RECRUITING

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

Conditions

Chronic Pelvic Pain Pudendal Neuralgia Levator Ani Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-02-05

Study Completion:2027-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06413277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Zoey Smith

CONTACT

(212) 203 2813

zsmith@ainpain.com

Principal Investigator

Corey W Hunter, MD, FIPP

PRINCIPAL_INVESTIGATOR

Ainsworth Institute of Pain Management

Study Locations (Sites)

Ainsworth Institute of Pain Management

New York, New York, 10022

United States

Collaborators and Investigators

Sponsor: Ainsworth Institute of Pain Management

Corey W Hunter, MD, FIPP, PRINCIPAL_INVESTIGATOR, Ainsworth Institute of Pain Management

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-05

Study Completion Date2027-01-01

Study Record Updates

Study Start Date2024-02-05

Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

Chronic Pelvic Pain
Pudendal Neuralgia
Levator Ani Syndrome

Additional Relevant MeSH Terms

Chronic Pelvic Pain
Pudendal Neuralgia