Post-Traumatic Headache
Conditions
Brief summary
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
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
DEVICEgammaCore Sapphire
non-invasive vagus nerve stimulator
DEVICEsham gammaCore Sapphire
sham gammaCore Sapphire
Sponsors
ElectroCore INC
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relief of Post Traumatic Headache | 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
| Measure | Time frame | Description |
|---|---|---|
| Decrease in Pain | 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 |
Countries
United States
Outcome results
None listed