Stroke, IschemicHARNESSNCT05591196

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

A study testing Non-invasive Electrical Spinal Cord Stimulation and Activity Based Rehabilitation in people with Stroke, Ischemic and Chronic Stroke, run by University of Washington at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 21 to 80 years
Conditions the study is for: Stroke, Ischemic, Chronic Stroke, Hemorrhagic Stroke
What is being tested?: Non-invasive Electrical Spinal Cord Stimulation and Activity Based Rehabilitation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2022to 31 Dec 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 13Show fewer

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fatma Inanici contact

206-787-2692

finanici@uw.edu

United States1 site, 1 recruiting

University of Washington
Seattle, Washington, 98105
Fatma Inanici, MD, Ph.D., 2067872692, finanici@uw.edu
Fatma Inanici, MD, PhD
Recruiting

Other trials in United States

About this study

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.

Conditions: Stroke, Ischemic, Chronic Stroke, Hemorrhagic Stroke
Being tested: Non-invasive Electrical Spinal Cord Stimulation, Activity Based Rehabilitation
Keywords: Chronic ischemic stroke, Transcutaneous spinal cord stimulation, Activity based rehabilitation
Medical subject headings: Ischemic Stroke, Hemorrhagic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Non-invasive Electrical Spinal Cord StimulationDevice
Electrical stimulation of the spinal cord using surface electrodes
Activity Based RehabilitationOther
Exercise therapy targeting paralyzed hand and arm

Study groups in NCT05591196
Study group	Role	What they receive
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). Receives: 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). Receives: Device: Non-invasive Electrical Spinal Cord Stimulation; Other: Activity Based Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: "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.
Measured: "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.
Measured: "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.
Measured: "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
Clinician-administered observational measure to assess upper extremity performance, such as coordination, dexterity, and functioning, in stroke recovery.
Measured: "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
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.
Measured: "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
A standardized scale for assessing sensory impairment in stroke patients. Tactile sensation, proprioception, stereognosis, and two-point discrimination are evaluated.
Measured: "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
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.
Measured: "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
A self-report health survey questionnaire. The score range from 0 to 100. The higher the score, the better the outcome.
Measured: "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 - 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.
Measured: "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 - H-reflex test
Electrophysiologic evaluation of the reflex response triggered on the motor nerves when sensory fibers in the peripheral nerve are stimulated.
Measured: "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 - Somatosensory evoked potentials test
Electrophysiologic evaluation of sensory pathways between the brain and the limb.
Measured: "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 - Spinally evoked motor potentials test
Electrophysiologic evaluation of motor pathways between the central nervous system and the muscles.
Measured: "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months."

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202231 Dec 2027

First posted24 Oct 2022
Study start1 Oct 2022
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stroke, IschemicStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
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)
Enrolment: 6 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05591196
Sponsor's protocol ID: STUDY00015990
Acronym: HARNESS
Status last verified: Oct 2026
First submitted: 13 Oct 2022
Last updated: 4 Nov 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Interested in taking part?

Fatma Inanici

206-787-2692

finanici@uw.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Not yet recruiting
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All Stroke, Ischemic trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke
ClinicalTrials.gov ID: NCT05591196
Acronym / sponsor ID: HARNESS / STUDY00015990
Conditions: Stroke, Ischemic, Chronic Stroke, Hemorrhagic Stroke
Keywords: Chronic ischemic stroke, Transcutaneous spinal cord stimulation, Activity based rehabilitation
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 6 participants (estimated)
Lead sponsor: University of WashingtonUniversity, hospital or other
Study start: 1 Oct 2022 (actual)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 24 Oct 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Activity Based Rehabilitation	Active comparator	Other: Activity Based RehabilitationActivity 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 + Activity Based Rehabilitation	Experimental	Device: Non-invasive Electrical Spinal Cord Stimulation, Other: Activity Based RehabilitationNon-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).

Who may qualify

Ages: 21 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Non-invasive Electrical Spinal Cord StimulationElectrical stimulation of the spinal cord using surface electrodes	Device	Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation
Activity Based RehabilitationExercise therapy targeting paralyzed hand and arm	Other	Activity Based Rehabilitation, Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation

Primary outcome

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.
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.
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.
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.

9 secondary outcomes

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."
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."
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."
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."
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."
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."
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."
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."
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."

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.

Related trials for Stroke, Ischemic

Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
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Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
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A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
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Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Fatma Inanici contact

206-787-2692

finanici@uw.edu

Chet Moritz, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fatma Inanici (206-787-2692, finanici@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05591196.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.