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

Not Applicable

Withdrawn

• Conditions: Post-Traumatic Headache
• Interventions: Device: gammaCore Sapphire; Device: sham gammaCore Sapphire

• Registration Number: NCT04071743
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2019-08-26
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-28
• Study Start: 2020-01-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-10
• Primary Completion: 2021-09-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	gammaCore Sapphire	Treatment and Prevention with active gammacore device(vagus nerve stimulator)
Sham	sham gammaCore Sapphire	Treatment and Prevention with sham gammacore device(vagus nerve stimulator)

Primary Outcome Measures

Name	Time	Method
Relief of Post Traumatic Headache	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

Secondary Outcome Measures

Name	Time	Method
Decrease in Pain	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

Trial Locations

Locations (1)

UT Southwestern Medical Center Dallas; 🇺🇸 Dallas, Texas, United States