Implanted device may loosen Stroke-Related muscle stiffness
NCT ID NCT07744659
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This trial tests whether spinal cord stimulation (SCS) can reduce muscle spasticity in adults who have had a stroke. Participants will have a small device implanted that sends electrical pulses to the spinal cord. Half will receive active stimulation for six weeks, while the other half gets a sham (inactive) treatment. After that period, everyone receives active stimulation. The study measures changes in muscle stiffness, movement, and quality of life over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Spinal cord stimulation (SCS) via an implanted device
- What this could lead to
- If effective, this could offer a new way to reduce muscle stiffness and improve movement and daily function in people living with post-stroke spasticity.
- What could go wrong
- This is an early-stage trial with a modest number of participants, and the results may not apply to everyone. The procedure involves surgery and device implantation, which carry risks such as infection or device-related problems.
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
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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 92 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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18 to 75 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. Aged ≥18 years and \<75 years, regardless of sex; 2. Diagnosed with ischemic or hemorrhagic stroke, with unilateral or single-limb motor dysfunction persisting for at least 6 months; 3. The primary brain lesion and its underlying cause are clinically stable; 4. Presence of unilateral upper- or lower-limb spasticity, with a Modified Ashworth Scale (MAS) grade of ≥2 in at least two muscle groups of the affected limb; 5. Post-stroke limb dysfunction has not reached the treatment goal despite previous interventions, such as physical therapy and oral medications, and the participant's condition has shown no recent improvement; 6. The type and dose of existing rehabilitation therapy and oral antispastic medications must remain unchanged during the study; 7. Willing and able to complete all study visits and procedures; 8. Able to understand the study and provide written informed consent. Exclusion Criteria: 1. Any contraindication to spinal cord stimulation surgery; 2. Uncontrolled refractory epilepsy; 3. Presence of tonic spasticity, such as decorticate rigidity or decerebrate rigidity; 4. Poorly controlled severe psychiatric or cognitive impairment, defined as a Beck Depression Inventory-II score \>25 or a Mini-Mental State Examination score \<24; 5. Active systemic infection; 6. Presence of an implanted neurostimulator or drug delivery system; 7. Botulinum toxin treatment within 4 months before enrollment; 8. Plans to initiate any new treatment during the study that may affect limb movement, including chemical denervation therapies (such as botulinum toxin), oral antispastic medications, surgical procedures (such as peripheral neurotomy or contralateral C7 nerve transfer), or other physical therapy interventions; 9. Pregnancy, breastfeeding, or planned pregnancy during the study; 10. The participant or family is unable or unwilling to participate in long-term SCS treatment management; 11. Participation in another clinical study within 4 weeks before signing informed consent; 12. Any other condition that, in the investigator's judgment, makes the individual unsuitable for participation in the study.
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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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China-Japan Friendship Hospital
Beijing, China
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