Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-02-15
2026-09-15
Brief Summary
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The study will assess:
The feasibility of intervention. If brief ES can facilitate conduction in residual neurons. If brief ES can facilitate neuronal recovery
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention
All participants
Brief ES at the time of decompression for cauda equina syndrome
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.
Brief ES to facilitate mcturition/removal of catheter
In patients who do not fully recover function following decompression, brief ES will be applied before second micturition attempt.
Interventions
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Brief ES at the time of decompression for cauda equina syndrome
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.
Brief ES to facilitate mcturition/removal of catheter
In patients who do not fully recover function following decompression, brief ES will be applied before second micturition attempt.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University of Liverpool
OTHER
Responsible Party
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Principal Investigators
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Andrew Marshall, PhD
Role: STUDY_CHAIR
University of Liverpool
Locations
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The Walton Centre NHS Foundation Trust
Liverpool, Merseyside, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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UoL001787
Identifier Type: -
Identifier Source: org_study_id
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