Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Spinal Cord Injury (supra-sacral)

• AIS A-D

• \>18 years;

• SCI sustained \>12 months ago;

• Neurogenic detrusor overactivity (NDO) confirmed on urodynamics;

• Responsive to dorsal genital nerve stimulation

• Willing and able to provide informed consent

• Stable medical, physical and psychological condition as considered by the investigators

• Able to understand and interact with the study team in English

• Sufficient upper limb function to operate the device

• Suitably optimised bladder and bowel routine

Locations
Other Locations
United Kingdom
Royal National Orthopaedic Hospital
RECRUITING
Stanmore
Contact Information
Primary
Lynsey Duffell, PhD
l.duffell@ucl.ac.uk
0208 385 3787
Backup
Hannah Houliston, PhD
hannah.houliston@nhs.net
02039470291
Time Frame
Start Date: 2024-10-14
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 20
Treatments
Experimental: Treatment
Implantation of Epidural Spinal Cord Stimulation to target bladder and bowel function. Applied in combination with Pelvic Floor Muscle Training.
Sponsors
Leads: University College, London
Collaborators: Royal National Orthopaedic Hospital NHS Trust

This content was sourced from clinicaltrials.gov