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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

Tracking Information
First Submitted Date  ICMJE August 26, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date October 4, 2019
Estimated Study Start Date  ICMJE January 1, 2020
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04071743 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Gammacore Sapphire for the Acute and Preventive Treatment of Post-Traumatic Headache (GAP-PTH)
Official Title  ICMJE 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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post-Traumatic Headache
Intervention  ICMJE
  • Device: gammaCore Sapphire
    non-invasive vagus nerve stimulator
  • Device: sham gammaCore Sapphire
    sham gammaCore Sapphire
Study Arms  ICMJE
  • Active Comparator: Treatment
    Treatment and Prevention with active gammacore device(vagus nerve stimulator)
    Intervention: Device: gammaCore Sapphire
  • Sham Comparator: Sham
    Treatment and Prevention with sham gammacore device(vagus nerve stimulator)
    Intervention: Device: sham gammaCore Sapphire
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Stephen C Bunt, EdD 4693711733 stephen.bunt@utsouthwestern.edu
Contact: Bert B Vargas, MD 4802211950 bert.vargas@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04071743
Other Study ID Numbers  ICMJE STU-2019-0933
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No plan to share data outside of study
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE ElectroCore INC
Investigators  ICMJE Not Provided
PRS Account University of Texas Southwestern Medical Center
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP