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Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury

NCT06515223 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-14

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injuries
  • Neuromodulation
  • Neurogenic Bladder
  • Neurogenic Bowel
  • Neurogenic Detrusor Overactivity

Interventions

DEVICE

Epidural Spinal Cord Stimulation

Epidural Spinal Cord Stimulation Mapping and Pelvic Floor Muscle Training

Sponsors & Collaborators

  • Royal National Orthopaedic Hospital NHS Trust

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • David Baxter, MD · National Health Service, United Kingdom

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-14
Primary Completion
2027-01-01
Completion
2027-11-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06515223 on ClinicalTrials.gov