Status:
COMPLETED
Clinical Characteristics and Pathophysiology of Post-Traumatic Headache
Lead Sponsor:
Danish Headache Center
Conditions:
Post-Traumatic Headache
Concussion, Mild
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
To better understand the clinical characteristics and complex pathophysiological events that constitute persistent post-traumatic headache (PPTH) and to identify possible calcitonin gene-related pepti...
Detailed Description
The present project will embark upon identifying novel PTH-specific biomarkers by incorporating a plethora of scientific approaches. First, clinical biomarkers will be assessed by deep phenotyping of ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for PPTH patients:
- 18-65 years of age
- Subject has PPTH in accordance with the diagnostic criteria of the International Headache Society (IHS)
- Concussion (mild traumatic brain injury) occured \> 12 months ago
- Subject, who are fertile women, must be on safe contraceptives
- Exclusion Criteria for PPTH patients:
- Pre-trauma existing primary headache disorder (maximum 1 day/per month with tension-type headache) and medication-overuse headache
- \> 1 episode with a sustained concussion
- Whiplash
- Pregnant or lactating women
- Cardiovascular disease of any kind
- Hypertension on the experimental day
- Hypotension on the experimental day
- Pre-trauma existing psychiatric disorder of any kind - unless well-regulated
- Any anamnestic or clinical signs of any kind deemed relevant for the study by the physician examining the subject
- Any MRI contraindication and a wish of not being informed about unexpected MRI changes
Exclusion
Key Trial Info
Start Date :
July 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03791515
Start Date
July 26 2018
End Date
December 1 2019
Last Update
January 29 2020
Active Locations (1)
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1
Danish Headache Center
Glostrup Municipality, Denmark, 2600