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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS + robotic arm therapy | Experimental | 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) |
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| tDCS sham + robotic arm therapy | Placebo Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation (tDCS) | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce T Volpe, MD | Feinstein Institute for Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Feinstein Institute for Medical Research | Manhasset | New York | 11030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19531875 | Background | Edwards DJ, Krebs HI, Rykman A, Zipse J, Thickbroom GW, Mastaglia FL, Pascual-Leone A, Volpe BT. Raised corticomotor excitability of M1 forearm area following anodal tDCS is sustained during robotic wrist therapy in chronic stroke. Restor Neurol Neurosci. 2009;27(3):199-207. doi: 10.3233/RNN-2009-0470. | |
| 34963502 | Derived |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | Inter-Quartile Range | scores on a scale | baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention) |
|
Patients were followed for a total of 36 weeks, including the 12 weeks of the study intervention, and the 6 month follow-up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | tDCS + Robotic Arm Therapy | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myasthenia Gravis | Nervous system disorders | Non-systematic Assessment | Subject developed spontaneous eye pstosis at home and was diagnosed with Myasthenia Gravis by treating physician, unrelated to study intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johanna Chang, Senior Research Coordinator | Feinstein Institute for Medical Research at Northwell Health | (516) 562-3646 | jchang14@northwell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2016 | May 14, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Placebo sham | Device |
|
|
| baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention) |
| 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. | 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) |
| Moretti CB, Hamilton T, Edwards DJ, Peltz AR, Chang JL, Cortes M, Delbe ACB, Volpe BT, Krebs HI. Robotic Kinematic measures of the arm in chronic Stroke: part 2 - strong correlation with clinical outcome measures. Bioelectron Med. 2021 Dec 29;7(1):21. doi: 10.1186/s42234-021-00082-8. |
| 34963501 | Derived | Moretti CB, Edwards DJ, Hamilton T, Cortes M, Peltz AR, Chang JL, Delbem ACB, Volpe BT, Krebs HI. Robotic Kinematic measures of the arm in chronic Stroke: part 1 - Motor Recovery patterns from tDCS preceding intensive training. Bioelectron Med. 2021 Dec 29;7(1):20. doi: 10.1186/s42234-021-00081-9. |
| 33175411 | Derived | Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4. |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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) |
| OG001 | 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 |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | seconds | baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention) |
|
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | scores on a scale | 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention) |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 2 |
| 30 |
| EG001 | 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 | 0 | 24 | 0 | 24 | 1 | 24 |
|
| back pain flair up | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Subject developed flair up of lower back pain as a result of compromised gait pattern after stroke and consequently had to drop out of the study. |
|
| seizure | Nervous system disorders | Systematic Assessment | Subject from the sham condition experienced a seizure at home greater than 48 hrs after stimulation, and seizure was determined to be unrelated to study intervention by subject's treating neurologist. Subject was withdrawn from study. |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| Mann-Whitney U Test | 0.592 | The Mann-Whitney U test was performed to compare median change in the WMFT time score from baseline to 36 weeks ( 6 month follow-up) across two separate study conditions (active vs. sham tDCS). | U value | 208.5 | 2-Sided | Equivalence | Statistical analysis of median change from baseline to week 36 (6 month follow-up) was assessed with the WOLF Motor Function test time score (out of 1800 seconds) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in WMFT time score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed). |
| Mann-Whitney U Test | 0.837 | The Mann-Whitney U test was performed to compare median change in the MRC score from baseline to 6 month FU across two separate study conditions (active vs. sham tDCS). | U value | 187.5 | 2-Sided | Equivalence | Statistical analysis of median change from baseline to week 36 (6 month FU) was assessed with the Motor Power Manual Muscle Test Score for the upper extremity (out of 100 points) in the active vs. sham tDCS conditions. Null hypothesis is that there is no difference in median change in MRC score between the active and sham tDCS conditions. A significance level of 0.05 was used (two-tailed). |