Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515223
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ImPRESS
Brief Summary:
The investigators will recruit up to 20 volunteers with chronic supra-sacral SCI Following screening eligible participants will enter Phase I they will complete baseline outcome measures and then have the epidural spinal cord stimulator eSCS implanted with either percutaneous or paddle electrodes Preoperative and intraoperative testing will determine exact location of electrodes
Mapping and optimisation of stimulation parameters will be performed simultaneously with urodynamic investigations of bladder function and anorectal physiology investigations of bowel function The acute effects of eSCS to suppress bladder overactivity facilitate voiding prevent unwanted reflex sphincter activity and pelvic floor function will guide development of eSCS programmes for use at home
In Phase II participants will use eSCS at home for 12-weeks Participants will also be taught how to perform bladder and pelvic floor muscle training PFMT in combination with eSCS
Outcome measures assessing bladder bowel sexual function quality of life motor function and spasticity will be captured prior to and following the 12-week intervention and at 3 and 6 month follow up
Mapping and optimisation of stimulation parameters will be performed simultaneously with urodynamic investigations of bladder function and anorectal physiology investigations of bowel function The acute effects of eSCS to suppress bladder overactivity facilitate voiding prevent unwanted reflex sphincter activity and pelvic floor function will guide development of eSCS programmes for use at home
In Phase II participants will use eSCS at home for 12-weeks Participants will also be taught how to perform bladder and pelvic floor muscle training PFMT in combination with eSCS
Outcome measures assessing bladder bowel sexual function quality of life motor function and spasticity will be captured prior to and following the 12-week intervention and at 3 and 6 month follow up
Detailed Description:
Screening
Following confirmation that participants meet the eligibility criteria they will undergo extensive screening to confirm their suitability for eSCS implantation They will meet with multidisciplinary team members to ensure they are fully educated about the potential risks and to manage their expectations of outcomes They will undergo a urodynamics assessment following standard protocol If they have neurogenic detrusor overactivity NDO and are responsive to dorsal genital nerve stimulation to supress NDO they will progress to have an MRI
Phase I
Baseline measurements will be completed as outlined in outcome measures Participants will undergo implantation of a Senza implantable pulse generator Nevro Corp CA USA which is MRI-conditional and multi-programmable with Surpass Surgical or Percutaneous leads Nevro Corp CA USA The device will be implanted under the skin either at the abdomen superior to iliac crest or buttocks
Participants will attend three mapping sessions to determine effective stimulation sites and parameters for the lower limbs bladder bowel and pelvic floor muscles An optional cardiovascular mapping session will also be offered The mapping sessions will generate several eSCS programmes for participants to use at home which target specific effects supression of NDO facilitation of voiding bowel management and pelvic floor muscle activation
Participants will have a pelvic floor examination and be taught a pelvic floor muscle training programme to complete at home They will be educated on how to use the above programmes as part of their daily routine
Phase II
For the following 12-weeks participants will use their eSCS programmes and complete daily PFMT At week 3 6 and 9 they will be invited to attend a face to face pelvic floor clinic to review their programme and progress their exercises as indicated Participants will be called once a week by a member of the research team to check how the participant is managing with their deviceprogrammes identify any issues and have any questions answered They will be asked to complete a 3-day bladder diary and up to 14-day bowel diary during this period
Participants will repeat baseline measures with urodynamics anorectal physiology and global perception of improvement measure at the end of the 12-week home trial
Participants will be offered for their eSCS device to be explanted or they can continue with this in situ They will have time to consider this and discuss this with the clinical care team and researchers Irrespective of decision with participants consent the investigators will continue to follow them up 3 and 6 months later
If participants keep the SCS device following the 12-week home trial the repeat bladder and bowel diary assessments will be captured during a period of 2-weeks without stimulation They will then be able to proceed with using this device as normal
All participants will be invited to take part in an interview to discuss their participation in the trial and their decision to either keep or remove the SCS device This will be audio recorded which will be destroyed once transformed into a written script
Participants will return to RNOH Stanmore to complete re-assessment of outcomes at 3 and 6 months
At the end of the study participants will be offered for their eSCS device to be explanted or they can continue with this in situ with ongoing support from The London Spinal Cord Injury Centre teamservice
Following confirmation that participants meet the eligibility criteria they will undergo extensive screening to confirm their suitability for eSCS implantation They will meet with multidisciplinary team members to ensure they are fully educated about the potential risks and to manage their expectations of outcomes They will undergo a urodynamics assessment following standard protocol If they have neurogenic detrusor overactivity NDO and are responsive to dorsal genital nerve stimulation to supress NDO they will progress to have an MRI
Phase I
Baseline measurements will be completed as outlined in outcome measures Participants will undergo implantation of a Senza implantable pulse generator Nevro Corp CA USA which is MRI-conditional and multi-programmable with Surpass Surgical or Percutaneous leads Nevro Corp CA USA The device will be implanted under the skin either at the abdomen superior to iliac crest or buttocks
Participants will attend three mapping sessions to determine effective stimulation sites and parameters for the lower limbs bladder bowel and pelvic floor muscles An optional cardiovascular mapping session will also be offered The mapping sessions will generate several eSCS programmes for participants to use at home which target specific effects supression of NDO facilitation of voiding bowel management and pelvic floor muscle activation
Participants will have a pelvic floor examination and be taught a pelvic floor muscle training programme to complete at home They will be educated on how to use the above programmes as part of their daily routine
Phase II
For the following 12-weeks participants will use their eSCS programmes and complete daily PFMT At week 3 6 and 9 they will be invited to attend a face to face pelvic floor clinic to review their programme and progress their exercises as indicated Participants will be called once a week by a member of the research team to check how the participant is managing with their deviceprogrammes identify any issues and have any questions answered They will be asked to complete a 3-day bladder diary and up to 14-day bowel diary during this period
Participants will repeat baseline measures with urodynamics anorectal physiology and global perception of improvement measure at the end of the 12-week home trial
Participants will be offered for their eSCS device to be explanted or they can continue with this in situ They will have time to consider this and discuss this with the clinical care team and researchers Irrespective of decision with participants consent the investigators will continue to follow them up 3 and 6 months later
If participants keep the SCS device following the 12-week home trial the repeat bladder and bowel diary assessments will be captured during a period of 2-weeks without stimulation They will then be able to proceed with using this device as normal
All participants will be invited to take part in an interview to discuss their participation in the trial and their decision to either keep or remove the SCS device This will be audio recorded which will be destroyed once transformed into a written script
Participants will return to RNOH Stanmore to complete re-assessment of outcomes at 3 and 6 months
At the end of the study participants will be offered for their eSCS device to be explanted or they can continue with this in situ with ongoing support from The London Spinal Cord Injury Centre teamservice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None