Clinical trial NCT04071743: Study of Gammacore Sapphire for the Acute and Preventive Treatment of Post-Traumatic Headache (GAP-PTH)
Official title: 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: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post-Traumatic Headache
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: ElectroCore INC
First posted: 2019-08-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relief of Post Traumatic Headache
timeFrame: Over 14 weeks
Secondary outcomes:
measure: Decrease in Pain
timeFrame: Over 14 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center Dallas
state: Texas
Study officials:
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