No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
21 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
6 (estimated)
Sponsor
University of Washington · Other
Who this trial is looking for
This trial is looking for people who have had a stroke and have trouble moving their hand and arm. Participants will receive electrical stimulation on their spinal cord and take part in rehabilitation exercises to help improve their movement.
Are You a Good Fit for This Trial?
Must not be takingBenzodiazepinesDantroleneTizanidineAnticoagulantsAntiepileptic medications
You may be able to join if
I have had a single ischemic stroke that caused weakness on one side.
I am at least six months post-stroke.
I can attend sessions three times a week.
I have some social support for participating in the study.
I can read, understand, and speak English.
You may not be able to join if
I have had a hemorrhagic stroke.
I have had multiple strokes.
I have an active implanted stimulator or baclofen pump.
I have severe cognitive impairment.
I have severe spasticity in my upper arm.
I have had botulinum toxin injection in my arm within the last six months.
I have a history of spontaneous seizures after my stroke.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The recovery from a stroke is often incomplete. It is the leading cause of acquired permanent disability in the adult population. Persistent functional loss of the hand and arm contributes significantly to disability. However, the current standard of care to treat hand and arm movements are inadequate. There is an urgent need for innovative and effective therapies for recovery of the upper limb af…
The recovery from a stroke is often incomplete. It is the leading cause of acquired permanent disability in the adult population. Persistent functional loss of the hand and arm contributes significantly to disability. However, the current standard of care to treat hand and arm movements are inadequate. There is an urgent need for innovative and effective therapies for recovery of the upper limb after stroke.
Growing evidence shows that electrical spinal cord stimulation, combined with activity-dependent rehabilitation, enables voluntary movement of paralyzed muscles in some neurologic disorders, such as spinal cord injury. The investigators hypothesize that spinal networks that lost control after stroke can be activated by non-invasive electrical stimulation of the spinal cord to improve functional recovery.
The aims of the study are:
1. to determine the improvements in hand and arm function that result from the combined application of non-invasive spinal stimulation and activity-based rehabilitation. Surface electrodes placed over the skin of the neck will be used for non-invasive electrical stimulation of the spinal cord. Functional task practice will be used for activity-dependent rehabilitation,
2. to evaluate long-lasting benefits to hand and arm function that persist beyond the period of spinal stimulation.
Trial Locations
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Eligibility Criteria
Inclusion 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 s…
Inclusion 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
Exclusion Criteria:
* 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
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