Post-Traumatic HeadacheNCT04071743
Study of Gammacore Sapphire for the Acute and Preventive Treatment of Post-Traumatic Headache (GAP-PTH)
A study testing gammaCore Sapphire in people with Post-Traumatic Headache, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Headache
- What is being tested?
- gammaCore Sapphire
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets the ICHD-3 criteria for acute headache attributed to mild traumatic injury to the head
- Experiences a minimum of 2 headaches (migraine or probable migraine phenotype) per week
- Presentation to clinic between 2 and 4 weeks after injury
- Able to provide written informed consent
Who cannot join
- Any pre-existing primary headache disorder (with the exception of infrequent episodic tension type headache)
- Any contraindication to using nVNS
- Initiation or change in the dosage of any medication commonly used or headache prophylaxis 3 months before enrollment into the study
- Continuous headache at the time of enrollment
- PTH >4 weeks after injury
- Structural abnormality at the nVNS treatment site (e.g., lymphadenopathy, previous surgery, abnormal anatomy)
Show all 13Show fewer
- Pain at the nVNS treatment site (e.g., dysesthesia, neuralgia, cervicalgia)
- 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
- 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)
- 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)
- Previous cervical vagotomy
- A relative of or an employee of the Investigator or the clinical study site
- Previously used gammaCore
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Southwestern Medical Center Dallas
Dallas, Texas, 75390-9044
About this study
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)
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.
Read the 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.
- Conditions
- Post-Traumatic Headache
- Being tested
- gammaCore Sapphire, sham gammaCore Sapphire
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gammaCore SapphireDevice
non-invasive vagus nerve stimulator
sham gammaCore SapphireDevice
sham gammaCore Sapphire
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Treatment and Prevention with active gammacore device(vagus nerve stimulator) Receives: Device: gammaCore Sapphire |
| Sham | Sham comparator | Treatment and Prevention with sham gammacore device(vagus nerve stimulator) Receives: Device: sham gammaCore Sapphire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Over 14 weeks
Secondary outcomes (1)
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
Measured: Over 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Primary Investigator left UT Southwestern and was not replaced.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ElectroCore INC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071743
- Sponsor's protocol ID
- STU-2019-0933
- Status last verified
- Mar 2020
- First submitted
- 26 Aug 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share data outside of study
Publications
Defrin R. Chronic post-traumatic headache: clinical findings and possible mechanisms. J Man Manip Ther. 2014 Feb;22(1):36-44. doi: 10.1179/2042618613Y.0000000053.
PubMed 24976746DiTommaso C, Hoffman JM, Lucas S, Dikmen S, Temkin N, Bell KR. Medication usage patterns for headache treatment after mild traumatic brain injury. Headache. 2014 Mar;54(3):511-9. doi: 10.1111/head.12254.
PubMed 24741687Lucas S. Posttraumatic Headache: Clinical Characterization and Management. Curr Pain Headache Rep. 2015 Oct;19(10):48. doi: 10.1007/s11916-015-0520-1.
PubMed 26280569Bree D, Levy D. Development of CGRP-dependent pain and headache related behaviours in a rat model of concussion: Implications for mechanisms of post-traumatic headache. Cephalalgia. 2018 Feb;38(2):246-258. doi: 10.1177/0333102416681571. Epub 2016 Dec 7.
PubMed 27899434Conidi FX. Interventional Treatment for Post-traumatic Headache. Curr Pain Headache Rep. 2016 Jun;20(6):40. doi: 10.1007/s11916-016-0570-z.
PubMed 27130542Packard RC. Treatment of chronic daily posttraumatic headache with divalproex sodium. Headache. 2000 Oct;40(9):736-9. doi: 10.1046/j.1526-4610.2000.00128.x.
PubMed 11091292Langdon R, Taraman S. Posttraumatic Headache. Pediatr Ann. 2018 Feb 1;47(2):e61-e68. doi: 10.3928/19382359-20180131-01.
PubMed 29446796Elahi F, Reddy C. High cervical epidural neurostimulation for post-traumatic headache management. Pain Physician. 2014 Jul-Aug;17(4):E537-41.
PubMed 25054404Schwedt TJ, Dodick DW, Hentz J, Trentman TL, Zimmerman RS. Occipital nerve stimulation for chronic headache--long-term safety and efficacy. Cephalalgia. 2007 Feb;27(2):153-7. doi: 10.1111/j.1468-2982.2007.01272.x.
PubMed 17257236Elahi F, Reddy C. Neuromodulation of the great auricular nerve for persistent post-traumatic headache. Pain Physician. 2014 Jul-Aug;17(4):E531-6.
PubMed 25054403Leung A, Fallah A, Shukla S, Lin L, Tsia A, Song D, Polston G, Lee R. rTMS in Alleviating Mild TBI Related Headaches--A Case Series. Pain Physician. 2016 Feb;19(2):E347-54.
PubMed 26815263Leung A, Metzger-Smith V, He Y, Cordero J, Ehlert B, Song D, Lin L, Shahrokh G, Tsai A, Vaninetti M, Rutledge T, Polston G, Sheu R, Lee R. Left Dorsolateral Prefrontal Cortex rTMS in Alleviating MTBI Related Headaches and Depressive Symptoms. Neuromodulation. 2018 Jun;21(4):390-401. doi: 10.1111/ner.12615. Epub 2017 May 30.
PubMed 28557049Howland RH. Vagus Nerve Stimulation. Curr Behav Neurosci Rep. 2014 Jun;1(2):64-73. doi: 10.1007/s40473-014-0010-5.
PubMed 24834378Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part I. Headache. 2016 Jan;56(1):71-8. doi: 10.1111/head.12647. Epub 2015 Sep 14.
PubMed 26364692Schachter SC. Vagus nerve stimulation therapy summary: five years after FDA approval. Neurology. 2002 Sep 24;59(6 Suppl 4):S15-20. doi: 10.1212/wnl.59.6_suppl_4.s15.
PubMed 12270963
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04071743
- Acronym / sponsor ID
- STU-2019-0933
- Conditions
- Post-Traumatic Headache
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Primary Investigator left UT Southwestern and was not replaced.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- ElectroCore INC
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: gammaCore SapphireTreatment and Prevention with active gammacore device(vagus nerve stimulator) |
| Sham | Sham comparator | Device: sham gammaCore SapphireTreatment and Prevention with sham gammacore device(vagus nerve stimulator) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets the ICHD-3 criteria for acute headache attributed to mild traumatic injury to the head
- Experiences a minimum of 2 headaches (migraine or probable migraine phenotype) per week
- Presentation to clinic between 2 and 4 weeks after injury
- Able to provide written informed consent
Key exclusion criteria (13 listed)
- Any pre-existing primary headache disorder (with the exception of infrequent episodic tension type headache)
- Any contraindication to using nVNS
- Initiation or change in the dosage of any medication commonly used or headache prophylaxis 3 months before enrollment into the study
- Continuous headache at the time of enrollment
- PTH >4 weeks after injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gammaCore Sapphirenon-invasive vagus nerve stimulator | Device | Treatment |
| sham gammaCore Sapphiresham gammaCore Sapphire | Device | Sham |
Primary outcome
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
1 secondary outcome
Decrease in Pain
Time frame: Over 14 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Background: PubMed 24976746Defrin R. Chronic post-traumatic headache: clinical findings and possible mechanisms. J Man Manip Ther. 2014 Feb;22(1):36-44. doi: 10.1179/2042618613Y.0000000053.
- Background: PubMed 24741687DiTommaso C, Hoffman JM, Lucas S, Dikmen S, Temkin N, Bell KR. Medication usage patterns for headache treatment after mild traumatic brain injury. Headache. 2014 Mar;54(3):511-9. doi: 10.1111/head.12254.
- Background: PubMed 26280569Lucas S. Posttraumatic Headache: Clinical Characterization and Management. Curr Pain Headache Rep. 2015 Oct;19(10):48. doi: 10.1007/s11916-015-0520-1.
- Background: PubMed 27899434Bree D, Levy D. Development of CGRP-dependent pain and headache related behaviours in a rat model of concussion: Implications for mechanisms of post-traumatic headache. Cephalalgia. 2018 Feb;38(2):246-258. doi: 10.1177/0333102416681571. Epub 2016 Dec 7.
- Background: PubMed 27130542Conidi FX. Interventional Treatment for Post-traumatic Headache. Curr Pain Headache Rep. 2016 Jun;20(6):40. doi: 10.1007/s11916-016-0570-z.
- Background: PubMed 11091292Packard RC. Treatment of chronic daily posttraumatic headache with divalproex sodium. Headache. 2000 Oct;40(9):736-9. doi: 10.1046/j.1526-4610.2000.00128.x.
- Background: PubMed 29446796Langdon R, Taraman S. Posttraumatic Headache. Pediatr Ann. 2018 Feb 1;47(2):e61-e68. doi: 10.3928/19382359-20180131-01.
- Background: PubMed 25054404Elahi F, Reddy C. High cervical epidural neurostimulation for post-traumatic headache management. Pain Physician. 2014 Jul-Aug;17(4):E537-41.
- Background: PubMed 17257236Schwedt TJ, Dodick DW, Hentz J, Trentman TL, Zimmerman RS. Occipital nerve stimulation for chronic headache--long-term safety and efficacy. Cephalalgia. 2007 Feb;27(2):153-7. doi: 10.1111/j.1468-2982.2007.01272.x.
- Background: PubMed 25054403Elahi F, Reddy C. Neuromodulation of the great auricular nerve for persistent post-traumatic headache. Pain Physician. 2014 Jul-Aug;17(4):E531-6.
- Background: PubMed 26815263Leung A, Fallah A, Shukla S, Lin L, Tsia A, Song D, Polston G, Lee R. rTMS in Alleviating Mild TBI Related Headaches--A Case Series. Pain Physician. 2016 Feb;19(2):E347-54.
- Background: PubMed 28557049Leung A, Metzger-Smith V, He Y, Cordero J, Ehlert B, Song D, Lin L, Shahrokh G, Tsai A, Vaninetti M, Rutledge T, Polston G, Sheu R, Lee R. Left Dorsolateral Prefrontal Cortex rTMS in Alleviating MTBI Related Headaches and Depressive Symptoms. Neuromodulation. 2018 Jun;21(4):390-401. doi: 10.1111/ner.12615. Epub 2017 May 30.
- Individual participant dataSharing planned: No. No plan to share data outside of study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gammaCore Sapphire in people with Post-Traumatic Headache, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of Post Traumatic Headache (time frame: Over 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04071743, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.