Physiopathology, Diagnosis and Therapy of Primary Cephalalgia and Adaptive Disorders
NCT ID: NCT04696510
Last Updated: 2021-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
15 participants
OBSERVATIONAL
2018-08-31
2020-12-15
Brief Summary
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Detailed Description
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To this end, subjects with episodic migraine (EM) without aura were enrolled. NTG-triggered a spontaneous-like migraine attack in the subjects. They underwent 4 rs-fMRI scan repetitions during different phases of the attack (baseline, prodromal, full blown, recovery phase) with a 3 Tesla MR scanner. According to the pain field literature, several regions of interests were studied, in particular the thalamic areas and the salience network (SN) were selected as primary areas of interest for the analyses. Subjects' rs-fMRI data were first processed with a seed-based correlation analysis (SCA) to assess the static changes in FC between the thalamus and the rest of the brain during the experiment. The wavelet coherence approach (WCA) were also applied to test the changes in time-in-phase coherence between the thalamus and the salience network (SN).
Healthy subject were administered nitroglycerin as well and scanned at a pain free baseline and after 3 hours in order to compare the response.
The rebound headache that followed acute drug withdrawal were used as a surrogate paradigm of spontaneous attack. Patients with chronic migraine and medication overuse were hospitalized for a supervised withdrawal program at the Mondino Foundation; during the program if they experienced a rebound headache attack, they were scanned with a rs-fMRI acquisition.
The acquired imagines were analyzed with the same procedure regarding the evaluation of static and dynamic functional connectivity fluctuation.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Chronic migraineurs
This group includes patients with chronic migraine.
No interventions assigned to this group
Control group
This group includes healthy subjects.
No interventions assigned to this group
Episodic migraineurs
This group includes patients with episodic migraine
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* age between 18-60 years;
* overall good clinical condition, no neurological findings at the physical examination.
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 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
* 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.
Healthy subjects
* history of episodic or chronic or medication-overuse headache or cluster headache diagnosis according to the International Chronic Headache Disease (ICHD) III 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 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 the baseline MRI scan of the head.
18 Years
60 Years
ALL
Yes
Sponsors
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IRCCS National Neurological Institute "C. Mondino" Foundation
OTHER
Responsible Party
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Principal Investigators
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Cristina Tassorelli, Prof
Role: PRINCIPAL_INVESTIGATOR
IRCCS Mondino Foundation, Pavia
Locations
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Headache Science Center
Pavia, , Italy
Countries
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References
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Karsan N, Bose PR, O'Daly O, Zelaya FO, Goadsby PJ. Alterations in Functional Connectivity During Different Phases of the Triggered Migraine Attack. Headache. 2020 Jul;60(7):1244-1258. doi: 10.1111/head.13865. Epub 2020 Jun 22.
Thomsen LL, Kruuse C, Iversen HK, Olesen J. A nitric oxide donor (nitroglycerin) triggers genuine migraine attacks. Eur J Neurol. 1994 Sep;1(1):73-80. doi: 10.1111/j.1468-1331.1994.tb00053.x.
Schulte LH, May A. Functional Neuroimaging in Migraine: Chances and Challenges. Headache. 2016 Oct;56(9):1474-1481. doi: 10.1111/head.12944. Epub 2016 Sep 22.
Amin FM, Hougaard A, Magon S, Sprenger T, Wolfram F, Rostrup E, Ashina M. Altered thalamic connectivity during spontaneous attacks of migraine without aura: A resting-state fMRI study. Cephalalgia. 2018 Jun;38(7):1237-1244. doi: 10.1177/0333102417729113. Epub 2017 Aug 30.
Maniyar FH, Sprenger T, Monteith T, Schankin C, Goadsby PJ. Brain activations in the premonitory phase of nitroglycerin-triggered migraine attacks. Brain. 2014 Jan;137(Pt 1):232-41. doi: 10.1093/brain/awt320. Epub 2013 Nov 25.
Sances G, Tassorelli C, Pucci E, Ghiotto N, Sandrini G, Nappi G. Reliability of the nitroglycerin provocative test in the diagnosis of neurovascular headaches. Cephalalgia. 2004 Feb;24(2):110-9. doi: 10.1111/j.1468-2982.2004.00639.x.
Tassorelli C, Joseph SA, Buzzi MG, Nappi G. The effects on the central nervous system of nitroglycerin--putative mechanisms and mediators. Prog Neurobiol. 1999 Apr;57(6):607-24. doi: 10.1016/s0301-0082(98)00071-9.
Other Identifiers
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IMAGO2020
Identifier Type: -
Identifier Source: org_study_id
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