMT group receives direct current stimulation at 4 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
Mean Change in SIS Hand Subscale From Baseline
25.24 score on a scale
Interval 19.13 to 31.36
13.60 score on a scale
Interval 8.01 to 19.2
21.51 score on a scale
Interval 15.77 to 27.25

Adverse Events

Sham tDCS + mCIMT

Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths

2 mA tDCS + mCIMT

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

4 mA + mCIMT

Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Sham tDCS + mCIMT
n=43 participants at risk
Sham tDCS + mCIMT group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
2 mA tDCS + mCIMT
n=43 participants at risk
2 mA tDCS + mCIMT group receives direct current stimulation at 2 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
4 mA + mCIMT
n=43 participants at risk
4 mA tDCS + mCIMT group receives direct current stimulation at 4 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
Cardiac disorders
Myocardial infarction
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
2.3%
1/43 • Number of events 1 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
2.3%
1/43 • Number of events 1 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
Injury, poisoning and procedural complications
Fall
2.3%
1/43 • Number of events 1 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
2.3%
1/43 • Number of events 1 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
Nervous system disorders
Carotid artery stenosis
2.3%
1/43 • Number of events 1 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
Nervous system disorders
Ischaemic stroke
2.3%
1/43 • Number of events 1 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
2.3%
1/43 • Number of events 1 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
Reproductive system and breast disorders
Vaginal haemorrhage
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
2.3%
1/43 • Number of events 1 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
Cardiac disorders
Cardiac failure acute
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
2.3%
1/43 • Number of events 1 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).

Other adverse events

Other adverse events
Measure
Sham tDCS + mCIMT
n=43 participants at risk
Sham tDCS + mCIMT group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
2 mA tDCS + mCIMT
n=43 participants at risk
2 mA tDCS + mCIMT group receives direct current stimulation at 2 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
4 mA + mCIMT
n=43 participants at risk
4 mA tDCS + mCIMT group receives direct current stimulation at 4 mA for 30 minutes per session. All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session.
General disorders
Fatigue
2.3%
1/43 • Number of events 3 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
2.3%
1/43 • Number of events 1 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
7.0%
3/43 • Number of events 3 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
Injury, poisoning and procedural complications
Fall
7.0%
3/43 • Number of events 3 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
0.00%
0/43 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).
4.7%
2/43 • Number of events 2 • Up to 105 days after randomization
Reportable adverse events (AE) included: all serious AEs, any AEs that occur during the intervention period, any AEs that are possibly or definitely related to the intervention regardless of when they occur, and all clinically important adverse safety events including: severe headache, second-degree skin burn, clinical seizure, and neurological deterioration (greater than or equal to 4 point increase in NIHSS).

Additional Information

Wayne Feng, MD

Duke University

Phone: 919-681-1700

Results disclosure agreements

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