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Implanted device may loosen Stroke-Related muscle stiffness

NCT ID NCT07744659

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
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 Results may not be published yet.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)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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 92 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 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. 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.

Muscle Spasticity stroke disorder

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • China-Japan Friendship Hospital

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.