NCT04071743

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

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)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post-Traumatic Headache

Interventions

Type	Name	Description
DEVICE	gammaCore Sapphire	non-invasive vagus nerve stimulator
DEVICE	sham gammaCore Sapphire	sham gammaCore Sapphire

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-09-01
• Completion: 2021-12-31
• First posted: 2019-08-28
• Last updated: 2020-03-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study