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

NCT ID: NCT05591196

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2026-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Activity Based Rehabilitation

Intervention Type: OTHER

Exercise therapy targeting paralyzed hand and arm

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).

Group Type: EXPERIMENTAL

Non-invasive Electrical Spinal Cord Stimulation

Intervention Type: DEVICE

Electrical stimulation of the spinal cord using surface electrodes

Activity Based Rehabilitation

Intervention Type: OTHER

Exercise therapy targeting paralyzed hand and arm

Interventions

Non-invasive Electrical Spinal Cord Stimulation

Electrical stimulation of the spinal cord using surface electrodes

Intervention Type: DEVICE

Activity Based Rehabilitation

Exercise therapy targeting paralyzed hand and arm

Intervention Type: OTHER

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 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Chet Moritz

Associate Professor, Electrical and Computer Engineering, Rehabilitation Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chet Moritz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Fatma Inanici

Role: CONTACT

finanici@uw.edu

206-787-2692

Facility Contacts

Fatma Inanici, MD, Ph.D.

Role: primary

finanici@uw.edu

2067872692

Other Identifiers

STUDY00015990

Identifier Type: -

Identifier Source: org_study_id