Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416878
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-01-08
Brief Title:
Brief ES for Recovery of Autonomic Function in CES
Sponsor:
University of Liverpool
Organization:
University of Liverpool
Study Overview
Official Title:
Can Brief Perioperative Epidural Electrical Stimulation Improve Recovery of Autonomic Function in Cauda Equina Syndrome
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BESCES
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 andor 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
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 100000 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 damagedresidual 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
Theoretically there are two possible ways of improving these functions - improving regeneration of damaged cells and improving conduction in partially damagedresidual 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None