Status:
RECRUITING
Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
Lead Sponsor:
University College, London
Collaborating Sponsors:
Royal National Orthopaedic Hospital NHS Trust
Conditions:
Spinal Cord Injuries
Neuromodulation
Eligibility:
All Genders
18+ years
Phase:
NA
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 the...
Detailed Description
Screening: Following confirmation that participants meet the eligibility criteria, they will undergo extensive screening, to confirm their suitability for eSCS implantation. They will meet with multi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06515223
Start Date
October 14 2024
End Date
November 1 2027
Last Update
March 14 2025
Active Locations (1)
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1
Royal National Orthopaedic Hospital
Stanmore, United Kingdom