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

Primary Purpose

Stroke, Ischemic, Chronic Stroke

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Non-invasive Electrical Spinal Cord Stimulation

Activity Based Rehabilitation

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Chronic ischemic stroke, Transcutaneous spinal cord stimulation, Activity based rehabilitation

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of WashingtonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Activity Based Rehabilitation

Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation

Arm 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).

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).

Outcomes

Primary Outcome Measures

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.

Change from baseline - Pinch and grip force

Measurement of hand strengths using a dynamometry.

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.

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.

Secondary Outcome Measures

Change from baseline - Action Research Arm Test

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

Change from baseline - Box and Blocks Test

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.

Change from baseline - Revised Nottingham Sensory Assessment

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

Change from baseline - Stroke Impact Scale

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.

Change from baseline - Short Form-36

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

Change from baseline - Patients Global Impression of Change

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.

Change from baseline - H-reflex test

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

Change from baseline - Somatosensory evoked potentials test

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

Change from baseline - Spinally evoked motor potentials test

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

Full Information

NCT ID

NCT05591196

First Posted

October 13, 2022

Last Updated

October 18, 2022

Sponsor

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT05591196

Brief Title

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

Acronym

HARNESS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Ischemic, Chronic Stroke

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Activity Based Rehabilitation

Arm Type

Active Comparator

Arm Description

Arm Title

Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Non-invasive Electrical Spinal Cord Stimulation

Intervention Description

Electrical stimulation of the spinal cord using surface electrodes

Intervention Type

Other

Intervention Name(s)

Activity Based Rehabilitation

Intervention Description

Exercise therapy targeting paralyzed hand and arm

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

Change from baseline - Pinch and grip force

Description

Measurement of hand strengths using a dynamometry.

Time Frame

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

Title

Change from baseline - Modified Ashworth Scale

Description

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.

Time Frame

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

Title

Change from baseline - Wolf Motor Function Test

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Change from baseline - Action Research Arm Test

Description

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

Time Frame

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

Title

Change from baseline - Box and Blocks Test

Description

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.

Time Frame

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

Title

Change from baseline - Revised Nottingham Sensory Assessment

Description

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

Time Frame