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Cauda Equina SyndromeBESCESNCT06416878

Brief ES for Recovery of Autonomic Function in CES

A study testing Brief ES at the time of decompression for cauda equina syndrome and Brief ES to facilitate mcturition/removal of catheter in people with Cauda Equina Syndrome, run by University of Liverpool at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cauda Equina Syndrome
What is being tested?
Brief ES at the time of decompression for cauda equina syndrome and Brief ES to facilitate mcturition/removal of catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
15 Feb 2024to 15 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • The Walton Centre NHS Foundation Trust

    Liverpool, Merseyside, L9 7LJ

Other trials in United Kingdom

About this study

Official title: Can Brief Perioperative Epidural Electrical Stimulation Improve Recovery of Autonomic Function in Cauda Equina Syndrome

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

Read the 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).

Being tested
Brief ES at the time of decompression for cauda equina syndrome, Brief ES to facilitate mcturition/removal of catheter
Keywords
cauda equina syndrome, electrical stimulation, spinal cord stimulator, recovery of autonomic function, axonal regeneration
Medical subject headings
Cauda Equina Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief ES at the time of decompression for cauda equina syndromeDevice

    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 catheterDevice

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

Study groups in NCT06416878
Study groupRoleWhat they receive
InterventionExperimentalAll participants
Receives: Device: Brief ES at the time of decompression for cauda equina syndrome; Device: Brief ES to facilitate mcturition/removal of catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate

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

    Measured: 6 months

  2. 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.

    Measured: Post-operatively and at 3 months.

  3. 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.

    Measured: Post-operatively and at 3 months.

  4. 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.

    Measured: At the time of the surgery and immediately post-op

  5. 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.

    Measured: At the time of the surgery and immediately post-op

  6. 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.

    Measured: At the time of the surgery and immediately post-op

Secondary outcomes (6)
  1. Short Form Incontinence Questionnaire (SFIQ)

    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).

    Measured: On admission and at 3, 6 and 12 months.

  2. Arizona Sexual Experiences Scale (ASEX)

    The ASEX consists of 5 questions with answers from 1 (best) to 6 (worst)

    Measured: On admission and at 3, 6 and 12 months.

  3. Neurogenic Bowel Dysfunction (NBD) Questionnaire

    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.

    Measured: On admission and at 3, 6 and 12 months.

  4. Oswestry Disability Index (ODI)

    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).

    Measured: On admission and at 3, 6 and 12 months.

  5. Rand SF-36 Questionnaire

    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).

    Measured: On admission and at 3, 6 and 12 months.

  6. Post-void bladder scan (PVBS)

    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.

    Measured: At baseline, post-operative (x3) and at 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2024
  2. Study start15 Feb 2024
  3. Primary completion8 Sep 2026 (estimated)
  4. Study completion15 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Consecutive patients presenting to neurosurgical department with acute cauda equina syndrome with autonomic dysfunction.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06416878
Sponsor's protocol ID
UoL001787
Acronym
BESCES
Status last verified
Feb 2026
First submitted
8 Jan 2024
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 10729340
  • 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.

    PubMed 19800329
  • 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.

    PubMed 36551285
  • 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.

    PubMed 31432080
  • 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.

    PubMed 25727139
  • 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.

    PubMed 29361981
  • 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.

    PubMed 33558146
  • 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.

    PubMed 34668879
  • 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.

    PubMed 36426378

Questions about this trial

What is this clinical trial studying?

A study testing Brief ES at the time of decompression for cauda equina syndrome and Brief ES to facilitate mcturition/removal of catheter in people with Cauda Equina Syndrome, run by University of Liverpool at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06416878, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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