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
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
OBSERVATIONAL
Enrollment
101
Phoenix VA Health Care System
Phoenix, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Mayo Clinic
Jacksonville, Florida, United States
Longitudinal Assessment of PTH Phenotype
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
Time frame: baseline with longitudinal follow-up at weeks four and sixteen
Longitudinal Assessment of Cutaneous Pain Thresholds
heat pain thresholds on the skin determined by quantitative sensory testing
Time frame: baseline with longitudinal follow-up at weeks four and sixteen
Longitudinal Assessment of Visual Pain Thresholds from Bright Light Exposure
visual pain thresholds to different light intensities
Time frame: baseline with longitudinal follow-up at weeks four and sixteen
Longitudinal Assessment of Brain MRI
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
Time frame: baseline with longitudinal follow-up at weeks four and sixteen
Longitudinal Assessment of Blood Based Biomarkers
blood-based biomarkers, including DNA and targeted serum proteins, associated with acute and persistent post-traumatic headache and response to therapy
Time frame: baseline with longitudinal follow-up at weeks four and sixteen
Longitudinal Assessment of Post-traumatic Headache Biomarkers
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
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Mayo Clinic
Rochester, Minnesota, United States
Time frame: baseline with longitudinal follow-up at weeks four and sixteen