Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelv… (NCT06413277) | Clinical Trial Compass
RecruitingNot Applicable
Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial
United States20 participantsStarted 2024-02-05
Plain-language summary
The aim of the study is to evaluate the effectiveness of using ECAP (electrically evoked compound action potential)-controlled CL (closed-loop) SCS (spinal cord stimulation) to treat chronic pelvic pain by stimulating an area in the spine called the conus medullaris (the lowermost tapering extremity of the spinal cord).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is 18 years of age or older at the time of enrollment.
. Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm pain) at baseline.
. Subject has been diagnosed with chronic intractable pain of the trunk and/or limbs specifically related to pelvic/genital/perineal/anorectal pain, which has been refractory to conservative therapy for a minimum of 6 months.
. Subject has pain resulting from a known injury (surgery or trauma).
. Subject has been clinically diagnosed with chronic pelvic pain (pain that occurs in the region of the pelvis), including diagnoses such as, but not limited to, complex regional pain syndrome (CRPS types 1 and 2), postsurgical pain, post-traumatic injury pain, interstitial cystitis/painful bladder syndrome, post-hysterectomy pain, post-prostatectomy pain, vulvodynia, chronic ovarian pain, and pudendal neuralgia of a known cause.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy: Proportion of patients achieving at least 50% and 80% relief from pelvic pain and pelvic pain-related negative impact to quality of life compared to baseline
. Subject is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
. Subject is willing and capable of giving informed consent.
. Subject is willing and able to comply with study-related requirements, procedures, and visits.
Exclusion criteria
. Subject is pregnant or nursing.
. Subject is involved in a malignancy or injury claim under current litigation or has pending/approved worker's compensation claim.
. Subject's mechanism of pain is unknown.
. Suspected cause and onset of pain are more than 30 days apart.
. Subject has history of small fiber neuropathy, mitochondrial disease, fibromyalgia, addiction, CRPS in secondary pain area, and/or atypical facial pain.
. Subject has been diagnosed with Crohn's Disease, Irritable Bowel Syndrome, ulcerous colitis, or any other inflammatory disease that is ongoing.
. Subject has a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.
. Subject has a history of sexual abuse and/or sexual trauma.