tDCS and Physical Therapy in Stroke

Recruiting

Phase 2 Results N/A

Trial Description

The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function.
We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.

Conditions

Interventions

  • Active transcranial Direct Current Stimulation/Constraint Induced Movement Therapy Behavioral
    Intervention Desc: Transcranial Direct Current Stimulation (tDCS) is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to inject currents in the brain and thus modulates the level of excitability.
  • Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy Device
    Intervention Desc: 14 days of constraint induced movement therapy with 10 weekdays of up to 6 hours of training of the affected arm combined with application of tDCS over the primary motor cortex for 40 minutes.
    ARM 1: Kind: Experimental
    Label: 1
    Description: Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each of the 10 weekday training sessions, participants will receive 40 minutes of active tDCS over the primary motor cortex.
  • Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy Device
    Intervention Desc: 14 days of constraint induced movement therapy with 10 days of up to 6 hours of training in the affected arm and sham tDCS applied over the primary motor cortex for 40 minutes with active current applied for 30 seconds.
    ARM 1: Kind: Experimental
    Label: 2
    Description: Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each training day tDCS will be applied for 40 minutes with the current active for only 30 seconds over the primary motor cortex.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Patient Involvement

Jebsen-Taylor Hand Function Test, Motor Activity Log Rating Scale, Beck Depression Inventory, and Visual Analogue Scale for Anxiety at baseline and treatment days 1,5, 10, and follow-up. Fugl Meyer Assessment of Motor Recovery, Barthel Index Score, and Modified Ashworth Scale at baseline. Subjects will be randomized to either the active or sham arm. Each subject in the active arm will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each of the 10 weekday training sessions, participants will receive 40 minutes of active tDCS over the primary motor cortex. In the sham arm, each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each training day tDCS will be applied for 40 minutes with the current active for only 30 seconds over the primary motor cortex.

Outcomes

Type Measure Time Frame Safety Issue
Primary Jebsen-Taylor Hand Function Test; Motor Activity Log Rating Scale; Beck Depression Inventory; Visual Analogue Scale for Anxiety.
Secondary Fugl Meyer Assessment of Motor Recovery; Barthel Index Score; Modified Ashworth Scale.
Primary Jebsen-Taylor Hand Function Test Baseline, Treatment days 1,5,10, Follow Up
Primary Motor Activity Log Rating Scale Baseline, Treatment Days 1,5,10 and Follow Up
Primary Beck Depression Inventory Baseline, Treatment days 1,5,10 and Follow up
Primary Visual Analogue Scale for Anxiety Baseline, Treatment days 1,5,10 and Follow Up
Secondary Fugl Meyer Assessment of Motor Recovery Baseline Assessment
Secondary Barthel Index Score Baseline Assessment
Secondary Modified Ashworth Scale Baseline Assessment

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