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First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine | Clinical Trials | Clareo Health

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First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine

First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine, an Early Feasibility Study

NCT05858801•Salvia BioElectronics

View on ClinicalTrials.gov

Summary

The purpose of this study is to demonstrate the safe use of the PRIMUS system in subjects with chronic migraine. This is a single-center, open label, prospective, early feasibility study to collect initial clinical data on the PRIMUS system for the treatment of chronic migraine.

Eligibility

Age

18 - 84 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Able and willing to provide informed consent
•Age ≥ 18 years and ≤ 84 years at time of consent
•Documented Chronic Migraine, defined as at least eight migraine days/month, for at least 1 year.
•Developed migraine before the age of 50
•Documented failure of 3 or more other preventive therapies (failure meaning ineffective, provoked unacceptable side-effects or contra-indicated) from which at least 1 of the following 2: CGRP mAbs or Onabotulinumtoxin A
•Have at least 1 headache free day per month
•Stable on preventive migraine drugs and alternative treatment for at least three months prior to enrollment.
•Agree to refrain from starting new preventive migraine drugs or other preventive alternative migraine treatments, from 4 weeks before entering the baseline period throughout the duration of the study.
•MRI available (not older than 4 years prior to study enrollment) or willing to undergo an MRI to exclude structural lesions potentially causing headache
•Able and willing to complete a daily headache eDiary

Exclusion Criteria

•Any other chronic primary or secondary headache disorder, unless they can clearly differentiate them from migraine attacks, based on the quality of pain and associated symptoms.
•Concomitant neuromodulation
•Previous failure to an implantable neuromodulation device for neurovascular headache
•Have an existing Active Implantable Medical Device nearby the implant location (e.g. DBS, cochlear implant, …)
•Metal implants in the skull (e.g. skull plates, seeds) nearby the implant.
•Have a pacemaker of implantable cardioverter defibrillator (ICD)
•Current Opioid Use, defined as one or more opioids on more than 4 days/month for 3 consecutive months.
•Use of botulinum toxin injections in the past 3 months.
•Women of childbearing age who are pregnant, nursing or not using contraception

Locations (1)

AZ Delta

Roeselare, Belgium

Key Dates

Start Date

May 9, 2023

Primary Completion Date

December 9, 2023

Completion Date

January 31, 2026

Last Updated

May 16, 2024

Enrollment

ACTUAL participants

Conditions

Chronic Migraine

Interventions

PRIMUS

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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First Evaluation of a Craniofacial Peripheral Nerve Stimulation System in Chronic Migraine

Inclusion Criteria

Exclusion Criteria

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