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NCT Number: NCT05700318

Study Using the ShiraTronics Migraine Therapy System

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.

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Key information

Conditions

Chronic Migraine, Headache Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Genesis Research Services, Broadmeadow, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

neurostimulator

Device

The ShiraTronics Migraine Therapy System

Primary outcomes

  1. Monthly Headache Days

    Time frame: 12-weeks

    Change in number of mean monthly headache days

Secondary outcomes

  1. 50% reduction in mean Headache days

    Time frame: 12-weeks

    Proportion of subjects with 50% reduction in mean monthly headache days

  2. Monthly Migraine Days

    Time frame: 12-weeks

    Change in mean monthly migraine days

  3. Migraine Disability Assessment Test

    Time frame: 12-weeks

    Change in disability score

  4. Patient-identified Most Bothersome Symptom

    Time frame: 12-weeks

    Change in most bothersome symptom

Study contacts

Contact information is provided by the study sponsor or research team.

Fred Ecklund

CONTACT

[email protected]

1-844-228-7330

Sponsors and collaborators

Lead sponsor

ShiraTronics

Industry

Registry information

Official study title

A Pilot Study Assessing Preliminary Safety and Efficacy of The ShiraTronics Migraine Therapy System in Relieving, Interrupting, and Preventing Chronic Migraine

Acronym: RELIEV-CM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 26, 2023
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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