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Investigate the Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369729
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
University of Arizona
Translational Genomics Research Institute
Arizona State University
Phoenix VA Health Care System
United States Department of Defense
Amgen
Information provided by (Responsible Party):
Todd J. Schwedt, Mayo Clinic

Brief Summary:
This is a United States Department of Defense funded Focused Program study that aims to identify mechanisms and predictors for persistent of post-traumatic headache attributed to mild traumatic brain injury, and identify methods of preventing post-traumatic headache persistence

Condition or disease
Post-Traumatic Headache

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.

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Study Type : Observational
Estimated Enrollment : 264 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Multidisciplinary Translational Approach to Investigate the Mechanisms, Predictors, and Prevention of Persistent Post-Traumatic Headache - Human Studies Protocol: Individual Projects Excluding Clinical Trial
Actual Study Start Date : September 9, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Group/Cohort
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



Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study participants will be enrolled from the Mayo Clinic and Phoenix VA Healthcare System and from the surrounding region
Criteria

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 7-28 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:

  • Episodic tension-type headache, migraine, or other headaches with at least 4 headache days/month on average over the 6 months prior to the mTBI resulting in PTH.
  • Previous history of chronic headache (i.e. at least 15 headache days/month) 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.
  • Current or prior use of preventive medications for migraine or other primary headache disorder.
  • Use of onabotulinumtoxinA in the head, neck or face region within 12 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):

    1. Metal implants
    2. Aneurysm clips
    3. Severe claustrophobia
    4. Implanted electronic devices
    5. Insulin or infusion pump
    6. Cochlear/otologic/ear implant
    7. Non-removable prosthesis
    8. Implanted shunts/catheters
    9. Certain intrauterine devices
    10. Tattooed makeup
    11. Body piercings that cannot be removed
    12. Metal fragments
    13. 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):

    1. Dental braces or other non-removable devices (e.g., retainers)
    2. Prior brain surgery
    3. 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:

    1. Metal implants
    2. Aneurysm clips
    3. Severe claustrophobia
    4. Implanted electronic devices
    5. Insulin or infusion pump
    6. Cochlear/otologic/ear implant
    7. Non-removable prosthesis
    8. Implanted shunts/catheters
    9. Certain intrauterine devices
    10. Tattooed makeup
    11. Body piercings that cannot be removed
    12. Metal fragments
    13. Wire sutures or metal staples
  • Factors that reduce MR image quality and interpretability:

    1. Dental braces or other non-removable devices (e.g., retainers)
    2. Prior brain surgery
    3. 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

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): NCT04369729


Contacts
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Contact: Teri Radam 480-342-3775 Radam.Teri@Mayo.Edu

Locations
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United States, Arizona
Phoenix VA Health Care System Not yet recruiting
Phoenix, Arizona, United States, 85012
Contact: Katherine Ross, PhD    602-277-5551 ext 7982    Katherine.Ross3@va.gov   
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Teri Radam    480-342-3775    Radam.Teri@Mayo.Edu   
Principal Investigator: Todd Schwedt, MD         
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Teri Radam    480-342-3775    Radam.Teri@Mayo.Edu   
Principal Investigator: Todd Schwedt, MD         
Sponsors and Collaborators
Mayo Clinic
University of Arizona
Translational Genomics Research Institute
Arizona State University
Phoenix VA Health Care System
United States Department of Defense
Amgen
Investigators
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Principal Investigator: Todd Schwedt Mayo Clinic
Additional Information:
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Responsible Party: Todd J. Schwedt, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04369729    
Other Study ID Numbers: 20-003732
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Post-Traumatic Headache
Headache
Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases