Spinal zap plus therapy may restore arm movement in stroke survivors

NCT ID NCT07153536

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Recruiting now This study
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a spinal cord stimulator, combined with physical therapy, can help people who have had a stroke regain arm and hand movement. Twenty adults with long-term arm weakness will first do therapy alone, then get a spinal implant and repeat therapy with stimulation. The goal is to see if the stimulation is safe and improves motor control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Experienced an ischemic or hemorrhagic stroke that resulted in arm and hand hemiparesis more than 6 months prior to the time of enrollment (Prior strokes that did not cause upper extremity motor deficits are not exclusionary.) 2. Age 22 to 70 years old 3. Upper extremity motor score higher than 20 and lower than or equal to 45 on the Fugl-Meyer Assessment (FMA) scale 4. FMA upper extremity sensory score higher than 6 points (out of 12 points) 5. The ability to communicate, understand, give appropriate consent and follow two-step commands Exclusion Criteria: 1. Presence of any serious disease or disorder (ex. Neurological conditions other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) that could affect their ability to participate in this study 2. Considered to be at high-risk of recurrent stroke as evident from their medical history or upon judgment of the study physician 3. Presence of post-stroke central pain, other forms of pain or other constraints such as joint contractures in the paretic arm that are serious enough to prevent or affect the correct execution of the physical training protocol as judged by the study therapist 4. A score on the Short Blessed Test assessment scale lower than 9 5. Female participants of child-bearing age who are pregnant or breastfeeding during the study 6. Participants that cannot suspend their antiplatelets and/or anticoagulant therapy for two weeks around the time of surgery 7. Existence of any implanted medical device that is not MRI safe and/or any active medical devices even if it is MRI safe 8. Implanted spinal fusion and stabilization devices such as plates and rods between the C2 and T3 spinal vertebra 9. Obstructed or restricted epidural spinal canal to the point of hindering or increasing the risk of implant of the spinal leads as judged by the study surgeon upon screening imaging 10. Severe claustrophobia that prevents execution of the required MRI imaging sessions 11. Taking anti-spasticity or anti-epileptic medications 12. T-score higher than 63 on the 18-question Brief Symptoms Inventory (BSI-18) who have undergone discussions with and been deemed unsuitable by the Principal Investigator and a study physician Potential participants who may be excluded on initial screening may discuss possible medication changes with their physician.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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  3. A doctor treating you

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Contacts and locations

Locations

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

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