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| Sponsor: | Spaulding Rehabilitation Hospital |
|---|---|
| Information provided by (Responsible Party): | Felipe Fregni, Spaulding Rehabilitation Hospital |
| ClinicalTrials.gov Identifier: | NCT01143649 |
Purpose
The purpose of this study is to determine whether noninvasive brain stimulation associated with motor learning offers an additional benefit than motor learning alone in patients with stroke.
The investigators hypothesis is that active transcranial direct current stimulation (tDCS) combined with constraint induced movement therapy (CIMT) will induce a greater motor function improvement as compared with sham tDCS combined with CIMT.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Device: Transcranial Stimulation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients |
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2010 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: tDCS + CIMT
Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).
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Device: Transcranial Stimulation
Subjects will be stimulated at 1 mA for 40 minutes.
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Experimental: tDCS + motor training- Healthy Subjects
The investigators will have 40 healthy subjects who will undergo one day of treatment (in which the order in which they receive either sham or active tDCS stimulation will be randomized. Each stimulation day will include up to six hours of training termed "shaping" in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of either real tDCS at 1mA or sham tDCS.
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Device: Transcranial Stimulation
Subjects will be stimulated at 1 mA for 40 minutes.
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Active Comparator: tACS - Healthy Subjects
The investigators will have 40 healthy subjects who will undergo one day of treatment (in which the order in which they receive either sham or active transcranial alternating current stimulation (tACS) stimulation will be randomized.
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Device: Transcranial Stimulation
Subjects will be stimulated at 1 mA for 40 minutes.
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More study details will be provided by Spaulding Rehabilitation Hospital.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
All subjects must be between the ages of 18-90 and must not be pregnant.
Additional Entry criteria for Stroke subject enrollment:
Exclusion Criteria:
Contraindications to single pulse Transcranial Magnetic Stimulation (TMS) (TMS will be used to measure cortical excitability) such as metal head implants
Contraindications to tDCS
Contacts and Locations| United States, Massachusetts | |
| Spaulding Rehabilitation Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Felipe Fregni, PhD | Spaulding Rehabilitation Hospital |
More Information
| Responsible Party: | Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital |
| ClinicalTrials.gov Identifier: | NCT01143649 History of Changes |
| Other Study ID Numbers: | 2009p001808 |
| Study First Received: | April 20, 2010 |
| Last Updated: | September 12, 2011 |
| Health Authority: | United States: Institutional Review Board |
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Stroke Transcranial direct current stimulation Motor function |
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Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |