BridgeMD
New treatment option for Spinal Cord Injuries
Official title Improving Pelvic Rehabilitation Using Epidural Stimulation After Spinal Cord Injury
ClinicalTrials.gov ID: NCT06515223
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Spinal Cord Injury (supra-sacral)
- AIS A-D
- \>18 years;
- SCI sustained \>12 months ago;
- Neurogenic detrusor overactivity (NDO) confirmed on urodynamics;
You likely can't join if
- Transected cord or SCI related to a neurodegenerative disease
- Any device or metal work in situ that would exclude the patient from having eSCS implanted
- Intra-detrusor botulinum toxin injections within the last 6 months
- Previous surgical intervention on bladder sphincters
- Any diseases and conditions that would exclude the patient from eSCS and/or surgery, for example, degenerative spinal pathology, syrinx and/or tumor.
- Recurrent urinary tract infection refractory to antibiotics
See the full eligibility criteria
- Spinal Cord Injury (supra-sacral)
- AIS A-D
- \>18 years;
- SCI sustained \>12 months ago;
- Neurogenic detrusor overactivity (NDO) confirmed on urodynamics;
- Responsive to dorsal genital nerve stimulation
- Willing and able to provide informed consent
- Stable medical, physical and psychological condition as considered by the investigators
- Able to understand and interact with the study team in English
- Sufficient upper limb function to operate the device
- Suitably optimised bladder and bowel routine
- Transected cord or SCI related to a neurodegenerative disease
- Any device or metal work in situ that would exclude the patient from having eSCS implanted
- Intra-detrusor botulinum toxin injections within the last 6 months
- Previous surgical intervention on bladder sphincters
- Any diseases and conditions that would exclude the patient from eSCS and/or surgery, for example, degenerative spinal pathology, syrinx and/or tumor.
- Recurrent urinary tract infection refractory to antibiotics
- Women who are pregnant or intending to become pregnant (pregnancy test obligatory for woman of childbearing potential) or breast feeding, or lack of safe contraception for women of childbearing capacity.
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders or dementia of the participant
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Enrolment of the investigator, his/her family members, employees, and other dependent persons.
The study team makes the final eligibility decision.
Where it's taking place
- Stanmore, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanmore, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.