Transcranial Direct Current Stimulation for Post-stroke Motor Recovery

NCT03826030 | Completed Phase 2 Results DMC FDA Device

• 2 other identifiers: Pro00103316U01NS102353
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 14

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

Keywords

stroke; stroke recovery; brain stimulation; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Mean Change in FM-UE From Baseline

  The Fugl-Meyer Upper-Extremity (FM-UE) is a measure of motor impairment (0 to 66 points, with higher points indicating less impairment). FM-UE scale consists of a 33-item assessment which provides a global assessment of UE motor impairment. A rater provides an ordinal rating (2=near normal ability/response, 1=partial ability, 0=unable to perform/no response). The FM-UE scale is a proven scale with excellent intra-rater reliability (0.99), inter-rater reliability (0.99), test-retest reliability (0.94 -0.99), and internal consistency (0.97). FM-UE scale was assessed both by site raters (who were masked to the intervention) and by a central rater (who was masked to timepoint and intervention), by watching video recordings. The centrally rated score was used for the primary outcome analysis. For each element of the FM-UE scale, if the centrally rated score could not be determined, the site rater score was substituted.

  Day 15

Secondary Outcomes (2)

• Mean Change in WMFT Time Score From Baseline

  Day 15

• Mean Change in SIS Hand Subscale From Baseline

  Day 15

Study Arms (3)

Sham tDCS + mCIMT

SHAM COMPARATOR

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

Device: Sham; Behavioral: mCIMT

2 mA tDCS + mCIMT

ACTIVE COMPARATOR

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

Device: Low dose tDCS; Behavioral: mCIMT

4 mA + mCIMT

ACTIVE COMPARATOR

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

Device: High dose tDCS; Behavioral: mCIMT

Interventions

Sham 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.

Sham tDCS + mCIMT

Low dose tDCS DEVICE

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

2 mA tDCS + mCIMT

High dose tDCS DEVICE

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

4 mA + mCIMT

mCIMT BEHAVIORAL

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

2 mA tDCS + mCIMT; 4 mA + mCIMT; Sham tDCS + mCIMT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Each subject must meet all of the following criteria to participate in this study: 1. 18-80 years old; and 2. First-ever unihemispheric ischemic stroke radiologically verified and occurred within the past 30-180 days; and 3. \>10° of active wrist extension, \>10° of thumb abduction/extension, and \> 10° of extension in at least 2 additional digits; and 4. Unilateral limb weakness with a Fugl-Meyer Upper Extremity score of ≤ 54 (out of 66) to avoid ceiling effects; and 5. An absolute difference of FM-UE scores between the two baseline assessments that is ≤ 2 points indicating stable motor impairment; if subject is not stable, then he/she will be invited for a reassessment after 7-14 days (but no more than 3 reassessments); and 6. Pre-stroke mRS ≤2; and 7. Signed informed consent by the subject or Legally Authorized Representative (LAR). Each Subject who meets any of the following criteria will be excluded from the study: 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Duke University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (14)

University of Alabama at Birmingham Hospital

Birmingham, Alabama, 35249, United States

Location

Keck Hospital of USC

Los Angeles, California, 90089, United States

Location

MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Emory Rehabilitation Hospital

Atlanta, Georgia, 30322, United States

Location

Cardinal Hill Rehabilitation Hospital

Lexington, Kentucky, 40504, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Burke Rehabilitation Center

White Plains, New York, 10605, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

Location

Moss Rehabilitation Research Institute

Elkins Park, Pennsylvania, 19027, United States

Location

University of Pittsburgh Medical Center Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina University Hospital

Charleston, South Carolina, 29425, United States

Location

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 40157380 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Motor Activity; Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Wayne Feng, MD
• Organization: Duke University

wayne.feng@duke.edu

919-681-1700

Study Officials

• Wayne Feng, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Gottfried Schlaug, MD, PhD

  Baystate Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 1, 2019
• Study Start: September 1, 2019
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Please refer to https://nihstrokenet.org/ for detailed information in term of time-frame of sharing such data
• Access Criteria: Please refer to https://nihstrokenet.org/ for detailed information in term of time-frame of sharing such data

Locations

US (14)