Stroke
Conditions
Keywords
Stroke, Cerebrovascular Accident, Cerebral Stroke, CVA, Robotic therapy, Upper extremity recovery, tDCS, Non-invasive brain stimulation
Brief summary
The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.
Interventions
DEVICETranscranial Direct Current Stimulation (tDCS)
DEVICEPlacebo sham
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior * Cognitive function sufficient enough to understand experiments and follow instructions * Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
Exclusion criteria
* Botox treatment within 6 weeks of enrollment * Fixed contraction of the affected limb * Complete flaccid paralysis of the affected limb * History of hemorrhagic stroke * Ongoing use of CNS active medications * Ongoing use of psychoactive medications * Presence of additional potential tDCS/TMS risk factors including damaged skin at site of stimulation, presence of a magnetically/mechanically active implant, metal in the head, family history of epilepsy, and personal history of seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Change in Upper Extremity Fugl Meyer Assessment Score | baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Change in WOLF Motor Function Test (WMFT) | baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention) | 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. |
| Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC) | 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 30 |
| 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 | 24 |
| Total | 54 |
Baseline characteristics
| Characteristic | tDCS Sham + Robotic Arm Therapy | Total | tDCS + Robotic Arm Therapy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 24 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 30 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 33 Participants | 20 Participants |
| Sex: Female, Male Female | 9 Participants | 20 Participants | 11 Participants |
| Sex: Female, Male Male | 15 Participants | 34 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 24 |
| other Total, other adverse events | 2 / 30 | 1 / 24 |
| serious Total, serious adverse events | 0 / 30 | 0 / 24 |
Outcome results
Primary
Median Change in Upper Extremity Fugl Meyer Assessment Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| tDCS + Robotic Arm Therapy | Median Change in Upper Extremity Fugl Meyer Assessment Score | Median change from baseline to discharge at 12 wks | 4.5 scores on a scale |
| tDCS + Robotic Arm Therapy | Median Change in Upper Extremity Fugl Meyer Assessment Score | Median change from baseline to 6 month follow-up | 4 scores on a scale |
| tDCS Sham + Robotic Arm Therapy | Median Change in Upper Extremity Fugl Meyer Assessment Score | Median change from baseline to discharge at 12 wks | 6.0 scores on a scale |
| tDCS Sham + Robotic Arm Therapy | Median Change in Upper Extremity Fugl Meyer Assessment Score | Median change from baseline to 6 month follow-up | 6 scores on a scale |
p-value: 0.256Mann-Whitney U test
p-value: 0.222Mann-Whitney U test
Secondary
Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| tDCS + Robotic Arm Therapy | 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 |
| tDCS + Robotic Arm Therapy | 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 |
| tDCS Sham + Robotic Arm Therapy | 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 |
| tDCS Sham + Robotic Arm Therapy | 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 |
p-value: 0.68Mann-Whitney U test
p-value: 0.837Mann-Whitney U Test
Secondary
Median Change in WOLF Motor Function Test (WMFT)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| tDCS + Robotic Arm Therapy | Median Change in WOLF Motor Function Test (WMFT) | Median change from baseline to discharge at 12 wks | -34 seconds |
| tDCS + Robotic Arm Therapy | Median Change in WOLF Motor Function Test (WMFT) | Median change from baseline to 6 month follow-up | -103 seconds |
| tDCS Sham + Robotic Arm Therapy | Median Change in WOLF Motor Function Test (WMFT) | Median change from baseline to discharge at 12 wks | -19 seconds |
| tDCS Sham + Robotic Arm Therapy | Median Change in WOLF Motor Function Test (WMFT) | Median change from baseline to 6 month follow-up | -81.5 seconds |
p-value: 1Mann-Whitney U Test
p-value: 0.592Mann-Whitney U Test