RecruitingNot ApplicableNCT06515223

Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury


Sponsor

University College, London

Enrollment

20 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators will recruit up to 20 volunteers with chronic, supra-sacral SCI. Following screening, eligible participants will enter 'Phase I', they will complete baseline outcome measures and then have the epidural spinal cord stimulator (eSCS) implanted with either percutaneous or paddle electrodes. Preoperative and intraoperative testing will determine exact location of electrodes. Mapping and optimisation of stimulation parameters will be performed simultaneously with urodynamic investigations of bladder function, and anorectal physiology investigations of bowel function. The acute effects of eSCS to suppress bladder overactivity, facilitate voiding, prevent unwanted reflex sphincter activity, and pelvic floor function will guide development of eSCS programmes for use at home. In 'Phase II', participants will use eSCS at home for 12-weeks. Participants will also be taught how to perform bladder and pelvic floor muscle training (PFMT) in combination with eSCS. Outcome measures assessing bladder, bowel, sexual function, quality of life, motor function and spasticity will be captured prior to and following the 12-week intervention, and at 3 and 6 month follow up.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Epidural Spinal Cord Stimulation for people with neurogenic bladder, neuromodulation, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEpidural Spinal Cord Stimulation

Epidural Spinal Cord Stimulation Mapping and Pelvic Floor Muscle Training


Locations(1)

Royal National Orthopaedic Hospital

Stanmore, United Kingdom

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NCT06515223


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