NCT06515223 Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
| NCT ID | NCT06515223 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College, London |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-10-14 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Transected cord or SCI related to a neurodegenerative disease * Any device or metal work in situ that would exclude the patient from having eSCS implanted * Intra-detrusor botulinum toxin injections within the last 6 months * Previous surgical intervention on bladder sphincters * Any diseases and conditions that would exclude the patient from eSCS and/or surgery, for example, degenerative spinal pathology, syrinx and/or tumor. * Recurrent urinary tract infection refractory to antibiotics * Women who are pregnant or intending to become pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding, or lack of safe contraception for women of childbearing capacity. * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant * Participation in another study with investigational drug within the 30 days preceding and during the present study * Enrolment of the investigator, his/her family members, employees, and other dependent persons.
Contact & Investigator
David Baxter, MD
PRINCIPAL INVESTIGATOR
National Health Service, United Kingdom
Frequently Asked Questions
Who can join the NCT06515223 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06515223 currently recruiting?
Yes, NCT06515223 is actively recruiting participants. Contact the research team at l.duffell@ucl.ac.uk for enrollment information.
Where is the NCT06515223 trial being conducted?
This trial is being conducted at Stanmore, United Kingdom.
Who is sponsoring the NCT06515223 clinical trial?
NCT06515223 is sponsored by University College, London. The principal investigator is David Baxter, MD at National Health Service, United Kingdom. The trial plans to enroll 20 participants.