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Transcranial Direct Current Stimulation for Post-stroke Motor Recovery

NCT03826030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2025-08-22

Study results available
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Summary

This research study is to find out if brain stimulation at different dosage level combined with an efficacy-proven rehabilitation therapy can improve arm function. The stimulation technique is called transcranial direct current stimulation (tDCS). The treatment uses direct currents to stimulate specific parts of the brain affected by stroke. The adjunctive rehabilitation therapy is called "modified Constraint-Induced Movement Therapy" (mCIMT). During this therapy the subject will wear a mitt on the hand of the arm that was not affected by a stroke and force to use the weak arm. The study will test 3 different doses of brain stimulation in combination with mCIMT to find out the most promising one.

Conditions

  • Stroke, Ischemic
  • Motor Activity
  • Upper Extremity Paralysis

Interventions

DEVICE

Sham

Sham group only receives 30 seconds of stimulation at 2mA in the beginning to create a sensory perception to the scalp in order to blind the subject.

DEVICE

Low dose tDCS

The low dose tDCS group receives direct current stimulation at 2 mA for 30 minutes per session

DEVICE

High dose tDCS

The high dose tDCS group receives direct current stimulation at 4 mA for 30 minutes per session

BEHAVIORAL

mCIMT

All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Wayne Feng, MD · Duke University

  • Gottfried Schlaug, MD, PhD · Baystate Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2024-09-19
Completion
2024-09-19
FDA Device
Yes

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 NCT03826030 on ClinicalTrials.gov