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Pilot study: addressing spasticity and motor function with epidural spinal cord stimulation

NCT ID NCT07890558

Sponsor: Kessler Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 22, 2026 · Last updated Oct 23, 2026 · Updated 1 time

Summary

The purpose of this study is to investigate treating severe spasticity in persons with spinal cord injury by implanting a device in the body that delivers electrical stimulation around the spinal cord (spinal cord epidural stimulation). This study will be closely monitoring a program designed to treat spasticity using an epidural stimulator to better understand its effects on spasticity and voluntary movement.

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 8 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

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

22 years and older

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. At least 22 years of age 2. Post 1 year non-progressive SCI 3. Stable medical condition (cleared by the study physician and do not have any medical conditions that would interfere with study procedures) 4. Diagnosed with and treated for severe spasticity at least 6 months ago Exclusion Criteria: 1. ventilator dependent 2. untreated painful musculoskeletal dysfunction, fracture or pressure injury 3. untreated psychiatric disorder or ongoing drug abuse 4. cardiac, respiratory, bladder, renal or other untreated medical disorder unrelated to SCI 5. Botulinum toxin injections (such as Botox) or other injections to manage spasms (such as phenol or alcohol) in any muscle or bladder less than 6 months prior to implant 6. colostomy bag, urostomy 7. Any active implantable devices or implanted pump (such as a baclofen pump, pain pump, etc.) 8. pregnant at the time of enrollment or planning to become pregnant during the time course of the study 9. Contraindications to MRI imaging (e.g., pacemaker, metallic foreign body, aneurysm clip) 10. Imaging findings that determine the area of spine the stimulation device would be implanted is not suitable for surgery (such as implanted hardware interference or additional deterioration/injury of spinal cord at or below the region) 11. Severe muscle contractures 12. unable to operate a touch screen

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Conditions

The condition(s) this trial relates to.

Muscle Spasticity spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sci - spinal cord injury Spasticity

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

  • Kessler Foundation

    RECRUITING

    West Orange, New Jersey, 07052, United States

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