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 range18 Years
SexALL
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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.
✓. 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.
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
✕. 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.