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Trial record 29 of 247 for:    Recruiting, Not yet recruiting, Available Studies | Headache

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

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ClinicalTrials.gov Identifier: NCT04071743
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
ElectroCore INC
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Post-Traumatic Headache Device: gammaCore Sapphire Device: sham gammaCore Sapphire Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071743


Contacts
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Contact: Stephen C Bunt, EdD 4693711733 stephen.bunt@utsouthwestern.edu
Contact: Bert B Vargas, MD 4802211950 bert.vargas@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Dallas Not yet recruiting
Dallas, Texas, United States, 75390-9044
Contact: Stephen Bunt, EdD    469-371-1733    stephen.bunt@utsouthwestern.edu   
Contact: Bert Vargas, MD    4802211950    bert.vargas@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
ElectroCore INC

Publications:

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04071743     History of Changes
Other Study ID Numbers: STU-2019-0933
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data outside of study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Post-Traumatic Headache
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases