Brain Stimulation-aided Stroke Rehabilitation: Neural Mechanisms of Recovery

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

December 31, 2019

Study Completion Date

December 31, 2019

Conditions
Stroke
Interventions
PROCEDURE

tDCS: noninvasive brain stimulation

TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (1mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration. In the present study, tDCS will be delivered for 1 hr each day for 3 days a week for 5 weeks in conjunction with constraint-induced movement therapy for the affected hand.

BEHAVIORAL

Constraint induced movement therapy (CIMT)

Patients with stroke affecting the hand will receive constraint-induced movement therapy (CIMT) to re-train movements of the affected hand. Training will involve practicing tasks of daily living with qualified personnel. Training will be delivered for 1 hr each day for 3 days a week for 5 weeks. Patients will also be asked to use their affected hand in daily activities at home for 5 hrs a day while wearing a mitt on the unaffected hand.

PROCEDURE

Sham tDCS: placebo noninvasive brain stimulation

Placebo set-up for noninvasive brain stimulation will be similar to that for the active tDCS; sponge electrodes would be placed on the scalp and connected to a batter-operated device. Patients will not receive the effective level of direct current as would delivered in active tDCS intervention. But patients will not be able to decipher whether they are receiving active or placebo tDCS.

Trial Locations (1)

44195

The Cleveland Clinic, Cleveland

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

The Cleveland Clinic

OTHER

NCT01539096 - Brain Stimulation-aided Stroke Rehabilitation: Neural Mechanisms of Recovery | Biotech Hunter | Biotech Hunter