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Physiopathology, Diagnosis and Therapy of Primary Cephalalgia and Adaptive Disorders

5 gennaio 2021 aggiornato da: IRCCS National Neurological Institute "C. Mondino" Foundation

Biomarker Identification to Predict the Evolution of Migraine From an Episodic to a Chronic Condition

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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

Resting state functional magnetic resonance imaging (rs-fMRI) has depicted cyclical functional connectivity changes during the ictal and inter-ictal phase of the migraine attack. In this pilot study, Functional Connectivity (FC) changes during nitroglycerin (NTG) induced migraine attacks were assessed vs the pain-free condition in healthy subjects.

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

15

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Italia
      • Pavia, Italia, 27100
        • Headache Science Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 60 anni (Adulto)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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

Descrizione

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 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

Inclusion Criteria:

  • age between 18-60 years;
  • overall good clinical condition, no neurological findings at the physical examination.

Exclusion criteria:

  • 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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Functional Connectivity (FC) changes
Lasso di tempo: Up to 6 hours
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Magnetic Resonance Imaging (MRI)
Lasso di tempo: Up to 6 hours
To acquire sufficient MRI to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms. This can be achieved by combining clinical, psychological, biological, neurophysiological and MRI-derived features into a multimodal multi-parametric approach suitable for patient's classification. The ML and DL approaches could also be adopted to predict chronification, as well as the response to a withdrawal program for medication overuse headache.
Up to 6 hours
Monthly migraine frequency (day/month)
Lasso di tempo: Up to 6 hours
To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Disease duration (years)
Lasso di tempo: Up to 6 hours
To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Nausea (number)
Lasso di tempo: Up to 6 hours
As a feature of the migraine attack.To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Vomiting (number)
Lasso di tempo: Up to 6 hours
As a feature of the migraine attack.To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Photophobia (number)
Lasso di tempo: Up to 6 hours
As a feature of the migraine attack.To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Phonophobia (number)
Lasso di tempo: Up to 6 hours
To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Aggravation by movement (number)
Lasso di tempo: Up to 6 hours
As a feature of the migraine attack. To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Throbbing pain (number)
Lasso di tempo: Up to 6 hours
As a feature of the migraine attack. To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours
Abortive medication (number of intake/month)
Lasso di tempo: Up to 6 hours
To acquire clinical data to identify feature patterns that can profile patient's condition using machine learning (ML) and deep learning (DL) algorithms.
Up to 6 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

31 agosto 2018

Completamento primario (Effettivo)

31 marzo 2019

Completamento dello studio (Effettivo)

15 dicembre 2020

Date di iscrizione allo studio

Primo inviato

21 dicembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

5 gennaio 2021

Primo Inserito (Effettivo)

6 gennaio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 gennaio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 gennaio 2021

Ultimo verificato

1 novembre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IMAGO2020

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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