Recruiting

Spinal Cord Stimulation

Sponsor:

University of Washington

Code:

NCT05591196

Conditions

Stroke, Ischemic

Chronic Stroke

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Non-invasive Electrical Spinal Cord Stimulation

Activity Based Rehabilitation

Study Details

Brief summary:

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

Stroke, Ischemic

Chronic Stroke

Study ID

NCT05591196

Start date

Oct 1, 2022

Status verified date

Feb, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

6 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Activity Based Rehabilitation

Activity Based Rehabilitation is comprised of intensive, progressive, functional task practice. The protocol consists of repetitive activities of gross upper limb movement, isolated finger movements, bimanual task performance, simple and complex pinch, and grip performance. Several activities with various difficulty levels are designated for each category, and the participant will perform 1-2 activities within each category in each rehabilitation session. Rehabilitation sessions will be three times per week, 90 minutes per session for six weeks (total of 18 sessions).

experimental: Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation

Non-invasive electrical spinal cord stimulation will be performed using surface electrodes placed over the skin of the neck. Biphasic rectangular pulses of 1 millisecond per phase duration will be delivered with a 10 kiloHertz overlapping frequency and between 20-120 Hertzz burst frequency. Non-invasive electrical spinal cord stimulation will be paired with Activity Based Rehabilitation sessions. Stimulation plus rehabilitation sessions will be three times per week, 90 minutes per session for six weeks (total of 18 sessions).

Interventions

Non-invasive Electrical Spinal Cord Stimulation

Electrical stimulation of the spinal cord using surface electrodes

Activity Based Rehabilitation

Exercise therapy targeting paralyzed hand and arm

Primary outcome measure

  • Change from baseline - Fugl-Meyer assessment of the upper limb [ Time Frame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months." ]
  • Change from baseline - Pinch and grip force [ Time Frame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months." ]
  • Change from baseline - Modified Ashworth Scale [ Time Frame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months." ]
  • Change from baseline - Wolf Motor Function Test [ Time Frame: "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months." ]

Central Contacts and Locations

Central contacts

Fatma Inanici

206-787-2692finanici@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98105

Contacts

Fatma Inanici, MD, Ph.D.

2067872692finanici@uw.edu

Principal Investigator:

Chet T Moritz, PhD

More Information

Sponsor

University of Washington

Last update posted

Mar 5, 2025

Last verified

Feb, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2025-03-05.