Trial Outcomes & Findings for Robots Paired With tDCS in Stroke Recovery (NCT NCT01726673)
NCT ID: NCT01726673
Last Updated: 2021-05-14
Results Overview
The median change in Upper Extremity Fugl-Meyer Score was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.
COMPLETED
PHASE2
54 participants
baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)
2021-05-14
Participant Flow
Subjects were randomized to receive 36 sessions of either active tDCS immediately followed by robotic arm therapy or sham tDCS immediately followed by robotic arm therapy.
Participant milestones
| Measure |
tDCS + Robotic Arm Therapy
Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)
Transcranial Direct Current Stimulation (tDCS)
|
tDCS Sham + Robotic Arm Therapy
Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).
Placebo sham
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
24
|
|
Overall Study
COMPLETED
|
24
|
21
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Robots Paired With tDCS in Stroke Recovery
Baseline characteristics by cohort
| Measure |
tDCS + Robotic Arm Therapy
n=30 Participants
Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)
Transcranial Direct Current Stimulation (tDCS)
|
tDCS Sham + Robotic Arm Therapy
n=24 Participants
Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)
Placebo sham
|
Total
n=54 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
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)Population: 45 patients completed 36 sessions (3x/week for 12 weeks) of robotic arm training + sham or active tDCS, and 6 month follow-up at 36 weeks. These 45 participants were consequently included in the efficacy analysis.
The median change in Upper Extremity Fugl-Meyer Score was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.
Outcome measures
| Measure |
tDCS + Robotic Arm Therapy
n=24 Participants
Active Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)
Transcranial Direct Current Stimulation (tDCS)
|
tDCS Sham + Robotic Arm Therapy
n=21 Participants
Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).
Placebo sham
|
|---|---|---|
|
Median Change in Upper Extremity Fugl Meyer Assessment Score
Median change from baseline to discharge at 12 wks
|
4.5 scores on a scale
Interval 3.0 to 8.0
|
6.0 scores on a scale
Interval 4.0 to 8.0
|
|
Median Change in Upper Extremity Fugl Meyer Assessment Score
Median change from baseline to 6 month follow-up
|
4 scores on a scale
Interval 2.0 to 7.0
|
6 scores on a scale
Interval 4.0 to 7.25
|
SECONDARY outcome
Timeframe: baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)Population: 45 patients completed 36 sessions (3x/week for 12 weeks) of robotic arm training + sham or active tDCS, and 6 month follow-up at 36 weeks. These 45 participants were consequently included in the efficacy analysis.
The median change in performance time for the WOLF motor function test was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total WOLF motor function timed score is reported here in seconds, with a range 0-1800 seconds, and with lower values indicating faster completion of task and better functional status.
Outcome measures
| Measure |
tDCS + Robotic Arm Therapy
n=24 Participants
Active Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)
Transcranial Direct Current Stimulation (tDCS)
|
tDCS Sham + Robotic Arm Therapy
n=21 Participants
Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).
Placebo sham
|
|---|---|---|
|
Median Change in WOLF Motor Function Test (WMFT)
Median change from baseline to discharge at 12 wks
|
-34 seconds
Interval -235.25 to 0.0
|
-19 seconds
Interval -157.0 to -1.5
|
|
Median Change in WOLF Motor Function Test (WMFT)
Median change from baseline to 6 month follow-up
|
-103 seconds
Interval -245.5 to -5.0
|
-81.5 seconds
Interval -260.5 to 0.0
|
SECONDARY outcome
Timeframe: 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention)Population: 45 patients completed 36 sessions (3x/week for 12 weeks) of robotic arm training + sham or active tDCS, and 6 month follow-up at 36 weeks. These 45 participants were consequently included in the efficacy analysis.
The median change in Motor Power Manual Muscle Test Score for the upper extremity was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Motor Power Manual Muscle Test Score is reported here, with a range 0-100 points, and with higher values indicating better functional status.
Outcome measures
| Measure |
tDCS + Robotic Arm Therapy
n=24 Participants
Active Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)
Transcranial Direct Current Stimulation (tDCS)
|
tDCS Sham + Robotic Arm Therapy
n=21 Participants
Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).
Placebo sham
|
|---|---|---|
|
Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC)
Median change from baseline to discharge at 12 wks
|
7 scores on a scale
Interval 4.0 to 9.5
|
7 scores on a scale
Interval 5.0 to 8.0
|
|
Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC)
Median change from baseline to 6 month follow-up
|
6 scores on a scale
Interval 3.0 to 11.25
|
6 scores on a scale
Interval 4.0 to 9.0
|
Adverse Events
tDCS + Robotic Arm Therapy
tDCS Sham + Robotic Arm Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
tDCS + Robotic Arm Therapy
n=30 participants at risk
Active Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total)
Transcranial Direct Current Stimulation (tDCS)
|
tDCS Sham + Robotic Arm Therapy
n=24 participants at risk
Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total).
Placebo sham
|
|---|---|---|
|
Nervous system disorders
Myasthenia Gravis
|
3.3%
1/30 • Number of events 1 • Patients were followed for a total of 36 weeks, including the 12 weeks of the study intervention, and the 6 month follow-up period.
|
0.00%
0/24 • Patients were followed for a total of 36 weeks, including the 12 weeks of the study intervention, and the 6 month follow-up period.
|
|
Musculoskeletal and connective tissue disorders
back pain flair up
|
3.3%
1/30 • Number of events 1 • Patients were followed for a total of 36 weeks, including the 12 weeks of the study intervention, and the 6 month follow-up period.
|
0.00%
0/24 • Patients were followed for a total of 36 weeks, including the 12 weeks of the study intervention, and the 6 month follow-up period.
|
|
Nervous system disorders
seizure
|
0.00%
0/30 • Patients were followed for a total of 36 weeks, including the 12 weeks of the study intervention, and the 6 month follow-up period.
|
4.2%
1/24 • Number of events 1 • Patients were followed for a total of 36 weeks, including the 12 weeks of the study intervention, and the 6 month follow-up period.
|
Additional Information
Johanna Chang, Senior Research Coordinator
Feinstein Institute for Medical Research at Northwell Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place