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Behavioral Intervention

tDCS + Physical Therapy for Stroke Recovery (TRANSPORT 2 Trial)

Phase 2
Recruiting
Led By Gottfried Schlaug, MD, PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unilateral limb weakness with a Fugl-Meyer Upper Extremity score of ≤ 54 (out of 66) to avoid ceiling effects
18-80 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 15 (after the intervention) and follow-up at day 45 and 105
Awards & highlights

TRANSPORT 2 Trial Summary

This trial is testing if combining brain stimulation with an existing physical therapy can improve arm function for people who have had a stroke.

Who is the study for?
This trial is for adults aged 18-80 who've had their first ischemic stroke within the last 30-180 days, leading to arm weakness but still retain some movement. They must be stable in their motor impairment and have a reasonable pre-stroke level of independence. Excluded are those with severe cognitive issues, other neurological disorders, certain metal implants or injuries, uncontrolled conditions like hypertension, or use of interfering medications.Check my eligibility
What is being tested?
The study tests three doses of transcranial direct current stimulation (tDCS), which uses electrical currents to stimulate the brain after a stroke. It's paired with modified Constraint-Induced Movement Therapy (mCIMT) where participants use their weaker arm while the stronger one is restrained to improve arm function.See study design
What are the potential side effects?
Possible side effects from tDCS may include mild tingling, itching or discomfort at the electrode site on the scalp during stimulation. There might also be fatigue or headache following treatment sessions.

TRANSPORT 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have weakness in one arm with a moderate level of impairment.
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I am between 18 and 80 years old.
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I was mostly independent before my stroke.
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I can move my wrist, thumb, and fingers more than 10 degrees.
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I had my first stroke in one side of my brain between 1 to 6 months ago.

TRANSPORT 2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 15 (after the intervention) and follow-up at day 45 and 105
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through day 15 (after the intervention) and follow-up at day 45 and 105 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change of Motor Impairment as Assessed by Fugl-Meyer Upper-Extremity (FM-UE) scale
Secondary outcome measures
Mean Change of Functional Motor Activity as assessed by Wolf Motor Function Test (WMFT)
Mean Change of Patient Centered Quality of Life as Assessed by Stroke-Impact-Scale(SIS) hand subscale

TRANSPORT 2 Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: 2 mA tDCS + mCIMTActive Control2 Interventions
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 II: 4 mA + mCIMTActive Control2 Interventions
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 III: Sham tDCS + mCIMTPlacebo Group2 Interventions
Sham tDCS (Transcranial direct current stimulation) administers no dose or zero milliampere stimulation through the tDCS device, during Constraint Induced Movement Therapy (mCIMT)

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,359 Previous Clinical Trials
3,420,180 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,235 Total Patients Enrolled
Gottfried Schlaug, MD, PhDPrincipal InvestigatorBaystate Health
3 Previous Clinical Trials
64 Total Patients Enrolled

Media Library

mCIMT (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03826030 — Phase 2
Upper Limb Paralysis Research Study Groups: 2 mA tDCS + mCIMT, 4 mA + mCIMT, Sham tDCS + mCIMT
Upper Limb Paralysis Clinical Trial 2023: mCIMT Highlights & Side Effects. Trial Name: NCT03826030 — Phase 2
mCIMT (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03826030 — Phase 2
Upper Limb Paralysis Patient Testimony for trial: Trial Name: NCT03826030 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being accepted for enrollment in this trial?

"Affirmative. Records of this clinical trial hosted on clinicaltrials.gov denote that it is currently enrolling patients, having been published as early as September 1st 2019 and amended most recently on August 26th 2022. With 13 distinct sites in the mix, 129 participants are to be recruited overall."

Answered by AI

Who is eligible to participate in this medical experiment?

"This trial is open to 129 people aged between 18 and 80 who have motor activities. To qualify, patients must also meet the following requirements: They should not be suffering from other neuromuscular disorders affecting their upper limb function; their first-ever unihemispheric stroke needs to have occurred within 30-180 days of enrolment; they need to display active wrist extension greater than 10° in addition to thumb abduction/extension and extension across two fingers exceeding 10° each; a Fugl-Meyer Upper Extremity score lower or equal than 54 out of 66 (to avoid ceiling effects); an absolute difference between baseline"

Answered by AI

Are senior citizens eligible for participation in this medical experiment?

"This trial is searching for participants over the age of majority and less than 80 years old."

Answered by AI

Does the Food and Drug Administration sanction four milliamperes of motor-controlled intermittent rhythmic therapy?

"Due to the lack of clinical evidence supporting efficacy, 4 mA + mCIMT received a score of 2. However, there is some data indicating its safety in Phase 2 trials."

Answered by AI

How many subjects are being recruited for this clinical trial?

"Yes, it appears that recruitment is still ongoing. Clinicaltrials.gov documents the launch of this study on September 1st 2019 and a recent update made to its details on August 26th 2022. A total of 129 subjects are needed between 13 different research centres."

Answered by AI

How many medical facilities are currently researching this trial?

"Patients are being sought at Burke Neurological Institute in White Plains, New york, Cleveland VA Medical Center in Cleveland, Ohio, and Burke Rehabilitation Institute in Washington D.C., amongst 13 additional medical centres."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
MedStar National Rehabilitation Hospital
University of Texas Health Science Center / TIRR Memorial Hermann
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I am seeking more resources to aid in my stroke recovery.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. University of Texas Health Science Center / TIRR Memorial Hermann: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Transcranial Direct Current Stimulation for Post-stroke Motor Recovery
2019. "Transcranial Direct Current Stimulation for Post-stroke Motor Recovery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03826030.
All > Tdcs
~11 spots leftby Oct 2024
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