Physiopathology, Diagnosis and Therapy of Primary Cephalalgia and Adaptive Disorders

NCT04696510 | Completed

• 1 other identifier: IMAGO2020
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Keywords

Episodic migraine; Chronic migraine; Medication overuse; Nitroglycerin; fMRI

Outcome Measures

Primary Outcomes (1)

• Functional Connectivity (FC) changes

  Functional connectivity pattern of changes profiling the different condition of the migraine experience. To depict the static and dynamics changes of brain activity during a migraine attack; ii) To validate the use of the NTG-induced attacks paradigm as a reliable instrument combined with an fMRI approach to compare the induced vs the spontaneous attack; iii) To describe possible differences in brain activity between attacks in chronic and episodic migraineurs.

  Up to 6 hours

Secondary Outcomes (10)

• Magnetic Resonance Imaging (MRI)

  Up to 6 hours

• Monthly migraine frequency (day/month)

  Up to 6 hours

• Disease duration (years)

  Up to 6 hours

• Nausea (number)

  Up to 6 hours

• Vomiting (number)

  Up to 6 hours

Study Arms (3)

Chronic migraineurs

This group includes patients with chronic migraine.

Control group

This group includes healthy subjects.

Episodic migraineurs

This group includes patients with episodic migraine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with episodic migraine without aura; patients with chronic migraine and medication overuse; healthy subjects

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• 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;

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

Headache Science Center

Pavia, 27100, Italy

Location

Related Publications (7)

• 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.

  PMID: 32568433 BACKGROUND

• 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.

  PMID: 24283432 BACKGROUND

• 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.

  PMID: 27654831 BACKGROUND

• 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.

  PMID: 28853611 BACKGROUND

• 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.

  PMID: 24277718 BACKGROUND

• 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.

  PMID: 14728706 RESULT

• 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.

  PMID: 10221784 RESULT

MeSH Terms

Conditions

Migraine Disorders; Prescription Drug Overuse

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Cristina Tassorelli, Prof

  IRCCS Mondino Foundation, Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: January 6, 2021
• Study Start: August 31, 2018
• Primary Completion: March 31, 2019
• Study Completion: December 15, 2020
• Last Updated: January 6, 2021

Record last verified: 2020-11

Locations

IT (1)