- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04369729
Investigate the Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache
A Multidisciplinary Translational Approach to Investigate the Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache - Human Studies Protocol: Individual Projects Excluding Clinical Trial
Study Overview
Status
Conditions
Detailed Description
The human studies component of this Focused Program include clinical phenotyping, neurophysiology, molecular and genetic biomarker discovery, and brain imaging. This data will be utilized to characterize post-traumatic headache and build univariate and multivariate predictive models for post-traumatic headache persistence and for the response to post-traumatic headache treatment. Some participants might be eligible to participate in the clinical trial portion of this study.The clinical trial is a double-blind, randomized, placebo-controlled investigation of erenumab for the treatment of post-traumatic headache. Participants will be randomized when PTH has been present for 35-56 days. The clinical trial component of this Focused Program is described in more detail in a separate clinicaltrials.gov record.
Follow-up questionnaires, headache diary data, pain threshold results, and brain imaging data will be collected longitudinally during the trial to assess for changes over time and associations of such changes with post-traumatic headache treatment outcomes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dani Smith
- Phone Number: 480-342-6524
- Email: smith.dani@mayo.edu
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85054
- Recruiting
- Mayo Clinic
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Principal Investigator:
- Todd Schwedt, MD
-
Contact:
- Dani Smith, M.S.
- Phone Number: 480-342-6524
- Email: smith.dani@mayo.edu
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Phoenix, Arizona, United States, 85012
- Recruiting
- Phoenix VA Health Care System
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Contact:
- Katherine Ross, PhD
- Phone Number: 7982 602-277-5551
- Email: Katherine.Ross3@va.gov
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Scottsdale, Arizona, United States, 85259
- Recruiting
- Mayo Clinic
-
Principal Investigator:
- Todd Schwedt, MD
-
Contact:
- Dani Smith, M.S.
- Phone Number: 480-342-6524
- Email: smith.dani@mayo.edu
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Florida
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Jacksonville, Florida, United States, 32224
- Not yet recruiting
- Mayo Clinic
-
Contact:
- Dylan Wood
- Phone Number: 904-953-9774
- Email: wood.dylan@mayo.edu
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Principal Investigator:
- Kevin Barrett, MD
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Minnesota
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Rochester, Minnesota, United States, 55901
- Recruiting
- Mayo Clinic
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Principal Investigator:
- Dmitry Esterov, DO
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Contact:
- Zachary Pohlkamp
- Phone Number: 507-422-0140
- Email: pohlkamp.zachary@mayo.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
POST-TRAUMATIC HEADACHE ELIGIBILITY CRITERIA
Inclusion Criteria:
- Have a diagnosis of acute PTH attributed to mild traumatic injury to the head as defined by the International Classification of Headache Disorders (ICHD-3).
- PTH onset 7-56 days prior to the time of enrollment.
- Adults 18-70 years of age.
- Willing to maintain a headache diary.
- Willing and able to return for follow-up visits.
Exclusion Criteria:
- Chronic headache (i.e. at least 15 headache days/month for more than 3 months) within 12 months prior to the mTBI that led to the current PTH, including PPTH, chronic migraine, medication overuse headache, new daily persistent headache, hemicrania continua, chronic tension-type headache.
- Diminished decision-making capacity that in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures.
- Started or changed dose of a headache preventive medication within the 3 months prior to screening.
- Use of onabotulinumtoxinA in the head, neck or face region within 6 months of screening.
- During the 6 months before screening, use of opioids or barbiturates on at least 4 days per month.
- Subjects who underwent an intervention or used a device (e.g., nerve blocks, transcranial magnetic stimulation, vagal nerve stimulation, or electrical trigeminal nerve stimulation) for headache.
- History of major psychiatric disorder such as schizophrenia and bipolar disorder.
- History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- History of positive neuroimaging findings that indicate a moderate or severe TBI.
Contraindications to magnetic resonance imaging, including, but not limited to (only for those individuals participating in the MRI portion of this research):
- Metal implants
- Aneurysm clips
- Severe claustrophobia
- Implanted electronic devices
- Insulin or infusion pump
- Cochlear/otologic/ear implant
- Non-removable prosthesis
- Implanted shunts/catheters
- Certain intrauterine devices
- Tattooed makeup
- Body piercings that cannot be removed
- Metal fragments
- Wire sutures or metal staples
Factors that reduce MR image quality and interpretability (only for those individuals participating in the MRI portion of this research):
- Dental braces or other non-removable devices (e.g., retainers)
- Prior brain surgery
- Known brain MRI abnormality that in the investigator's opinion will significantly impact MRI data.
- Sensory disorders that in the investigator's opinion might affect perception of cutaneous thermal stimuli (e.g., peripheral neuropathy) (only for those individuals undergoing pain threshold testing).
- Pregnancy
- Breastfeeding
- Currently or within 90 days prior to screening: received treatment in another drug study or an investigational device study.
HEALTHY CONTROL ELIGIBILITY CRITERIA
Inclusion Criteria:
- Adults 18-70 years of age.
- Willing and able to return for follow-up visits.
Exclusion Criteria:
- History of traumatic brain injury.
- History of migraine or other headaches (Tension-type headache up to an average of 3 days per month is allowed).
- Diminished decision-making capacity that in the investigator's opinion would interfere with the person's ability to provide informed consent and complete study procedures.
- During the 6 months before screening, use of opioids or barbiturates on an average of at least 4 days per month.
- History of major psychiatric disorder such as schizophrenia and bipolar disorder.
- History or evidence of any unstable or clinically significant medical condition, that in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Contraindications to magnetic resonance imaging, including, but not limited to:
- Metal implants
- Aneurysm clips
- Severe claustrophobia
- Implanted electronic devices
- Insulin or infusion pump
- Cochlear/otologic/ear implant
- Non-removable prosthesis
- Implanted shunts/catheters
- Certain intrauterine devices
- Tattooed makeup
- Body piercings that cannot be removed
- Metal fragments
- Wire sutures or metal staples
Factors that reduce MR image quality and interpretability:
- Dental braces or other non-removable devices (e.g., retainers)
- Prior brain surgery
- Known brain MRI abnormality that in the investigator's opinion will significantly impact MRI data.
- Sensory disorders that in the investigator's opinion might affect perception of cutaneous thermal stimuli (e.g., peripheral neuropathy).
- Pregnancy
- Breastfeeding
- Currently or within 90 days prior to screening: received treatment in another drug study or an investigational device study
- Has previously received any CGRP ligand or receptor targeted monoclonal antibody
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Post-Traumatic Headache
Individuals who have post-traumatic headache attributed to mild traumatic brain injury according to ICHD-3 diagnostic criteria
|
Healthy Control
Healthy controls will have no history of traumatic brain injury and no history of migraine or other headaches
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Longitudinal Assessment of PTH Phenotype
Time Frame: baseline with longitudinal follow-up at weeks four and sixteen
|
descriptive analysis of post-traumatic headache characteristics such as headache frequency and severity, and characteristics of associated conditions such as symptoms of sensory hypersensitivities, anxiety, depression, insomnia, autonomic dysfunction, and cognitive function
|
baseline with longitudinal follow-up at weeks four and sixteen
|
Longitudinal Assessment of Cutaneous Pain Thresholds
Time Frame: baseline with longitudinal follow-up at weeks four and sixteen
|
heat pain thresholds on the skin determined by quantitative sensory testing
|
baseline with longitudinal follow-up at weeks four and sixteen
|
Longitudinal Assessment of Visual Pain Thresholds from Bright Light Exposure
Time Frame: baseline with longitudinal follow-up at weeks four and sixteen
|
visual pain thresholds to different light intensities
|
baseline with longitudinal follow-up at weeks four and sixteen
|
Longitudinal Assessment of Brain MRI
Time Frame: baseline with longitudinal follow-up at weeks four and sixteen
|
structural brain imaging to include measures such as cortical thickness, regional volumes, brain curvature, white matter tract integrity, and functional brain imaging measures such as resting state functional connectivity and pain-induced brain activation
|
baseline with longitudinal follow-up at weeks four and sixteen
|
Longitudinal Assessment of Blood Based Biomarkers
Time Frame: baseline with longitudinal follow-up at weeks four and sixteen
|
blood-based biomarkers, including DNA and targeted serum proteins, associated with acute and persistent post-traumatic headache and response to therapy
|
baseline with longitudinal follow-up at weeks four and sixteen
|
Longitudinal Assessment of Post-traumatic Headache Biomarkers
Time Frame: baseline with longitudinal follow-up at weeks four and sixteen
|
clinical characteristics, pain thresholds, and brain imaging features as described above that are associated with acute post-traumatic headache and persistent post-traumatic headache; that predict the persistent of post-traumatic headache; and that predict and measure treatment response
|
baseline with longitudinal follow-up at weeks four and sixteen
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Todd Schwedt, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-003732
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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