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NCT05591196Recruiting

Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
6 (estimated)
First submitted
13 Oct 2022
Start date
1 Oct 2022
Primary completion date
31 Dec 2027
Lead sponsor
University of Washington
Diseases
Stroke
NCT number
NCT05591196

What you commit to

  • Study type: Interventional
  • Planned participants: 6
  • From 1 Oct 2022 to the primary completion date, 31 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Active implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
  • 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

Other illness

  • Hemorrhagic stroke
  • History of multiple strokes
  • Moderate to severe cognitive impairment
  • History of spontaneous seizure that had occurred one month or longer after the stroke

Other

  • Aphasia or any other deficit in communication that interferes with reasonable study participation
  • 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
  • Severe joint contractures in the affected hand and arm

Who the study is looking for

  • 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

Age in the registry: 21 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
University of Washington
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SeattleUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.