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tDCS and Physical Therapy in Stroke

NCT00542256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2017-03-21

No results posted yet for this study

Summary

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

  • Cerebrovascular Accident

Interventions

DEVICE

Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

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.

DEVICE

Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy

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.

Sponsors & Collaborators

Principal Investigators

  • Felipe Fregni, MD, PhD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2014-11-10
Completion
2014-11-10

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00542256 on ClinicalTrials.gov