Scientists investigate the roots of persistent Post-Concussion headaches

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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): 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