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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Withdrawn

Conditions

Post-Traumatic Headache

Treatments

Device: gammaCore Sapphire
Device: sham gammaCore Sapphire

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04071743
STU-2019-0933

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 2 patient groups

Treatment
Active Comparator group
Description:
Treatment and Prevention with active gammacore device(vagus nerve stimulator)
Treatment:
Device: gammaCore Sapphire
Sham
Sham Comparator group
Description:
Treatment and Prevention with sham gammacore device(vagus nerve stimulator)
Treatment:
Device: sham gammaCore Sapphire

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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