Spinal zap plus therapy may restore arm movement in stroke survivors
NCT ID NCT07153536
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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22 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Pittsburgh
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Effects of transcranial direct current stimulation and pelvic proprioceptive neuromuscular facilitation on trunk control, balance and functional mobility in stroke patients
- Correlation of visual and motor deficits in stroke patients
- Pilot study on the effects induced by an electromyographic-controlled functional electrical stimulator (FitFES) for upper limb rehabilitation in post-stroke patients
- Brazilian version of a behavior change intervention to support healthy lifestyle adoption after stroke - iVIDAVC: protocol for a pilot randomized study
- Determination of efficacy of sustained motor contraction generated using StimWave peripheral nerve stimulator
- Can a PET tracer reveal hidden brain inflammation?