Cervical spinal cord stimulation plus physical therapy for chronic post-stroke arm weakness

Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis

This study will test whether adding cervical spinal cord stimulation to physical therapy helps adults with chronic arm and hand weakness after a stroke move and use their arm better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 22 Years to 70 Years
• Sex: All
• Sponsor: University of Pittsburgh (other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT07153536 on ClinicalTrials.gov

What this trial studies

Researchers will enroll adults 22–70 with chronic (≥6 months) upper-limb hemiparesis after ischemic or hemorrhagic stroke and moderate impairment on the Fugl‑Meyer scale. Participants first complete a six-week physical training program (three 90‑minute sessions per week) to establish a rehabilitation plateau. Those who proceed receive a Medtronic implantable cervical spinal cord stimulator and then repeat the same physical training with stimulation active during each rehabilitation session. After the in‑clinic rehabilitation phase, participants return home without home stimulation and attend monthly lab assessments for up to six months to monitor safety and motor performance.

Who should consider this trial

Good fit: Adults aged 22–70 with chronic (≥6 months) unilateral arm/hand weakness after stroke, moderate motor impairment (FMA-UE >20 to ≤45), sufficient upper-limb sensation, and the ability to follow two-step commands.

Not a fit: People with very mild or very severe arm impairment, active serious medical or neurological illnesses, high risk of recurrent stroke, or post-stroke central pain are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If successful, the approach could improve arm and hand function and reduce long-term disability for people with chronic post-stroke hemiparesis.

How similar studies have performed: Small pilot studies and case reports of cervical or epidural spinal cord stimulation combined with rehabilitation have shown encouraging motor gains, but large randomized trials are still lacking.

Eligibility criteria

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.

Where this trial is running

Pittsburgh, Pennsylvania

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: George Wittenberg, MD, PhD — University of Pittsburgh
• Study coordinator: Amy Boos, MS

Conditions: Stroke, Spinal Cord Injuries and Disorders, Hemiparesis After Stroke, spinal cord stimulation