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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
non-invasive vagus nerve stimulator
sham gammaCore Sapphire
UT Southwestern Medical Center Dallas
Dallas, Texas, United States
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
Time frame: Over 14 weeks
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
Time frame: Over 14 weeks
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