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

NCT05858801 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-04-23

No results posted yet for this study

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.

Conditions

  • Chronic Migraine

Interventions

DEVICE

PRIMUS

PRIMUS system

Sponsors & Collaborators

  • Salvia BioElectronics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-09
Primary Completion
2023-12-09
Completion
2026-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05858801 on ClinicalTrials.gov