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.
COMPLETED
PHASE2
129 participants
Day 15
2025-08-22
Participant Flow
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
| 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
| 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 15Population: 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
| 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 15The 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
| 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 15The 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
| 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
2 mA tDCS + mCIMT
4 mA + mCIMT
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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place