Actively Recruiting
Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis
Led by Marco Capogrosso · Updated on 2026-05-08
20
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
Sponsors
M
Marco Capogrosso
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study plans to use systems that have been developed by Medtronic to investigate the use of cervical spinal cord stimulation to treat adults with upper limb hemiparesis resulting from a stroke. The spinal cord stimulation (SCS) will be combined with physical training to improve arm and hand motor control. The study is divided into three phases. In the first phase, after baseline assessments, participants will undergo a Physical Training Protocol (PTP) for 6 weeks including 3 sessions of 90 mins/session per week. After receiving the Medtronic implantable system, in Phase 2, they will then repeat the same PTP program in combination with spinal cord stimulation during the entirety of each of the rehabilitation sessions. Finally, in Phase 3, participants will go home, will not be able to use the stimulation at home but will participate in monthly assessments in the laboratory in which the functionality of the Medtronic system and their motor performances will be assessed for up to 6 months.
CONDITIONS
Official Title
Spinal Cord Stimulation Combined With Physical Therapy in Post-Stroke Upper-Limb Motor Hemiparesis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Experienced an ischemic or hemorrhagic stroke causing arm and hand weakness more than 6 months before enrolling
- Age between 22 and 70 years old
- Upper extremity motor score greater than 20 and up to 45 on the Fugl-Meyer Assessment scale
- Upper extremity sensory score above 6 points out of 12 on the Fugl-Meyer Assessment scale
- Ability to communicate, understand, consent, and follow two-step commands
You will not qualify if you...
- Having serious diseases or disorders such as neurological conditions besides stroke, cancer, severe heart or lung disease, or kidney failure that affect participation
- High risk of another stroke based on medical history or physician judgment
- Severe post-stroke pain or joint problems in the affected arm preventing proper physical training
- Scoring below 9 on the Short Blessed Test for cognitive function
- Pregnant or breastfeeding females of child-bearing age
- Inability to stop antiplatelet or anticoagulant medications for two weeks around surgery
- Having implanted medical devices that are not MRI safe or other active medical devices
- Presence of spinal fusion or stabilization devices from the C2 to T3 vertebrae
- Narrowed or obstructed epidural spinal canal increasing risk of spinal lead implantation
- Severe claustrophobia interfering with MRI scans
- Use of anti-spasticity or anti-epileptic medications
- High psychological symptom score (T-score >63) on the Brief Symptoms Inventory and deemed unsuitable by study physicians
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
A
Amy Boos, MS
CONTACT
C
Cierra Clark, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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