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| ID | Type | Description | Link |
|---|---|---|---|
| R01NS045049 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with traditional physical-occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on both hemispheres - in a dual configuration - to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days. Assessments will be done about 3 days and 7 days after the end of the experimental treatment by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with PT-OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with PT-OT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-tDCS + PT-OT | Active Comparator | Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min. |
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| Sham-tDCS + PT-OT | Sham Comparator | Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real Transcranial Direct Current Stimulation | Device | A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue |
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| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment of Upper Extremity Motor Impairment | This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome. | Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf-Motor-Function-Test | The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task," or similar as accurate. The average time in seconds is then log10 transformed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gottfried Schlaug, MD, PhD | Beth Israel Deaconess Medical Center / Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center / Harvard Medical School | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18973584 | Background | Vines BW, Nair D, Schlaug G. Modulating activity in the motor cortex affects performance for the two hands differently depending upon which hemisphere is stimulated. Eur J Neurosci. 2008 Oct;28(8):1667-73. doi: 10.1111/j.1460-9568.2008.06459.x. | |
| 18957075 | Background | Vines BW, Cerruti C, Schlaug G. Dual-hemisphere tDCS facilitates greater improvements for healthy subjects' non-dominant hand compared to uni-hemisphere stimulation. BMC Neurosci. 2008 Oct 28;9:103. doi: 10.1186/1471-2202-9-103. |
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There were no significant events that occurred after participant enrollment, prior to assignment.
We advertised in local media, on Craig's list, and informed neurology colleagues and rehabilitation specialists about our trial. Stroke patients had to be at least 5 months out from their stroke and had to have a moderate impairment in their upper extremity weakness.
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| ID | Title | Description |
|---|---|---|
| FG000 | Real-tDCS + PT-OT | Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min. Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sham Transcranial Direct Current Stimulation | Device | A sham current runs between two electrode positions and might affect the underlying brain tissue. |
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| Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days |
| 17070707 | Background | Nair DG, Hutchinson S, Fregni F, Alexander M, Pascual-Leone A, Schlaug G. Imaging correlates of motor recovery from cerebral infarction and their physiological significance in well-recovered patients. Neuroimage. 2007 Jan 1;34(1):253-63. doi: 10.1016/j.neuroimage.2006.09.010. Epub 2006 Oct 27. |
| 16603933 | Background | Vines BW, Nair DG, Schlaug G. Contralateral and ipsilateral motor effects after transcranial direct current stimulation. Neuroreport. 2006 Apr 24;17(6):671-4. doi: 10.1097/00001756-200604240-00023. |
| 21068427 | Result | Lindenberg R, Renga V, Zhu LL, Nair D, Schlaug G. Bihemispheric brain stimulation facilitates motor recovery in chronic stroke patients. Neurology. 2010 Dec 14;75(24):2176-84. doi: 10.1212/WNL.0b013e318202013a. Epub 2010 Nov 10. |
| FG001 | Sham-tDCS + PT-OT | Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region. Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Real-tDCS + PT-OT | Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min. Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue |
| BG001 | Sham-tDCS + PT-OT | Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region. Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue. |
| BG002 | Total | Total of all reporting groups |
| 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Fugl-Meyer Assessment of Upper Extremity Motor Impairment | This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome. | Posted | Mean | Standard Deviation | units on a scale [0-66] | Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days |
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| Secondary | Wolf-Motor-Function-Test | The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task," or similar as accurate. The average time in seconds is then log10 transformed. | Posted | Mean | Standard Deviation | units on a scale (log(sec)) | Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days |
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Over the 5 days of experimental treatment and during the 1 week follow-up.
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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 | Real-tDCS + PT-OT | Subjects are receiving real tDCS in a dual configuration centered over the motor region on both hemispheres for 30 minutes while they are also receiving PT-OT for 60 minutes total. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | Sham tDCS + PT-OT | Subjects are receiving sham tDCS in a dual configuration over both motor regions for 30 minutes while they are also receiving PT-OT for 60 minutes | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gottfried Schlaug, MD, PhD | Beth Israel Deaconess Medical Center | 617-632-8917 | gschlaug@bidmc.harvard.edu |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D007511 | Ischemia |
| D007238 | Infarction |
| D002561 | Cerebrovascular Disorders |
| D002493 | Central Nervous System Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Post-treatment2 (7 days after 5 days of treatment) |
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