Using electrical stimulation to improve recovery in cauda equina syndrome
Can Brief Perioperative Epidural Electrical Stimulation Improve Recovery of Autonomic Function in Cauda Equina Syndrome
This study is testing if using electrical stimulation during surgery can help people with cauda equina syndrome recover better and regain functions like bladder control.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Liverpool Academic / other |
| Locations | 1 site (Liverpool, Merseyside) |
| Trial ID | NCT06416878 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of using brief epidural electrical stimulation (ES) during routine decompression surgery for patients with cauda equina syndrome (CES). The intervention aims to assess whether ES can enhance neuronal recovery and improve functions such as micturition in patients who do not regain function post-surgery. The study will evaluate the safety and effectiveness of delivering ES in a timely manner during the surgical procedure. If successful, this could pave the way for a larger definitive randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with cauda equina syndrome experiencing bladder, bowel, or sexual dysfunction due to acute lumbar disc prolapse.
Not a fit: Patients without bladder, bowel, or sexual dysfunction, or those with contraindications to neurostimulation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery of bowel, bladder, and sexual functions in patients with cauda equina syndrome.
How similar studies have performed: While the use of epidural stimulation has shown promise in other contexts, this specific approach for cauda equina syndrome is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Liverpool, Merseyside
- The Walton Centre NHS Foundation Trust — Liverpool, Merseyside, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Rafal A Szylak, MBBS eq.
- Email: Rafal.Szylak@nhs.net
- Phone: 0151 525 3611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.