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

March 6, 2020 updated by: University of Texas Southwestern Medical Center

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390-9044
        • UT Southwestern Medical Center Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment
Treatment and Prevention with active gammacore device(vagus nerve stimulator)
Device: gammaCore Sapphire
non-invasive vagus nerve stimulator
Sham Comparator: Sham
Treatment and Prevention with sham gammacore device(vagus nerve stimulator)
Device: sham gammaCore Sapphire
sham gammaCore Sapphire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relief of Post Traumatic Headache
Time Frame: 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
Over 14 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in Pain
Time Frame: 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
Over 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

ElectroCore INC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

August 26, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2019-0933

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plan to share data outside of study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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