Overview

This trial is active, not recruiting.

Conditions stroke, cerebrovascular accident, cva, acute stroke, acute cerebrovascular accident, apoplexy
Treatments transcranial direct current stimulation
Phase phase 2/phase 3
Sponsor Beth Israel Deaconess Medical Center
Start date June 2006
End date February 2013
Trial size 80 participants
Trial identifier NCT00792428, 2005P-000346, NS45049

Summary

The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) vs sham (pretend) tDCS to the motor brain region to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with OT once a day for up to 10 days. Assessments will be done by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with OT.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Each subject will receive up to 10 days of traditional occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the primary motor region for up to 45 min.
transcranial direct current stimulation Non-invasive brain stimulation
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
(Sham Comparator)
Each subject will receive up to 10 days of traditional occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 45 min. over the primary motor region.
transcranial direct current stimulation Non-invasive brain stimulation
A sham current runs between two electrode positions and might affect the underlying brain tissue.

Primary Outcomes

Measure
3-Joint Range of Motion (3J-ROM)
time frame: Two Baseline Assessments; Treatment days 5, 10; Follow Up
Fugl-Meyer Assessment of Upper Extremity Motor Impairment
time frame: Two Baseline Assessments; Treatment days 5, 10; Follow-Up

Secondary Outcomes

Measure
Wolf-Motor-Function-Test
time frame: Two Baseline Assessments; Treatment days 5, 10; Follow-up
Functional MRI Activation Pattern
time frame: Baseline; Follow-up
Diffusion Tensor Imaging
time frame: Baseline; Follow-up
Transcranial Magnetic Stimulation (TMS)
time frame: Baseline; Follow-up
Motor Activity Log Rating Scales
time frame: 2 Baseline Assessments; Treatment Days 5, 10; Follow-up
Modified Ashworth Scale
time frame: Baseline; Treatment days 5, 10

Eligibility Criteria

Male or female participants from 21 years up to 80 years old.

Inclusion Criteria: - First time clinical ischemic stroke or cerebrovascular accident - At least 6 months out from first ischemic stroke prior to study enrollment - Healthy control volunteer who has not suffered a stroke Exclusion Criteria: - More than 1 stroke (older strokes) - Significant pre-stroke disability - A terminal medical illness or disorder with survival of less than 1 year - Co-existent major neurological or psychiatric diseases (e.g., epilepsy) - Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents - Active participation in other stroke recovery trials testing interventions

Additional Information

Official title Facilitating Motor Recovery After Stroke Using tDCS
Principal investigator Gottfried Schlaug, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.