Actively Recruiting
Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial
Led by Ainsworth Institute of Pain Management · Updated on 2024-05-14
20
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
Sponsors
A
Ainsworth Institute of Pain Management
Lead Sponsor
S
Saluda Medical Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 at baseline.
- Subject has chronic intractable pelvic/genital/perineal/anorectal pain lasting at least 6 months and refractory to conservative therapy.
- Subject's pain is due to a known injury such as surgery or trauma.
- Subject is clinically diagnosed with chronic pelvic pain, including conditions like complex regional pain syndrome, postsurgical pain, post-traumatic injury pain, interstitial cystitis, post-hysterectomy pain, post-prostatectomy pain, vulvodynia, chronic ovarian pain, or pudendal neuralgia.
- Subject is an appropriate candidate for surgical procedures as judged by 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.
You will not qualify if you...
- 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, complex regional pain syndrome in secondary pain area, or atypical facial pain.
- Subject has Crohn's Disease, Irritable Bowel Syndrome, ulcerous colitis, or any ongoing inflammatory disease.
- Subject has medical conditions or pain in other areas not intended for treatment with spinal cord stimulation that could interfere with study procedures.
- Subject has history of sexual abuse and/or sexual trauma.
- Subject has unmanaged depression or anxiety that started before symptom onset.
- Subject uses more than 100 morphine milligram equivalents (MME) of opioids at baseline.
- Subject has active psychological or psychiatric disorders affecting pain perception, intervention compliance, or outcome evaluation.
- Subject has previous neuromodulation experience including spinal cord stimulator or dorsal root ganglion stimulator.
- Subject has an existing drug pump, spinal cord stimulator, pacemaker, deep brain stimulator, or sacral nerve stimulator implanted.
- Subject is currently participating in another clinical study.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ainsworth Institute of Pain Management
New York, New York, United States, 10022
Actively Recruiting
Research Team
Z
Zoey Smith
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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