An interventional study of Epidural implant stimulation device in SCI - Spinal Cord Injury and Spasticity, sponsored by Kessler Foundation. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment
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 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.
1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.
This study's planned enrollment of 8 is below the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Kessler Foundation is the lead sponsor of 174 studies on the registry; 60 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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.
Device: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
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.
Plan to share: No
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Start is estimated for Oct 2026; primary completion for Jan 2029, 27 months later.
Of 766 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 27 months is below that.
Counting every sponsor, half of 816 studies reached it within 35 months; a quarter within 16 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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