Study of Wireless Nerve Stimulation in the Treatment of Chronic Migraine

Prospective, Randomized, Controlled, Multi-Center Study of Wireless Nerve Stimulation in the Treatment of Chronic Migraine

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not responding to the therapy by at least a 30% reduction in headache days will be deemed non-responders and will be withdrawn from the study and can choose to have the device removed.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.

Inclusion Criteria:

• Subject is ≥ 18 years but less than 65 years of age at time of informed consent;
• Subject who developed chronic migraine before the age of 60 years old;
• Subjects have been diagnosed with chronic migraine according to the International Classification of Headache Disorders-3 (ICHD-3) (2013) criteria;
• No medication overuse and not attributed to another causative disorder;
• Subjects have chronic migraine for at least 6 months prior to enrollment;
• Are refractory to conventional pharmacological chronic migraine treatments as defined by the failure to respond, or the intolerance, to at least 3 prophylaxis therapies (of which one is topiramate if not contraindicated) as determined by the investigator;
• Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
• Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
• Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, and electronic diary equipment, and has the ability to undergo study assessments and provide accurate responses;
• Based on the opinion of the implanter, subject is a good surgical candidate for the implant procedure;
• Subject is male or non-pregnant female. If female of child-bearing potential, must have a negative pregnancy test at baseline visit, and if sexually active, must be using a medically acceptable method of contraception for the duration of their study participation; Subject is deemed to be neuropsychosocially appropriate for implantation therapies based of the assessment of a Clinical Psychologist, using face-to-face encounters and the psychological testing described in the measures.

Exclusion Criteria:

• Subject has undergone botulinum toxin (BOTOX) injections of the head and/or neck in the last 3 months;
• Subject is on prescribed opioid medication;
• Subject has a history of trigeminal autonomic cephalalgias;
• Subject has a history of other primary or secondary headache disorders;
• Subject has a history of trigeminal neuralgia;
• Subject has cranial postherpetic neuralgia (shingles);
• Subject has an active systemic infection or is immunocompromised; Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication;
• Bleeding complications or coagulopathy issues;
• A life expectancy of less than one year;
• Any active implanted device whether turned off or on;
• Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.
• Based on the medical opinion of the Principal Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
• Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
• Subject is currently involved in litigation regarding injury, or is receiving worker's compensation benefits;
• Subject is currently being treated with repetitive transcranial magnetic stimulation r(TMS) or electro convulsion therapy (ECT).