ACTIVE_NOT_RECRUITING

The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain

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Conditions

Cervicogenic HeadacheOccipital NeuralgiaElectrical StimulationNeuromodulationHead painHeadacheNeck pain

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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 purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves at the top of the neck. This study will use a device called the SPRINT® PNS System. PNS stands for peripheral nerve stimulation (PNS). This device is cleared by the FDA for up to 60 days of use for relief of chronic or acute pain.

Official Title

The MONARCH (Multicenter Occipital Neuralgia and Cervicogenic Headache) Case Series Study: Treatment of Head Pain With the SPRINT® Peripheral Nerve Stimulation (PNS) System

Quick Facts

Study Start:2022-10-24
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05491915

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 CriteriaExclusion Criteria
  1. * Diagnosed cervicogenic headache (CGH) or occipital neuralgia (ON)
  1. * Prior cervical or cranial occipital surgery
  2. * Implanted electronic device (dependent on implant's intended treatment, location, and electrical current pathway)
  3. * Pregnant

Contacts and Locations

Study Locations (Sites)

Pacific Research Institute
Santa Rosa, California, 95403
United States
MedVadis Research
Waltham, Massachusetts, 02451
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Center of Clinical Research
Winston-Salem, North Carolina, 27103
United States
Pain Specialists of America - South Austin - James Casey
Austin, Texas, 78745
United States
Pain Specialists of America - Cedar Park
Cedar Park, Texas, 78613
United States
Institute of Precision Pain Medicine
Corpus Christi, Texas, 78414
United States
Pain Specialists of America - Round Rock
Round Rock, Texas, 78681
United States
Pain Specialists of America - San Marcos
San Marcos, Texas, 78666
United States
University of Utah
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: SPR Therapeutics, Inc.

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 Date2022-10-24
Study Completion Date2027-08

Study Record Updates

Study Start Date2022-10-24
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • Electrical Stimulation
  • Neuromodulation
  • Head pain
  • Headache
  • Neck pain

Additional Relevant MeSH Terms

  • Cervicogenic Headache
  • Occipital Neuralgia