Brief ES for Recovery of Autonomic Function in CES

NCT06416878 | Active Not Recruiting

• 1 other identifier: UoL001787
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Cauda Equina Syndrome

Keywords

cauda equina syndrome; electrical stimulation; spinal cord stimulator; recovery of autonomic function; axonal regeneration

Outcome Measures

Primary Outcomes (6)

• Recruitment Rate

  Recruitment rate of 50% or above will be considered sufficient for feasibility of conducting future RCT.

  6 months

• Pudendal Somatosensory Evoked Potentials (SEP) - amplitude (uV)

  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.

  Post-operatively and at 3 months.

• Pudendal Somatosensory Evoked Potentials (SEP) - latency (ms)

  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.

  Post-operatively and at 3 months.

• Stimulation parameters - Frequency (Hz)

  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.

  At the time of the surgery and immediately post-op

• Stimulation parameters - Amplitude (mA)

  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.

  At the time of the surgery and immediately post-op

• Stimulation parameters - Pulse width (microseconds)

  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.

  At the time of the surgery and immediately post-op

Secondary Outcomes (6)

• Short Form Incontinence Questionnaire (SFIQ)

  On admission and at 3, 6 and 12 months.

• Arizona Sexual Experiences Scale (ASEX)

  On admission and at 3, 6 and 12 months.

• Neurogenic Bowel Dysfunction (NBD) Questionnaire

  On admission and at 3, 6 and 12 months.

• Oswestry Disability Index (ODI)

  On admission and at 3, 6 and 12 months.

• Rand SF-36 Questionnaire

  On admission and at 3, 6 and 12 months.

Study Arms (1)

Intervention

EXPERIMENTAL

All participants

Device: Brief ES at the time of decompression for cauda equina syndrome; Device: Brief ES to facilitate mcturition/removal of catheter

Interventions

Brief ES to facilitate mcturition/removal of catheter DEVICE

In patients who do not fully recover function following decompression, brief ES will be applied before second micturition attempt.

Intervention

Brief ES at the time of decompression for cauda equina syndrome DEVICE

In patients operated for acute cauda equina syndrome with autonomic dysfunction epidural ES will be delivered utilising SCS trial electrode. It will be delivered for 10 minutes caudal to compression site and for 60 mins cranial to compression site while the wound is closed and patient recovered.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liverpool: lead

Study Sites (1)

The Walton Centre NHS Foundation Trust

Liverpool, Merseyside, L9 7LJ, United Kingdom

Location

Related Publications (9)

• Al-Majed AA, Neumann CM, Brushart TM, Gordon T. Brief electrical stimulation promotes the speed and accuracy of motor axonal regeneration. J Neurosci. 2000 Apr 1;20(7):2602-8. doi: 10.1523/JNEUROSCI.20-07-02602.2000.

  PMID: 10729340 BACKGROUND

• Gordon T, Amirjani N, Edwards DC, Chan KM. Brief post-surgical electrical stimulation accelerates axon regeneration and muscle reinnervation without affecting the functional measures in carpal tunnel syndrome patients. Exp Neurol. 2010 May;223(1):192-202. doi: 10.1016/j.expneurol.2009.09.020. Epub 2009 Oct 1.

  PMID: 19800329 BACKGROUND

• Juckett L, Saffari TM, Ormseth B, Senger JL, Moore AM. The Effect of Electrical Stimulation on Nerve Regeneration Following Peripheral Nerve Injury. Biomolecules. 2022 Dec 12;12(12):1856. doi: 10.3390/biom12121856.

  PMID: 36551285 BACKGROUND

• Power HA, Morhart MJ, Olson JL, Chan KM. Postsurgical Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial. Neurosurgery. 2020 Jun 1;86(6):769-777. doi: 10.1093/neuros/nyz322.

  PMID: 31432080 BACKGROUND

• Wong JN, Olson JL, Morhart MJ, Chan KM. Electrical stimulation enhances sensory recovery: a randomized controlled trial. Ann Neurol. 2015 Jun;77(6):996-1006. doi: 10.1002/ana.24397. Epub 2015 May 4.

  PMID: 25727139 BACKGROUND

• Barber B, Seikaly H, Ming Chan K, Beaudry R, Rychlik S, Olson J, Curran M, Dziegielewski P, Biron V, Harris J, McNeely M, O'Connell D. Intraoperative Brief Electrical Stimulation of the Spinal Accessory Nerve (BEST SPIN) for prevention of shoulder dysfunction after oncologic neck dissection: a double-blinded, randomized controlled trial. J Otolaryngol Head Neck Surg. 2018 Jan 23;47(1):7. doi: 10.1186/s40463-017-0244-9.

  PMID: 29361981 BACKGROUND

• Rascon-Ramirez FJ. Spinal cord stimulation and cauda equina syndrome: Could it be a valid option? A report of two cases. Neurocirugia (Engl Ed). 2021 Feb 5:S1130-1473(21)00003-8. doi: 10.1016/j.neucir.2020.12.002. Online ahead of print. English, Spanish.

  PMID: 33558146 BACKGROUND

• Sayanagi J, Acevedo-Cintron JA, Pan D, Schellhardt L, Hunter DA, Snyder-Warwick AK, Mackinnon SE, Wood MD. Brief Electrical Stimulation Accelerates Axon Regeneration and Promotes Recovery Following Nerve Transection and Repair in Mice. J Bone Joint Surg Am. 2021 Oct 20;103(20):e80. doi: 10.2106/JBJS.20.01965.

  PMID: 34668879 BACKGROUND

• Woodfield J, Hoeritzauer I, Jamjoom AAB, Jung J, Lammy S, Pronin S, Hannan CJ, Watts A, Hughes L, Moon RDC, Darwish S, Roy H, Copley PC, Poon MTC, Thorpe P, Srikandarajah N, Grahovac G, Demetriades AK, Eames N, Sell PJ, Statham PFX; UCES Collaborators; British Neurosurgical Trainee Research Collaborative. Presentation, management, and outcomes of cauda equina syndrome up to one year after surgery, using clinician and participant reporting: A multi-centre prospective cohort study. Lancet Reg Health Eur. 2022 Nov 17;24:100545. doi: 10.1016/j.lanepe.2022.100545. eCollection 2023 Jan.

  PMID: 36426378 BACKGROUND

MeSH Terms

Conditions

Cauda Equina Syndrome

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Polyradiculoneuropathy; Polyneuropathies

Study Officials

• Andrew Marshall, PhD

  University of Liverpool

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Consecutive patients presenting to neurosurgical department with acute cauda equina syndrome with autonomic dysfunction.

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: May 16, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)