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Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury

RecruitingNAAges 18 Years - anyAllUniversity College, London
NCT06515223 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 t

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📋 Eligibility rules (as published)
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.
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What it tests

  • Epidural Spinal Cord Stimulation
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Where

1 site
Royal National Orthopaedic Hospital
Stanmore, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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