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New treatment option for Stroke, Ischemic
Official title Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
ClinicalTrials.gov ID: NCT05591196
What this study is testing
- What it's testing
- The recovery from a stroke is often incomplete. It is the leading cause of acquired permanent disability in the adult population.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 80
You may be able to join if
- Radiologically documented single ischemic stroke resulted in hemiplegia/hemiparesis
- At least six months post-stroke
- Upper Extremity Fugl-Meyer Assessment score "moderate" or "moderate-mild" (29-53 inclusive out of 66) at the screening visit
- Medically and neurologically stable, as determined by medical history and documented physical examination
- For women of childbearing potential, a negative over-the-counter pregnancy test at study entry and willingness to practice adequate contraception...
You likely can't join if
- Hemorrhagic stroke
- History of multiple strokes
- Active implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
- Aphasia or any other deficit in communication that interferes with reasonable study participation
- Moderate to severe cognitive impairment
- Presence of neglect (inability to perceive or awareness of, or loss of attention to the weaker half of the body)
See the full eligibility criteria
- Radiologically documented single ischemic stroke resulted in hemiplegia/hemiparesis
- At least six months post-stroke
- Upper Extremity Fugl-Meyer Assessment score "moderate" or "moderate-mild" (29-53 inclusive out of 66) at the screening visit
- Medically and neurologically stable, as determined by medical history and documented physical examination
- For women of childbearing potential, a negative over-the-counter pregnancy test at study entry and willingness to practice adequate contraception during the study
- Ability to attend sessions three times per week
- Adequate social support to participate in all intervention and baseline, follow-up assessment sessions throughout eight months.
- Ability to read, comprehend and speak English
- Hemorrhagic stroke
- History of multiple strokes
- Active implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
- Aphasia or any other deficit in communication that interferes with reasonable study participation
- Moderate to severe cognitive impairment
- Presence of neglect (inability to perceive or awareness of, or loss of attention to the weaker half of the body)
- Severe spasticity in the upper limb
- Taking baclofen more than 30 mg/day
- Change in baclofen dose within four weeks before enrollment
- Receiving benzodiazepines, dantrolene, tizanidine, anticoagulant, or antiepileptic medication
- Botulinum toxin injection to the upper limb muscles within six months before enrollment
- Severe joint contractures in the affected hand and arm
- History of spontaneous seizure that had occurred one month or longer after the stroke
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.