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NCT Number: NCT05591196

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

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Stroke Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98105, United States

Location status: Recruiting

Location contact

Chet T Moritz, PhD

PRINCIPAL_INVESTIGATOR

Fatma Inanici, MD, Ph.D.

CONTACT

[email protected]

2067872692

Fatma Inanici, MD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive Electrical Spinal Cord Stimulation

Device

Electrical stimulation of the spinal cord using surface electrodes

Activity Based Rehabilitation

Other

Exercise therapy targeting paralyzed hand and arm

Primary outcomes

  1. 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."

    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.

  2. 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."

    Measurement of hand strengths using a dynamometry.

  3. 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."

    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.

  4. 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."

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

Secondary outcomes

  1. Change from baseline - Action Research Arm Test

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

    Clinician-administered observational measure to assess upper extremity performance, such as coordination, dexterity, and functioning, in stroke recovery.

  2. Change from baseline - Box and Blocks Test

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

    Participants move, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60 seconds. Measures gross manual dexterity.

  3. Change from baseline - Revised Nottingham Sensory Assessment

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

    A standardized scale for assessing sensory impairment in stroke patients. Tactile sensation, proprioception, stereognosis, and two-point discrimination are evaluated.

  4. Change from baseline - Stroke Impact Scale

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

    A self-report questionnaire that evaluates disability and health-related quality of life after stroke. The questionnaire consists of 8 domains: strength, memory and thinking, emotion, communication, activities of daily living, mobility, hand function, and participation/role function. The score ranges from 0 to 100. Higher scores indicate better outcomes.

  5. Change from baseline - Short Form-36

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

    A self-report health survey questionnaire. The score range from 0 to 100. The higher the score, the better the outcome.

  6. Change from baseline - Patients Global Impression of Change

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

    A self-report measure that reflects the participant's belief about the efficacy of treatment: the participant chooses the level of improvement and their functional status between much worse, worse, no change, improved and much improved, compared to the baseline.

  7. Change from baseline - H-reflex test

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

    Electrophysiologic evaluation of the reflex response triggered on the motor nerves when sensory fibers in the peripheral nerve are stimulated.

  8. Change from baseline - Somatosensory evoked potentials test

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

    Electrophysiologic evaluation of sensory pathways between the brain and the limb.

  9. Change from baseline - Spinally evoked motor potentials test

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

    Electrophysiologic evaluation of motor pathways between the central nervous system and the muscles.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma Inanici

CONTACT

[email protected]

206-787-2692

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Acronym: HARNESS

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 24, 2022
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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