Clinical trial NCT05422716: "Epidural Spinal Cord Stimulation: Addressing Spasticity and Motor Function"
Official title: "Epidural Spinal Cord Stimulation: Addressing Spasticity and Motor Function"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spasticity
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants will be randomized into either the baclofen group or epidural stimulation
Primary purpose: TREATMENT

Brief summary: This study aims to expand the 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). The purpose of this study is to compare if spinal cord epidural stimulation can treat severe spasticity more effectively and have fewer side effects than a baclofen pump.

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 and clinically referred for an intrathecal baclofen pump trial. 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 neurorehabilitation15 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. The study will be evaluated as compared to a standard of care control group using pharmacological administration via an intrathecal baclofen pump (ITBP). 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 while avoiding debilitating side effects of long-term pharmacological intervention.

Eligibility criteria: Inclusion Criteria:

1. I must be at least 18 years of age
2. I must have a non-progressive spinal cord injury (SCI)
3. I have met the clinical criteria for an intrathecal baclofen pump
4. I am in stable medical condition

Exclusion Criteria:

1. I must not be ventilator dependent
2. I must not have untreated painful musculoskeletal dysfunction, fracture or pressure injury
3. I must not have untreated psychiatric disorder or ongoing drug abuse, as determined by study staff
4. I must not have cardiac, respiratory, bladder, renal or other untreated medical disorder unrelated to SCI
5. I must not have had peripheral muscle Botox injections less than 12 months prior to implant
6. I must not have a colostomy bag or urostomy
7. I must not have any implanted pump (i.e., baclofen pump, pain pump, etc.) prior to randomization
8. I must not be pregnant at the time of enrollment or planning to become pregnant during the time course of the study
9. I must not have an active implantable device that may interfere with the epidural neurostimulator

Primary outcomes:
measure: Quantification of muscle Activity Using Integrated EMG in Response to Triggered Spasticity
timeFrame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
Secondary outcomes:
measure: The Penn Spasm Scale
timeFrame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
measure: Modified Ashworth Score
timeFrame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
measure: Frequency of Side Effects
timeFrame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
measure: Quantification of Muscle Activity Using Integrated EMG in Response to Voluntary Leg Movement
timeFrame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
measure: NeuroRecovery Scale (NRS) for Lower Body and Trunk
timeFrame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
measure: The AIS Impairment Scale
timeFrame: Baseline assessment through study completion, an average of 8 months. Assessments will be preformed: prior to being implanted and 3 months and 6 months after implantation)
Other outcomes:
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