Transcranial Direct Current Stimulation for Post-stroke Motor Recovery

NCT ID: NCT03826030

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2024-09-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham tDCS + mCIMT

Sham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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.

mCIMT

Intervention Type: BEHAVIORAL

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

2 mA tDCS + mCIMT

2 mA tDCS (Transcranial direct current stimulation) administers low dose or 2 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)

Group Type: ACTIVE_COMPARATOR

Low dose tDCS

Intervention Type: DEVICE

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

mCIMT

Intervention Type: BEHAVIORAL

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

4 mA + mCIMT

4 mA tDCS (Transcranial direct current stimulation) administers high dose or 4 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)

Group Type: ACTIVE_COMPARATOR

High dose tDCS

Intervention Type: DEVICE

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

mCIMT

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: DEVICE

Low dose tDCS

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

Intervention Type: DEVICE

High dose tDCS

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

Intervention Type: DEVICE

mCIMT

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

1. Primary intracerebral hematoma, subarachnoid hemorrhage or bi-hemispheric or bilateral brainstem ischemic strokes;

2. Medication use at the time of study that may interfere with tDCS, including but not limited to carbamazepine, flunarizine, sulpiride, rivastigmine, dextromethorphan;

3. Other co-existent neuromuscular disorders (pre- or post-stroke) affecting upper extremity motor function;

4. Other neurological disorders (pre- or post-stroke) affecting subject's ability to participate in the study;

5. Moderate to severe cognitive impairment defined as Montreal Cognitive Assessment (MOCA) score < 18/30;

6. History of medically uncontrolled depression or other neuro-psychiatric disorders despite medications either before or after stroke that may affect subject's ability to participate in the study;

7. Uncontrolled hypertension despite medical treatment(s) at the time of randomization, defined as SBP≥185 mmHg or DBP≥110 mmHg (patient can be treated, reassessed and randomized later);

8. Presence of any MRI/tDCS/TMS risk factors including but not limited to: 8a) an electrically, magnetically or mechanically activated metallic or nonmetallic implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; 8b) a non-fixed metallic part in any part of the body, including a previous metallic injury to eye; 8c) pregnancy (effects of MRI, TMS, and tDCS on the fetus are unknown); 8d) history of seizure disorder or post-stroke seizure; 8e) preexisting scalp lesion under the intended electrode placement or a bone defect or hemicraniectomy;

9. Planning to move from the local area within the next 6 months;

10. Life expectancy less than 6 months;

11. Has received Botulinum toxin injection to the affected upper extremity in the past 3 months prior to randomization or expectation that Botulinum will be given to the Upper Extremity prior to the completion of the last follow-up visit;

12. Concurrent enrollment in another investigational stroke recovery study;

13. Doesn't speak sufficient English to comply with study procedures;

14. Expectation that subject cannot comply with study procedures and visits.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wayne Feng, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Gottfried Schlaug, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Baystate Health

Locations

University of Alabama at Birmingham Hospital

Birmingham, Alabama, United States

Keck Hospital of USC

Los Angeles, California, United States

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, United States

Emory Rehabilitation Hospital

Atlanta, Georgia, United States

Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, United States

Baystate Medical Center

Springfield, Massachusetts, United States

Burke Rehabilitation Center

White Plains, New York, United States

Duke University Hospital

Durham, North Carolina, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Cleveland VA Medical Center

Cleveland, Ohio, United States

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, United States

University of Pittsburgh Medical Center Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina University Hospital

Charleston, South Carolina, United States

Memorial Hermann Texas Medical Center

Houston, Texas, United States

Countries

United States

References

Schlaug G, Cassarly C, Feld JA, Wolf SL, Rowe VT, Fritz S, Chhatbar PY, Shinde A, Su Z, Broderick JP, Zorowitz R, Awosika O, Edwards D, Lin C, Franciso GE, Wittenberg GF, Pundik S, Gregory C, Borich MR, Ramakrishnan V, Feng W. Safety and efficacy of transcranial direct current stimulation in addition to constraint-induced movement therapy for post-stroke motor recovery (TRANSPORT2): a phase 2, multicentre, randomised, sham-controlled triple-blind trial. Lancet Neurol. 2025 May;24(5):400-412. doi: 10.1016/S1474-4422(25)00044-4. Epub 2025 Mar 26.

Reference Type: DERIVED

PMID: 40157380 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U01NS102353

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00103316

Identifier Type: -

Identifier Source: org_study_id