Actively Recruiting

Phase Not Applicable
Age: 21Years - 80Years
All Genders
NCT05591196

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

Led by University of Washington · Updated on 2025-03-05

6

Participants Needed

1

Research Sites

221 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Radiologically documented single ischemic stroke resulting in hemiplegia or hemiparesis
  • At least six months have passed since the stroke
  • Upper Extremity Fugl-Meyer Assessment score between 29 and 53 inclusive at screening
  • Medically and neurologically stable based on medical history and physical exam
  • Negative pregnancy test for women of childbearing potential and willingness to use contraception
  • Ability to attend therapy sessions three times per week
  • Adequate social support for participation throughout the eight-month study
  • Ability to read, understand, and speak English
Not Eligible

You will not qualify if you...

  • Hemorrhagic stroke
  • History of multiple strokes
  • Presence of active implanted stimulators like pacemakers or cochlear implants
  • Aphasia or communication deficits interfering with study participation
  • Moderate to severe cognitive impairment
  • Presence of neglect affecting awareness or attention to the weaker side
  • Severe spasticity in the upper limb
  • Taking more than 30 mg/day of baclofen
  • Baclofen dose changes within four weeks before enrollment
  • Use of benzodiazepines, dantrolene, tizanidine, anticoagulants, or antiepileptic drugs
  • Botulinum toxin injection to upper limb muscles within six months before enrollment
  • Severe joint contractures in affected hand and arm
  • History of spontaneous seizures occurring one month or more after the stroke

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Washington

Seattle, Washington, United States, 98105

Actively Recruiting

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Research Team

F

Fatma Inanici

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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