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

NCT04071743 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-03-10

No results posted yet for this study

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.

Conditions

  • Post-Traumatic Headache

Interventions

DEVICE

gammaCore Sapphire

non-invasive vagus nerve stimulator

DEVICE

sham gammaCore Sapphire

sham gammaCore Sapphire

Sponsors & Collaborators

  • ElectroCore INC

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-09-01
Completion
2021-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04071743 on ClinicalTrials.gov