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

University of Washington

Status: Enrolling

Conditions: Chronic Stroke; Stroke, Ischemic

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05591196

STUDY00015990

Details and patient eligibility

About

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Activity Based Rehabilitation

Active Comparator group

Description:

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).

Treatment:

Other: Activity Based Rehabilitation

Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation

Experimental group

Description:

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).

Treatment:

Device: Non-invasive Electrical Spinal Cord Stimulation

Other: Activity Based Rehabilitation