Study of Gammacore Sapphire for the Acute and Preventive Treatment of Post-Traumatic Headache (GAP-PTH)

Study Overview
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Brief Summary
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The purpose of this single-center, prospective, randomized, double-blind, sham controlled, parallel-group study is to collect clinical data related to the safety and efficacy of vagus nerve stimulation for the acute and preventive treatment of Post Traumatic Headache.

Detailed Description
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The study will enroll 60 subjects over a period of 14 weeks each. Subjects will use either a sham or active device to treat acute Post Traumatic Headache. Investigators will collect clinical data related to the use of the device.

Official Title
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A Randomized, Single-Center, Double-Blind, Parallel, Sham-Controlled Study of Gammacore Sapphire (Non-Invasive Vagus Nerve Stimulator) for the Acute and Preventive Treatment of Post-Traumatic Headache (GAP-PTH)

Conditions
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Post-Traumatic Headache

Intervention / Treatment
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* Device: gammaCore Sapphire
* Device: sham gammaCore Sapphire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets the ICHD-3 criteria for acute headache attributed to mild traumatic injury to the head Experiences a minimum of 2 headaches (migraine or probable migraine phenotype) per week Presentation to clinic between 2 and 4 weeks after injury Able to provide written informed consent Exclusion Criteria: Any pre-existing primary headache disorder (with the exception of infrequent episodic tension type headache) Any contraindication to using nVNS Initiation or change in the dosage of any medication commonly used or headache prophylaxis 3 months before enrollment into the study Continuous headache at the time of enrollment PTH >4 weeks after injury Structural abnormality at the nVNS treatment site (e.g., lymphadenopathy, previous surgery, abnormal anatomy) Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia) Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial pain disorder) that, in the opinion of the Investigator, may confound the study assessments Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure) or an abnormal baseline electrocardiogram (ECG) within the last year (e.g., second- or third-degree heart block, prolonged QT interval, atrial fibrillation, atrial flutter, history of ventricular tachycardia or ventricular fibrillation, clinically significant premature ventricular contraction) Known or suspected cerebrovascular disease (e.g., prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery) Previous cervical vagotomy A relative of or an employee of the Investigator or the clinical study site Previously used gammaCore

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Treatment and Prevention with active gammacore device(vagus nerve stimulator) | Device: gammaCore Sapphire<br>* non-invasive vagus nerve stimulator<br>|
| Sham Comparator: Sham<br>Treatment and Prevention with sham gammacore device(vagus nerve stimulator) | Device: sham gammaCore Sapphire<br>* sham gammaCore Sapphire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of Post Traumatic Headache | Decrease in pain between active and sham treatment groups between the baseline assessment and 60 minutes post-treatment on a subset of questions from the Sport Concussion Assessment Tool, 5th edition (SCAT5) Graded Symptom Checklist | Over 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Pain | • Decrease in pain (based on the 7-point NRS) at 30 and 120 minutes after initial treatment, for all treated attacks in the nVNS and sham treatment groups | Over 14 weeks |