Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery "TDCS+OT"

Active, not recruiting

Phase 2/3 Results N/A

Update History

27 Jan '16
The Summary of Purpose was updated.
New
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 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) vs sham (pretend) tDCS to the motor brain region 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 OT once a day for up to 10 days. Assessments will be done 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 OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with OT.
Old
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 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) vs sham (pretend) tDCS to the motor brain region 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 OT once a day for up to 10 days. Assessments will be done 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 OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with OT.
The eligibility criteria were updated.
New
Inclusion Criteria: - First time clinical ischemic stroke or cerebrovascular accident - At least 6 months out from first ischemic stroke prior to study enrollment - Healthy control volunteer who has not suffered a stroke Exclusion Criteria: - More than 1 stroke (older strokes) - Significant pre-stroke disability - A terminal medical illness or disorder with survival of less than 1 year - Co-existent major neurological or psychiatric diseases (e.g., epilepsy) - Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents - Active participation in other stroke recovery trials testing interventions
Old
Inclusion Criteria: - First time clinical ischemic stroke or cerebrovascular accident - At least 6 months out from first ischemic stroke prior to study enrollment - Healthy control volunteer who has not suffered a stroke Exclusion Criteria: - More than 1 stroke (older strokes) - Significant pre-stroke disability - A terminal medical illness or disorder with survival of less than 1 year - Co-existent major neurological or psychiatric diseases (e.g., epilepsy) - Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents - Active participation in other stroke recovery trials testing interventions
31 Jan '15
A location was updated in Boston.
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The overall status was removed for Beth Israel Deaconess Medical Center / Harvard Medical School.