Study Using the ShiraTronics Migraine Therapy System (RELIEV-CM)

ShiraTronics

Status: Enrolling

Conditions: Chronic Migraine, Headache

Treatments: Device: neurostimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT05700318

STCM01

Details and patient eligibility

About

The purpose of this pilot study is to assess the preliminary safety and efficacy of the ShiraTronics Migraine Therapy System in prophylactic treatment of patients with refractory chronic migraine.

Enrollment: 40 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants who are 22 years of age or older.
2. History of migraine ≥ 12 months.
3. Participants experiencing between 15 to 26 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation.
4. Inadequate response to, unwilling, or contraindicated to Onabotulinumtoxin A and CGRP monoclonal antibodies therapy.
5. Stable use of migraine medication.

Exclusion criteria

1. Post-traumatic headache.
2. Medication overuse headache.
3. New daily persistent headache.
4. Report experiencing unremitting, continuous headaches with no relief.
5. Previously implanted neurostimulator to treat headache.
6. History of cervical radiofrequency ablation or had any other intervention/device for migraine.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Neurostimulation

Experimental group

Description:

Neurostimulation will be delivered to target nerves.

Treatment:

Device: neurostimulator