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Use of Transcranial Direct Current Stimulation (tDCS) Coupled With Constraint Induced Movement Therapy in Stroke Patient (tdcs Trial)
N/A
Waitlist Available
Led By Felipe Fregni, PhD
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 minutes
Summary
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.
Eligible Conditions
- Stroke
- Healthy Subjects
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cortical Excitability
Electroencephalography
Jebsen Taylor Hand Function Test
Trial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: tACS - Healthy SubjectsExperimental Treatment1 Intervention
The investigators will have 40 healthy subjects who will undergo one session of treatment with active tACS (in which the order in which they receive either sham or active transcranial alternating current stimulation (tACS) stimulation will be randomized).
Group II: active tDCS + CIMT - stroke patientsExperimental Treatment2 Interventions
Participants will receive 5 sessions of 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).
Group III: active tDCS + CIMT - HealthyExperimental Treatment2 Interventions
Participants will receive one session of 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)
Group IV: sham tDCS + CIMT - HealthyPlacebo Group2 Interventions
Participants will receive one session of 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). The sham stimulation consists of 30 seconds of stimulation at the beginning of the 40 min of treatment.
Group V: sham tACS - Healthy SubjectsPlacebo Group1 Intervention
The investigators will have 40 healthy subjects who will undergo one day of treatment with sham tACS. All participants received active and sham stimulation in a randomized order.
Group VI: sham tDCS + CIMT - stroke patientsPlacebo Group2 Interventions
Participants will receive 5 sessions of 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). For the sham session, tDCS is turned off after 30seconds.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial direct current stimulation (tDCS)
2014
N/A
~820
constraint induced movement therapy (CIMT)
2010
N/A
~50
transcranial alternating current stimulation (tACS)
2020
Completed Phase 4
~470
Find a Location
Who is running the clinical trial?
Spaulding Rehabilitation HospitalLead Sponsor
139 Previous Clinical Trials
11,044 Total Patients Enrolled
25 Trials studying Stroke
918 Patients Enrolled for Stroke
Felipe Fregni, PhDPrincipal InvestigatorSpaulding Rehabilitation Hospital
2 Previous Clinical Trials
25 Total Patients Enrolled