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

NCT06413277 | Recruiting FDA Device

• 1 other identifier: 1351927
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Chronic Pelvic Pain; Pudendal Neuralgia

Keywords

Chronic Pelvic Pain; Pudendal Neuralgia; Levator Ani Syndrome

Outcome Measures

Primary Outcomes (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

  Pelvic Pain Reduction will be evaluated using the Visual Analog Scale (VAS) by comparing baseline VAS Scores to 3-, 6-, and 12- month post ECAP CL-SCS Implant VAS Scores.

  12 months

Secondary Outcomes (10)

• Impact of pain on activities of daily living: Proportion of patients achieving at least 50% and 80% reduction in impact of pain on activities of daily living compared to baseline.

  12 months

• Changes in Pain quality: Proportion of patients achieving at least 50% and 80% relief in regard to pain quality compared to baseline

  12 months

• Changes in Health-Related Quality of life: Proportion of patients achieving at least 50% and 80% improvement in health-related quality of life compared to baseline.

  12 months

• Changes in sleep quality: Proportion of patients achieving at least 50% and 80% improvement in sleep quality compared to baseline.

  12 months

• Changes in Anxiety and Depression: Proportion of patients achieving at least 50% and 80% reduction in anxiety and depression compared to baseline.

  12 months

Interventions

Saluda Evoke Smart SCS System DEVICE

Surgical implantation of the Saluda Evoke Smart SCS System targeting the conus medullaris for stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 or older with chronic, intractable pelvic pain

You may qualify if:

• 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.

You may not qualify if:

• 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, 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.
• Subject has a history of unmanaged depression or anxiety that pre-dates the onset of symptoms.
• Subject is using greater than 100 MME (morphine milligram equivalents) of opioids at baseline.
• 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.
• Subject has previous neuromodulation experience including SCS (Spinal Cord Stimulator) and/or DRG (Dorsal Root Ganglion).
• 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.
• Subject is concomitantly participating in another clinical study.

Sponsors & Collaborators

• Ainsworth Institute of Pain Management: lead
• Saluda Medical Pty Ltd: collaborator

Study Sites (1)

Ainsworth Institute of Pain Management

New York, New York, 10022, United States

RECRUITING

Related Publications (42)

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MeSH Terms

Conditions

Pudendal Neuralgia; Levator syndrome

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Corey W Hunter, MD, FIPP

  Ainsworth Institute of Pain Management

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoey Smith

CONTACT

(212) 203 2813; zsmith@ainpain.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: May 14, 2024
• Study Start: February 5, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)