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tDCS + Physical Therapy for Stroke Recovery (TRANSPORT 2 Trial)
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.
TRANSPORT 2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTRANSPORT 2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.TRANSPORT 2 Trial Design
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Who is running the clinical trial?
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- I have weakness in one arm with a moderate level of impairment.You are expected to live for less than 6 months.I am between 18 and 80 years old.I was mostly independent before my stroke.You have any metal or non-metal implants that can be affected by electric or magnetic fields, or have any preexisting scalp lesion or bone defect in the area where the treatment will be applied.I can move my wrist, thumb, and fingers more than 10 degrees.Your motor impairment score should stay about the same between two baseline assessments. If it changes too much, you may be asked to come back for additional assessments.You have a history of severe depression or other mental health disorders that may make it difficult for you to take part in the study.I had my first stroke in one side of my brain between 1 to 6 months ago.I have had a Botulinum toxin injection in my arm in the last 3 months.I have a condition affecting my arm or hand movement.You have significant difficulty with thinking and memory, as measured by a specific test score.I do not have any neurological disorders that would prevent me from participating in the study.I have had a stroke or bleeding in my brain.My high blood pressure is not controlled by medication.I am not taking medications like carbamazepine that could affect the study.
- Group 1: 2 mA tDCS + mCIMT
- Group 2: 4 mA + mCIMT
- Group 3: Sham tDCS + mCIMT
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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"
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- University of Texas Health Science Center / TIRR Memorial Hermann: < 48 hours
Average response time
- < 2 Days
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