Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial

Launched by AINSWORTH INSTITUTE OF PAIN MANAGEMENT · May 10, 2024

Keywords

ClinConnect Summary

The HOPE Trial is a clinical study designed to explore a new treatment for chronic pelvic pain, which can be a challenging condition to manage. This trial focuses on using a method called ECAP-controlled closed-loop spinal cord stimulation (SCS) to target a specific area of the spine known as the conus medullaris. The aim is to see if this treatment can effectively reduce pain for individuals suffering from chronic pelvic pain, including conditions like pudendal neuralgia, which is pain in the pelvic area often related to injury or surgery.

To be eligible for the trial, participants need to be at least 18 years old and have been experiencing significant pelvic pain for at least six months, which has not improved with standard treatments. They must also have a specific level of pain intensity, as measured on a scale. Participants in the trial can expect to undergo a surgical procedure to receive the spinal cord stimulation device and will be closely monitored throughout the study. It's important to note that certain individuals, such as those with specific medical histories or existing pain treatments, may not qualify for participation. This trial is currently recruiting participants who are willing to contribute to this important research on managing chronic pelvic pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is 18 years of age or older at the time of enrollment.
• • 2. Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm pain) at baseline.
• • 3. 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.
• • 4. Subject has pain resulting from a known injury (surgery or trauma).
• • 5. 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.
• • 6. Subject is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.
• • 7. Subject is willing and capable of giving informed consent.
• • 8. Subject is willing and able to comply with study-related requirements, procedures, and visits.
• Exclusion Criteria:
• • 1. Subject is pregnant or nursing.
• • 2. Subject is involved in a malignancy or injury claim under current litigation or has pending/approved worker's compensation claim.
• • 3. Subject's mechanism of pain is unknown.
• • 4. Suspected cause and onset of pain are more than 30 days apart.
• • 5. Subject has history of small fiber neuropathy, mitochondrial disease, fibromyalgia, addiction, CRPS in secondary pain area, and/or atypical facial pain.
• • 6. Subject has been diagnosed with Crohn's Disease, Irritable Bowel Syndrome, ulcerous colitis, or any other inflammatory disease that is ongoing.
• • 7. 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.
• • 8. Subject has a history of sexual abuse and/or sexual trauma.
• • 9. Subject has a history of unmanaged depression or anxiety that pre-dates the onset of symptoms.
• • 10. Subject is using greater than 100 MME (morphine milligram equivalents) of opioids at baseline.
• • 11. Subject shows evidence of an active, disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
• • 12. Subject has previous neuromodulation experience including SCS (Spinal Cord Stimulator) and/or DRG (Dorsal Root Ganglion).
• • 13. Subject has an existing drug pump and/or SCS system, or another active implantable device such as a pacemaker, deep brain stimulator, or sacral nerve stimulator.
• • 14. Subject is concomitantly participating in another clinical study.