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Stroke, IschemicPhase 2TRANSPORT 2NCT03826030

Transcranial Direct Current Stimulation for Post-stroke Motor Recovery

A Phase 2 study testing Low dose tDCS, High dose tDCS and mCIMT in people with Stroke, Ischemic and Motor Activity, run by Duke University at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Low dose tDCS, High dose tDCS and mCIMT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
129 participants
Where
14 sitesUnited States
Study dates
1 Sep 2019to 19 Sep 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Emory Rehabilitation Hospital

    Atlanta, Georgia, 30322

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35249

  • Medical University of South Carolina University Hospital

    Charleston, South Carolina, 29425

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Cleveland VA Medical Center

    Cleveland, Ohio, 44106

  • Duke University Hospital

    Durham, North Carolina, 27710

  • Moss Rehabilitation Research Institute

    Elkins Park, Pennsylvania, 19027

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

  • Cardinal Hill Rehabilitation Hospital

    Lexington, Kentucky, 40504

  • Keck Hospital of USC

    Los Angeles, California, 90089

  • University of Pittsburgh Medical Center Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • MedStar National Rehabilitation Hospital

    Washington D.C., District of Columbia, 20010

  • Burke Rehabilitation Center

    White Plains, New York, 10605

Other trials in United States

About this study

Official title: TRANScranial Direct Current Stimulation for POst-stroke Motor Recovery - a Phase II sTudy (TRANSPORT 2)

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.

Being tested
Sham, Low dose tDCS, High dose tDCS, mCIMT
Keywords
stroke, stroke recovery, brain stimulation, transcranial direct current stimulation
Medical subject headings
Ischemic Stroke, Motor Activity, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ShamDevice

    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.

  • Low dose tDCSDevice

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

  • High dose tDCSDevice

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

  • mCIMTBehavioural

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

Study groups in NCT03826030
Study groupRoleWhat they receive
Sham tDCS + mCIMTSham comparatorSham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
Receives: Device: Sham; Behavioral: mCIMT
2 mA tDCS + mCIMTActive comparator2 mA tDCS (Transcranial direct current stimulation) administers low dose or 2 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
Receives: Device: Low dose tDCS; Behavioral: mCIMT
4 mA + mCIMTActive comparator4 mA tDCS (Transcranial direct current stimulation) administers high dose or 4 milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)
Receives: Device: High dose tDCS; Behavioral: mCIMT

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 15

Secondary outcomes (2)

  1. Mean Change in WMFT Time Score From Baseline

    The Wolf Motor Function Test (WMFT) is a measure of functional motor activity that quantifies upper extremity (UE) motor ability through timed and functional tasks. The WMFT Time Score the median of 15 timed arm movements and hand dexterity tasks, each to be completed in 120s. If a task could not be completed in 120s, a score of 121s was assigned. A lower WMFT Time Score is better.

    Measured: Day 15

  2. Mean Change in SIS Hand Subscale From Baseline

    The Stroke Impact Scale (SIS) has 8 subscales which ask questions regarding a patient's physical limitations, memory and thinking, emotions and mood, ability to communicate, daily activities, mobility at home and in the community, use of hand most affected by stroke, and ability to participate in meaningful life activities. Each subscale item is rated on a scale from 5-1 (5= None of the time, 4=a little of the time, 3=Some of the time, 2=Most of the time, 1=All of the time). The domain/subscale scores, including the SIS Hand Subscale, range from 0 (worst) to 100 (best).

    Measured: Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2019
  2. Study start1 Sep 2019
  3. Primary completion19 Sep 2024
  4. Study completion19 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03826030
Sponsor's protocol ID
Pro00103316
Other IDs
U01NS102353
Acronym
TRANSPORT 2
Status last verified
Aug 2025
First submitted
30 Jan 2019
Last updated
22 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: We will follow the National Institute of Health Stroke Trial Network policy and procedure to share IPD. Please refer to https://nihstrokenet.org/ for detailed information.

Publications

  • 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.

    PubMed 40157380

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Low dose tDCS, High dose tDCS and mCIMT in people with Stroke, Ischemic and Motor Activity, run by Duke University at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in FM-UE From Baseline (time frame: Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03826030, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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