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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 1, 2021

Detailed Description

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.

Interventions

  • Device: gammaCore Sapphire
    • non-invasive vagus nerve stimulator
  • Device: sham gammaCore Sapphire
    • sham gammaCore Sapphire

Arms, Groups and Cohorts

  • Active Comparator: Treatment
    • Treatment and Prevention with active gammacore device(vagus nerve stimulator)
  • Sham Comparator: Sham
    • Treatment and Prevention with sham gammacore device(vagus nerve stimulator)

Clinical Trial Outcome Measures

Primary Measures

  • Relief of Post Traumatic Headache
    • Time Frame: Over 14 weeks
    • 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

Secondary Measures

  • Decrease in Pain
    • Time Frame: Over 14 weeks
    • • 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

Participating in This Clinical Trial

Inclusion Criteria

1. Meets the ICHD-3 criteria for acute headache attributed to mild traumatic injury to the head 2. Experiences a minimum of 2 headaches (migraine or probable migraine phenotype) per week 3. Presentation to clinic between 2 and 4 weeks after injury 4. Able to provide written informed consent Exclusion Criteria:

1. Any pre-existing primary headache disorder (with the exception of infrequent episodic tension type headache) 2. Any contraindication to using nVNS 3. Initiation or change in the dosage of any medication commonly used or headache prophylaxis 3 months before enrollment into the study 4. Continuous headache at the time of enrollment 5. PTH >4 weeks after injury 6. Structural abnormality at the nVNS treatment site (e.g., lymphadenopathy, previous surgery, abnormal anatomy) 7. Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia) 8. 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 9. 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) 10. 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) 11. Previous cervical vagotomy 12. A relative of or an employee of the Investigator or the clinical study site 13. Previously used gammaCore

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Texas Southwestern Medical Center
  • Collaborator
    • ElectroCore INC
  • Provider of Information About this Clinical Study
    • Sponsor

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