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NOT YET RECRUITING
NCT05422716
NA

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

Sponsor: Kessler Foundation

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-07-14

Completion Date

2026-05-15

Last Updated

2022-06-16

Healthy Volunteers

No

Conditions

Interventions

DEVICE

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.