Physiopathology, Diagnosis and Therapy of Primary Cephalalgia and Adaptive Disorders (NCT04696510) | Clinical Trial Compass
CompletedNot Applicable
Physiopathology, Diagnosis and Therapy of Primary Cephalalgia and Adaptive Disorders
Italy15 participantsStarted 2018-08-31
Plain-language summary
The main aim of the present pilot study is to prove the possibility to use the Nitroglycerin (NTG) model to describe the pathophysiology of headache using task-free advanced Magnetic Resonance Imaging (MRI) techniques, in order to depict the static changes of the ictal and inter-ictal phase of migraine attacks vs the pain free state in healthy subjects and to compare that with the spontaneous headache attack experienced by chronic migraineurs.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Episodic migraineurs
Inclusion Criteria:
* age between 18-60 years;
* diagnosis of episodic migraine without aura developed before the age of 50;
* no current prophylactic treatment for migraine prevention;
* chronic migraineurs with medication overuse according to the ICHDIII criteria
Exclusion Criteria:
* chronic or medication-overuse headache or cluster headache diagnosis;
* any chronic pain condition or disorders other than migraine;
* an alleged diagnosis of major psychiatric disorders such as depression, bipolar affective disorder and schizophrenia;
* a diagnosis of tension type headache with a frequency of more than 5 days per month;
* any cardiovascular diseases in which the NTG use could be contraindicated;
* blood pressure hypotension, closed angle glaucoma, anaemia;
* women in child bearing, breast feeding; continuous use of benzodiazepines;
* any neuroradiological pathological findings at a previous MRI scan of the head.
Chronic migraineurs
Inclusion Criteria:
* age between 18-60 years;
* diagnosis of migraine without aura developed before the age of 50 according to the ICHD III criteria;
* currently chronic migraineurs with medication overuse according to The International Classification of Headache Disorders 3rd edition (ICHDIII) criteria.
Exclusion Criteria:
* any chronic pain condition or disorders other than migraine;
* an alleged diagnosis of major psychiatric disorders such as depression, bipolar affective disorder and schizophrenia;
* a diagnosis …
What they're measuring
1
Functional Connectivity (FC) changes
Timeframe: Up to 6 hours
Trial details
NCT IDNCT04696510
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation