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

NCT ID: NCT05422716

Last Updated: 2022-06-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-14
• Study Completion Date: 2026-05-15

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.

Conditions

Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgically implanted epidural stimulation for spasticity

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.

Group Type: EXPERIMENTAL

Epidural implant stimulation device

Intervention Type: 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.

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

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.

Group Type: EXPERIMENTAL

Epidural implant stimulation device

Intervention Type: 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.

Interventions

Epidural implant stimulation 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.

Intervention Type: DEVICE

Other Intervention Names

Baclofen Pump device

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

R-1176-22

Identifier Type: -

Identifier Source: org_study_id