SCI - Spinal Cord InjuryNCT07890558
Addressing Spasticity and Motor Function With Epidural Spinal Cord Stimulation
A study testing Epidural implant stimulation device in people with SCI - Spinal Cord Injury and Spasticity, run by Kessler Foundation at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- SCI - Spinal Cord Injury, Spasticity
- What is being tested?
- Epidural implant stimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Mar 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 22 years of age
- Post 1 year non-progressive SCI
- Stable medical condition (cleared by the study physician and do not have any medical conditions that would interfere with study procedures)
- Diagnosed with and treated for severe spasticity at least 6 months ago
Who cannot join
- ventilator dependent
- untreated painful musculoskeletal dysfunction, fracture or pressure injury
- untreated psychiatric disorder or ongoing drug abuse
- cardiac, respiratory, bladder, renal or other untreated medical disorder unrelated to SCI
- 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
- colostomy bag, urostomy
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- Any active implantable devices or implanted pump (such as a baclofen pump, pain pump, etc.)
- pregnant at the time of enrollment or planning to become pregnant during the time course of the study
- Contraindications to MRI imaging (e.g., pacemaker, metallic foreign body, aneurysm clip)
- 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)
- Severe muscle contractures
- unable to operate a touch screen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Research Manager, 973-324-3557, LMartinez@KesslerFoundation.Org
Gail F Forrest, PhD
About this study
Official title: Pilot Study: Addressing Spasticity and Motor Function With Epidural Spinal Cord Stimulation
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.
Read the detailed description
This study aims to expand our knowledge and capacity for neuromodulation to improve the debilitating effects of severe spasticity (spasms, tonic muscle activity and/or clonus) in persons with spinal cord injury (SCI) who are not adequately treated with oral pharmacological management, while avoiding side effects, and also improving voluntary control using surgically implantable targeted tonic spinal cord epidural stimulation (scES). Individuals recruited and enrolled in the study will have significant spasticity not adequately treated by oral medications. Current treatment of severe spasticity by pharmacological treatments are associated with several concomitant side effects that have consequences including limiting the ability to participate in and respond to neurorehabilitation and diminishing quality of life. Also, for persons with SCI and severe spasticity, available rehabilitation therapies are limited in their ability to foster appropriate neural excitation and subsequently motor recovery.
This study focuses on ameliorating severe spasticity through specific spasticity-targeted spinal cord epidural stimulation (SP-scES) that has been shown to mediate levels of neural excitation for movement and unwanted muscle activation. In the long-term, this study will also provide a framework to develop clinically viable approaches with tools to provide optimized care for individuals with chronic SCI. This research is directly aimed to improve the quality of life for those affected by and living with SCI by reducing spasticity (and increasing voluntary control of movement) in the home and community.
Participants will be asked to undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to find the specific stimulation configurations for their spasticity. The intervention portion of the study consists of using the stimulator at home and/or in the training facility and completing assessments. Participants will return for follow-up assessments at 3- and 6-months post-intervention. At the conclusion of the study, participants can choose to have the stimulator removed, turned off, or continue using it at home for spasm management.
- Conditions
- SCI - Spinal Cord Injury, Spasticity
- Being tested
- Epidural implant stimulation device
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural implant stimulation deviceDevice
Participants will undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to identify targeted stimulation configurations for spasticity.
| Study group | Role | What they receive |
|---|---|---|
| Surgically implanted epidural stimulation for spasticity | Experimental | 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. Receives: Device: Epidural implant stimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of muscle Activity Using Integrated EMG in Response to Triggered Spasticity
Three common triggers of spasticity for each person will be identified, such as quick stretch of the ankle, flexion/extension of the hip, and rapid position changes. Each trigger will be implemented consecutively three times while recording EMG from the hip, knee, and ankle muscles bilaterally. The EMG data will be full wave rectified and filtered using a 4th order bandpass Butterworth filter (40 Hz - 500 Hz) representing the relative number and frequencies of the motor units recruited per burst. Integrated EMG will assess the total EMG activity generated in response to the spasticity trigger for each muscle for each attempt. Muscles: (SOL), medial gastrocnemius (MG), tibialis anterior (TA), medial hamstrings (MH), quadriceps (VL and RF), adductor (AD) and/or other related muscles.
Measured: 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.
Secondary outcomes (6)
The Penn Spasm Scale
The Penn Spasm Scale is a 2-part self-report noting both the severity and frequency of spasms. Frequency is a 0-4 scale with 0 being no spasms and 4 being more than 10 spasms per hour. Severity is a 1-3 scale with 1 being mild, 2 is moderate and 3 is severe. Severity is not measured if frequency is 0.
Measured: 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.
Modified Ashworth Score
Modified Ashworth Score assesses on a scale of 0 to 4 the resistance of a relaxed, single joint as it is moved throughout its full available range of motion. Participants will be instructed to relax and to allow the examiner to perform the test movement. A zero indicates the area moves freely with no resistance, while a 4 indicates the area is rigid and cannot move.
Measured: 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.
Frequency of Side Effects
Participants will report subjective experiences of side effects including fatigue, drowsiness, dizziness, weakness, confusion, headache, nausea, and sexual dysfunction. STIMX PICS algorithms will be recorded using temporaneous recording of each effect and its duration at the time of each experience.
STIMX PICS recordings (subjective frequency of side effects) will occur for 24 hours twice prior to implantation and weekly after surgery throughout the 3 months of intervention.
Measured: 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.
Quantification of Muscle Activity Using Integrated EMG in Response to Voluntary Leg Movement
Hip and knee extension and flexion and ankle dorsi and plantar flexion will be attempted consecutively three times in response to a 3 tone while recording EMG from the hip, knee, and ankle muscles bilaterally. The EMG data will be full wave rectified and filtered using a 4th order bandpass Butterworth filter (40 Hz - 500 Hz) representing the relative number and frequencies of the motor units recruited per burst.
Measured: 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.
NeuroRecovery Scale (NRS) for Lower Body and Trunk
The NRS is a valid, reliable, and responsive evaluation tool for measuring functional recovery in persons with SCI based on tasks that test pre-injury functional capability. It uses a 12-item scale focusing on lower extremity and trunk function including sit up, sit, reverse sit up, trunk extension in sitting, and stand with a maximum score of 72 points, which represents full recovery of pre-injury function, and minimum score of 0 points, which represents no change in functional recovery.
Measured: 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.
The AIS Impairment Scale
The ASIA Impairment Scale (AIS) is a classification in SCI that describes the level and severity of the injury, based upon the motor and sensory examination as described in the International Standards of Neurological Classification for SCI (ISNCSCI). This scale ranges from A-E, with A being complete (no motor or sensory function) and E being normal (no sensory or motor impairment)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gail Forrest, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890558
- Sponsor's protocol ID
- R-1309-25
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No