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

NCT05591196 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00015990
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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. 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. 2.to evaluate long-lasting benefits to hand and arm function that persist beyond the period of spinal stimulation.

Conditions

Stroke, Ischemic; Chronic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change from baseline - Fugl-Meyer assessment of the upper limb

  The clinician-administered a stroke-specific, performance-based impairment scale. It assesses movement function, sensation, joint range of motion, and pain. The score ranges from 0 to 66. Higher scores indicate better outcomes.

  "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

  Measurement of hand strengths using a dynamometry.

  "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."

• Change from baseline - Modified Ashworth Scale

  Clinician-administered test for resistance of a joint to passive movement. This scale grades muscle tone/spasticity. The score ranges from 0 to 4. Higher scores indicate worse outcomes.

  "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

  Quantifies upper limb motor ability through timed and functional tasks. The score range is 0-75; higher scores denote better function.

  "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."

Secondary Outcomes (9)

• Change from baseline - Action Research Arm Test

  "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."

• Change from baseline - Box and Blocks Test

  "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months."

• Change from baseline - Revised Nottingham Sensory Assessment

  "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."

• Change from baseline - Stroke Impact Scale

  "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."

• Change from baseline - Short Form-36

  "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."

Study Arms (2)

Activity Based Rehabilitation

ACTIVE COMPARATOR

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).

Other: Activity Based Rehabilitation

Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation

EXPERIMENTAL

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).

Device: Non-invasive Electrical Spinal Cord Stimulation; Other: Activity Based Rehabilitation

Interventions

Non-invasive Electrical Spinal Cord Stimulation DEVICE

Electrical stimulation of the spinal cord using surface electrodes

Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation

Activity Based Rehabilitation OTHER

Exercise therapy targeting paralyzed hand and arm

Activity Based Rehabilitation; Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chet Moritz, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Inanici

CONTACT

206-787-2692; finanici@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Electrical and Computer Engineering, Rehabilitation Medicine

Model Details: Prospective, randomized, two-arm cross-over study: All participants will receive one of the two treatment arms one after the other. The order of the treatments will be randomized.

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 24, 2022
• Study Start: October 1, 2022
• Primary Completion: July 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)