Brief ES for Recovery of Autonomic Function in CES
- Conditions
- Cauda Equina Syndrome
- Interventions
- Device: Brief ES at the time of decompression for cauda equina syndromeDevice: Brief ES to facilitate mcturition/removal of catheter
- Registration Number
- NCT06416878
- Lead Sponsor
- University of Liverpool
- Brief 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
- Detailed Description
Cauda equina syndrome (CES), defined as a compression of nerves controlling bowel, bladder and sexual function due to lumbar disc prolapse has a prevalence of 2 per 100,000 UK population per year. It mostly affects individuals 30-49 years of age. Emergency surgery to decompress the nerves is the mainstay of treatment. Despite adequate decompression, 17% of patients are left incontinent and 50% experience persistent bowel, bladder or sexual dysfunction needing long-term supportive symptomatic management and compromising their social cohesion and economic productivity.
Theoretically, there are two possible ways of improving these functions - improving regeneration of damaged cells and improving conduction in partially damaged/residual cells. The use of perioperative electrical stimulation (ES) has shown significant promise in facilitating recovery in peripheral nerve compression syndromes. Epidural stimulation is routinely used for treating neuropathic pain and there is anecdotal evidence of improved bladder and bowel function in patients with CES who have received epidural spinal cord stimulation for chronic pain.
The overall aim of this feasibility study is to determine if a full definitive RCT is possible. The investigators want to see if it is possible to timely and safely deliver epidural stimulation in patients presenting with bowel, bladder or sexual dysfunction due to cauda equina compression, undergoing emergency lumbar decompression, assess the potential effect size of brief post-decompression ES proximal to the level of compression in facilitating axonal regeneration to support further RCT. The investigators also want to see if brief ES can improve conduction in residual neurons.
40 patients presenting with CES shall be enrolled. At the time of decompression surgery, consenting patients shall receive ES. With standard care, patients who still have symptoms after decompression, remain symptomatic at 1 year. Comparison of functional outcomes post-surgery and at 3, 6 and 12 months will enable assessment of recovery due to axonal regeneration.
Results shall assess the safety and feasibility of doing the study in emergency settings - enrolment and consent issues and assess effect size, this will provide sufficient information and, if successful, will lead to a definitive Randomised Control Trial (RCT).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Brief ES to facilitate mcturition/removal of catheter All participants Intervention Brief ES at the time of decompression for cauda equina syndrome All participants
- Primary Outcome Measures
Name Time Method Recruitment Rate 6 months Recruitment rate of 50% or above will be considered sufficient for feasibility of conducting future RCT.
Pudendal Somatosensory Evoked Potentials (SEP) - amplitude (uV) Post-operatively and at 3 months. In participants who do not recover autonomic function, Pudendal Nerve SEP will be performed to assess baseline conduction in residual neurons and recovery rate. Results at 3 months will be compared against baseline.
Stimulation parameters - Frequency (Hz) At the time of the surgery and immediately post-op Intraoperative stimulation parameters will be set to the motor threshold - visually assessed motor response to stimulation. Post-operative stimulation parameters will be set according to patients response - sensation of motor contraction or paraesthesia. Default frequency is 20 Hz and can be modified in 10Hz increments. Descriptive analysis of these parameters shall enable optimisation of settings in future studies.
Stimulation parameters - Amplitude (mA) At the time of the surgery and immediately post-op Intraoperative stimulation parameters will be set to the motor threshold - visually assessed motor response to stimulation. Post-operative stimulation parameters will be set according to patients response - sensation of motor contraction or paraesthesia. Amplitude is increased in 0.1mA increments until response is ascertained. Maximal safe amplitude is considered to be 15mA. Descriptive analysis of these parameters shall enable optimisation of settings in future studies.
Pudendal Somatosensory Evoked Potentials (SEP) - latency (ms) Post-operatively and at 3 months. In participants who do not recover autonomic function, Pudendal Nerve SEP will be performed to assess baseline conduction in residual neurons and recovery rate. Results at 3 months will be compared against baseline.
Stimulation parameters - Pulse width (microseconds) At the time of the surgery and immediately post-op Intraoperative stimulation parameters will be set to the motor threshold - visually assessed motor response to stimulation. Post-operative stimulation parameters will be set according to patients response - sensation of motor contraction or paraesthesia. Default pulse width is 100 microseconds and it can be adjusted in 10 microsecond increments. Descriptive analysis of these parameters shall enable optimisation of settings in future studies.
- Secondary Outcome Measures
Name Time Method Arizona Sexual Experiences Scale (ASEX) On admission and at 3, 6 and 12 months. The ASEX consists of 5 questions with answers from 1 (best) to 6 (worst)
Short Form Incontinence Questionnaire (SFIQ) On admission and at 3, 6 and 12 months. The SFIQ consists of 5 items. Items 1 and 5 are Yes/No questions. Item 2 is an 8-question scale with answers ranging from 0 (best) to 3 (worst) each. Item 3 is a scale ranging from 1 (best) to 8 (worst). Item 4 is a scale ranging from 1 (best) to 6 (worst).
Neurogenic Bowel Dysfunction (NBD) Questionnaire On admission and at 3, 6 and 12 months. NBD is a 10-question item with a score range from 0 (best) to 47 (worst). A score of 0-6 is considered very minor, 7-9 minor, 10-13 moderate and 14+ severe.
Oswestry Disability Index (ODI) On admission and at 3, 6 and 12 months. The ODI assesses disability related to back pain. It is a 10-question item, each scored from 0 (best) to 5 (worst). The total score is between 0 (best) and 50 (worst).
Rand SF-36 Questionnaire On admission and at 3, 6 and 12 months. Rand Short Form Health Survey (SF-36) is a 36-question tool, developed at RAND as part of the Medical Outcomes Study. It assesses the quality of life in 9 categories (Physical functioning, Role limitations due to physical health, Role limitations due to emotional problems, Energy/fatigue, Emotional well-being, Social functioning, Pain, General health, Health change). Each category is scored from 0% (worst) to 100% (best).
Post-void bladder scan (PVBS) At baseline, post-operative (x3) and at 3 months. PVBS assesses post-micturition bladder volume. Volume above 200mL suggests incomplete bladder emptying or retention. Trends in PVBS will be assessed post-operatively and at 3-month follow-up in patients with incomplete recovery following the surgery.
Trial Locations
- Locations (1)
The Walton Centre NHS Foundation Trust
🇬🇧Liverpool, Merseyside, United Kingdom