RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-01
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05591196

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Radiologically documented single ischemic stroke resulted in hemiplegia/hemiparesis
  2. * At least six months post-stroke
  3. * Upper Extremity Fugl-Meyer Assessment score "moderate" or "moderate-mild" (29-53 inclusive out of 66) at the screening visit
  4. * Medically and neurologically stable, as determined by medical history and documented physical examination
  5. * For women of childbearing potential, a negative over-the-counter pregnancy test at study entry and willingness to practice adequate contraception during the study
  6. * Ability to attend sessions three times per week
  7. * Adequate social support to participate in all intervention and baseline, follow-up assessment sessions throughout eight months.
  8. * Ability to read, comprehend and speak English
  1. * Hemorrhagic stroke
  2. * History of multiple strokes
  3. * Active implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
  4. * Aphasia or any other deficit in communication that interferes with reasonable study participation
  5. * Moderate to severe cognitive impairment
  6. * Presence of neglect (inability to perceive or awareness of, or loss of attention to the weaker half of the body)
  7. * Severe spasticity in the upper limb
  8. * Taking baclofen more than 30 mg/day
  9. * Change in baclofen dose within four weeks before enrollment
  10. * Receiving benzodiazepines, dantrolene, tizanidine, anticoagulant, or antiepileptic medication
  11. * Botulinum toxin injection to the upper limb muscles within six months before enrollment
  12. * Severe joint contractures in the affected hand and arm
  13. * History of spontaneous seizure that had occurred one month or longer after the stroke

Contacts and Locations

Study Contact

Fatma Inanici
CONTACT
206-787-2692
finanici@uw.edu

Principal Investigator

Chet Moritz, PhD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of Washington
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Chet Moritz, PhD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-01
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-10-01
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Chronic ischemic stroke
  • Transcutaneous spinal cord stimulation
  • Activity based rehabilitation

Additional Relevant MeSH Terms

  • Stroke, Ischemic
  • Chronic Stroke