Targeted spinal cord stimulation to reduce spasticity in spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial investigates the safety and potential benefits of a surgically implanted epidural spinal cord stimulation device to treat severe spasticity in people with chronic spinal cord injury. Participants receive targeted tonic stimulation around the spinal cord and are monitored for changes in spasticity and voluntary motor control, with the goal of improving function and quality of life. Recruitment is limited to adults with stable, non-progressive SCI and inadequately controlled spasticity despite other treatments. The study emphasizes careful medical screening, device considerations, and follow-up assessments to understand the neuromodulation effects and potential rehabilitation gains.

Why it matters

Who can join: the full rules

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

Where it's running

• Kessler Foundation
  West Orange, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Research Manager
• Email: LMartinez@KesslerFoundation.Org
• Phone: 973-324-3557

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Shockwave therapy added to toxin injections to help spasticity after spinal cord injury

  Aims to see if focused shockwave therapy plus Botox injections reduce spasticity better than Botox alone in adults with spinal cord injury.

  Recruiting Phase 2 Kessler Foundation · West Orange, New Jersey · NCT07894991

• Photobiomodulation to Help Spasticity After Stroke

  This trial tests whether matching low-level light therapy can reduce leg muscle tightness in adults who have had a stroke and developed spasticity.

  Recruiting Phase 1/2 University of Nove de Julho · São Paulo, São Paulo · NCT07784231

• Dorsal Root Electrical Stimulation to Help Spasticity in Children with Cerebral Palsy

  This study tests whether adding dorsal root electrical stimulation during SDR surgery can lessen spasticity in children with cerebral palsy.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07715006

• Cryoneurolysis for Chronic Pain: 6- and 12-Month Outcomes in Routine Care

  This study tests whether cryoneurolysis, done as part of standard care for people with chronic pain, leads to meaningful improvements over 6 to 12 months.

  Recruiting Yale University · Old Saybrook, Connecticut · NCT07639060

• Gentle spinal stimulation to reduce muscle tightness in children with cerebral palsy

  This will try non-invasive, light spinal cord stimulation with movement tests to see if it reduces spasticity in children ages 5–17 with cerebral palsy.

  Recruiting University of Pittsburgh · Pittsburgh, Pennsylvania · NCT07516067

• Spinal cord stimulation for bladder and bowel problems after spinal cord injury

  This project will test spinal cord stimulation to see if it helps people with bladder and bowel problems after a spinal cord injury.

  Recruiting Beijing Tsinghua Chang Gung Hospital · Beijing · NCT07511244

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.