Using closed-loop spinal cord stimulation to treat chronic pelvic pain

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

This study is testing a new spinal cord stimulation treatment to see if it can help people with chronic pelvic pain feel better and improve their quality of life.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ainsworth Institute of Pain Management (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT06413277 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of electrically evoked compound action potential (ECAP)-controlled closed-loop spinal cord stimulation (SCS) for treating chronic pelvic pain by targeting the conus medullaris in the spine. The study will assess the efficacy of this approach in alleviating pain and improving quality of life, as well as monitor safety and device performance. Participants will undergo a trial procedure followed by a potential permanent implant, with data collected at various time points over a year. The study will enroll up to 20 subjects with chronic, intractable pelvic pain who meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic intractable pelvic pain that has not responded to conservative treatments for at least six months.

Not a fit: Patients with pelvic pain not related to the specified conditions or those who do not meet the pain severity criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce chronic pelvic pain and improve the quality of life for affected patients.

How similar studies have performed: While this specific approach is novel, similar studies using spinal cord stimulation for chronic pain have shown promising results.

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.

Where this trial is running

New York, New York

• Ainsworth Institute of Pain Management — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Corey W Hunter, MD, FIPP — Ainsworth Institute of Pain Management
• Study coordinator: Zoey Smith

Conditions Chronic Pelvic Pain; Pudendal Neuralgia; Levator Ani Syndrome