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Physiopathology, Diagnosis and Therapy of Primary Cephalalgia and Adaptive Disorders

5 de janeiro de 2021 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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 de estudo

Observacional

Inscrição (Real)

15

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Itália
      • Pavia, Itália, 27100
        • Headache Science Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 60 anos (Adulto)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Functional Connectivity (FC) changes
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Magnetic Resonance Imaging (MRI)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

IRCCS National Neurological Institute "C. Mondino" Foundation

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

31 de agosto de 2018

Conclusão Primária (Real)

31 de março de 2019

Conclusão do estudo (Real)

15 de dezembro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

21 de dezembro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de janeiro de 2021

Primeira postagem (Real)

6 de janeiro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de janeiro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de janeiro de 2021

Última verificação

1 de novembro de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IMAGO2020

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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