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Behavioral Intervention

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

Phase 2

Waitlist Available

Led By Wayne Feng, MD

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

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through day 15 (after the intervention) and follow-up at day 45 and 105

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a Botulinum toxin injection in my arm in the last 3 months.

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I have a condition affecting my arm or hand movement.

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I do not have any neurological disorders that would prevent me from participating in the study.

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I have had a stroke or bleeding in my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through day 15 (after the intervention) and follow-up at day 45 and 105

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change of Motor Impairment as Assessed by Fugl-Meyer Upper-Extremity (FM-UE) scale

Secondary study objectives

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

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)

0 / 8Eligibility criteria met