"Epidural Spinal Cord Stimulation: Addressing Spasticity and Motor Function"

NCT05422716 | Not Yet Recruiting

• 1 other identifier: R-1176-22
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spasticity

Outcome Measures

Primary Outcomes (1)

• 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. 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.

  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 (6)

• The Penn Spasm Scale

  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)

• Modified Ashworth Score

  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)

• Frequency of Side Effects

  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)

• Quantification of Muscle Activity Using Integrated EMG in Response to Voluntary Leg Movement

  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)

• NeuroRecovery Scale (NRS) for Lower Body and Trunk

  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)

Study Arms (2)

Surgically implanted epidural stimulation for spasticity

EXPERIMENTAL

The epidural stimulation (ES) group will undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to identify targeted stimulation configurations for spasticity. In each subsequent 6 months we will enroll cohorts of (n=5) voluntary research participants to allow for the final cohort to complete their 6 month follow up with a remaining 3 months for final data analyses and dissemination for the grant period. 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

Surgically implanted Intrathecal baclofen pump, the standard of care control group

EXPERIMENTAL

Individuals randomized to the baclofen pump (BP) group will continue with their clinical surgical and maintenance plan while also participating in all of the outcomes (assessments). The Baclofen pump will be surgically implanted by a member of the clinical SCI medical team.

Device: Epidural implant stimulation device

Interventions

Epidural implant stimulation device DEVICE

Individuals randomized to the Baclofen pump device group will continue with their clinical surgical and maintenance plan while also participating in all of the outcomes (assessments). The epidural implant group will undergo the research protocol for epidural stimulator surgical implant followed by mapping studies to identify targeted stimulation configurations for spasticity.

Also known as: Baclofen Pump device

Surgically implanted Intrathecal baclofen pump, the standard of care control group; Surgically implanted epidural stimulation for spasticity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kessler Foundation: lead

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: participants will be randomized into either the baclofen group or epidural stimulation

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: June 16, 2022
• Study Start: July 14, 2022
• Primary Completion: May 15, 2026
• Study Completion: May 15, 2026
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share