Recruiting

Epidural Stimulation

Sponsor:

Kessler Foundation

Code:

NCT07890558

Conditions

SCI - Spinal Cord Injury

Spasticity

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Epidural implant stimulation device

Study Details

Brief 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.

Conditions

SCI - Spinal Cord Injury

Spasticity

Study ID

NCT07890558

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Jan 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Surgically implanted epidural stimulation for spasticity

Participants will undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to identify targeted stimulation configurations for spasticity.

Spinal cord epidural stimulation is administered by a multi-electrode array implanted in the epidural space over the dorsum of the spinal cord.

Interventions

Epidural implant stimulation device

Participants will undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to identify targeted stimulation configurations for spasticity.

Primary outcome measure

  • Quantification of muscle Activity Using Integrated EMG in Response to Triggered Spasticity [ Time Frame: Baseline assessment through study completion, an average of 11 months. Assessments will be performed: prior to being implanted and 3 months and 6 months after implantation, mapping, and device training. ]

Central Contacts and Locations

Central contacts

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Principal Investigator:

Gail F Forrest, PhD

More Information

Sponsor

Kessler Foundation

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.