Status:
WITHDRAWN
Study of Wireless Nerve Stimulation in the Treatment of Chronic Migraine
Lead Sponsor:
Curonix LLC
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 min...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02725554
Start Date
May 1 2025
End Date
May 1 2025
Last Update
May 8 2025
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