Study of Wireless Nerve Stimulation in the Treatment of Chronic Migraine

Summary

The purpose of this study is to illustrate the safety and effectiveness of the StimRelieve Halo Nerve Stimulator System in the treatment of chronic migraine. The StimRelieve Halo System utilizes a minimally invasive procedure to implant a neurostimulator. This technology includes an octopolar electrode array stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The StimRelieve Halo System eliminates the implantable pulse generator, which has been the most common reason for reoperation or discomfort with existing devices.

For this study, all subjects will be randomized at enrollment into either a delayed or immediate continuation group. The immediate continuation group will immediately continue with the stimulation therapy after the 30-day trial period and will be monitored for a total of 12 months. The delayed activation group will have their device turned off after the 30-day trial period for the next 3-months. At the 3-month visit, both groups be evaluated and the delayed activation group will have their devices reactivated.

All subjects will immediately receive the permanent stimulator(s). The permanent stimulators can easily be removed if non-responders are identified. The wireless technology eliminates the need for externalized extensions, IPG's and thus reoperation. Additionally the outcome is highly dependent on placement of the stimulators. By eliminating the need for a staged trial, infection rates and incidence of pocket pain will decrease.

In this study, subjects will undergo a 30-day trial in order to demonstrate effectiveness. Immediate activation of all devices will be done in the post-op period based on sensory response and subject comfort. Subjects will be seen at 14-days post-implant to assess patient compliance with the device, assess clinical response and to adjust programming parameters if not responding. Subjects will be seen at 1 month post-implant and headache diaries and questionnaires will be reviewed. Subjects not responding to the therapy by at least a 30% reduction in headache days will be deemed non-responders and will be withdrawn from the study and can choose to have the device removed. After the trial period, all responders will follow their random assignment determined at enrollment (delayed or immediate continuation). All subjects will be monitored for a total of 13 months. Adverse events will be monitored throughout the study.

Conditions

• Migraine

Interventions

DEVICE

StimRelieve Halo System

The StimRelieve Halo System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic migraine as defined by the Third edition of the International Classification of headache disorders (ICDH-3). The system provides treatment by delivering small controlled electrical pulses to the occipital and supraorbital nerves, as it has been shown that for chronic migraine headaches the response to combined systems appears to be substantially better than occipital nerves stimulation alone.

Sponsors & Collaborators

• Curonix LLC

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-01

Primary Completion

2025-05-01

Completion

2025-05-01

FDA Device

Yes