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

Post-Traumatic Headache Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04071743
• Other study ID #: STU-2019-0933
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Post-Traumatic Headache

Intervention

Device:
• gammaCore Sapphire
non-invasive vagus nerve stimulator
• sham gammaCore Sapphire
sham gammaCore Sapphire

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center Dallas	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	ElectroCore INC

Country where clinical trial is conducted

United States, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of Post Traumatic Headache	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	Decrease in Pain	• 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