Brief ES for Recovery of Autonomic Function in CES (NCT06416878) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Brief ES for Recovery of Autonomic Function in CES
United Kingdom40 participantsStarted 2024-02-15
Plain-language summary
BESCES is a study that aims to explore the feasibility of intraoperative brief epidural electrical stimulation (ES) for patients undergoing routine decompression for cauda equina syndrome. In consenting patients, brief ES will be applied using a CE-marked SCS trial kit once sufficient decompression is achieved. In participants who do not recover function following decompression, brief post-op ES will be applied to see if can facilitate micturition and/or removal of the catheter.
The study will assess:
The feasibility of intervention. If brief ES can facilitate conduction in residual neurons. If brief ES can facilitate neuronal recovery
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>18.
* Cauda equina syndrome with bladder, bowel or sexual dysfunction (CES-I or CES-R) secondary to acute lumbar disc prolapse.
* Selected for emergency surgery.
Exclusion Criteria:
* No bladder, bowel or sexual dysfunction (Only bilateral radicular symptoms).
* Previous spinal surgery with risk of adhesions.
* Multilevel degeneration with inadequate safe space to pass epidural electrode.
* Pre-existent bladder, bowel or sexual dysfunction.
* History of peripheral neuropathy.
* Contraindications to neurostimulation (e.g. pacemaker, immune deficiency, uncontrolled diabetes, sepsis, active pressure sore, spinal cord stimulator in situ).
* Intraoperative CSF leak.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying electrical stimulation for cauda equina syndrome and is no longer enrolling new participants — is there any way I could still access this kind of treatment, or are there similar active trials I should look into?
2The trial is measuring pudendal somatosensory evoked potentials, which I understand relate to nerve signals in the pelvic region — what would those test results actually tell us about how my nerves are recovering, and is that kind of testing available to me outside of a trial?
3Since this study is labeled 'Phase NA,' which suggests it may be a very early feasibility or pilot study, what does that mean for how much is actually known about whether this electrical stimulation approach is safe and effective for cauda equina syndrome?
4The trial is testing specific electrical stimulation parameters like frequency, pulse width, and amplitude — are any of these stimulation techniques already used in standard care for cauda equina syndrome, or is this approach still considered experimental?
5Given that I have cauda equina syndrome, what does my doctor think are my best current treatment options, and how does the approach being studied in this trial compare to what's available to me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.