Physiopathology, Diagnosis and Therapy of Primary Cephalalgia and Adaptive Disorders
2021년 1월 5일 업데이트: 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.
연구 개요
상태
완전한
정황
상세 설명
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.
연구 유형
관찰
등록 (실제)
15
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Pavia, 이탈리아, 27100
- Headache Science Center
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Subjects with episodic migraine without aura; patients with chronic migraine and medication overuse; healthy subjects
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Functional Connectivity (FC) changes
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Magnetic Resonance Imaging (MRI)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
- 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.
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 8월 31일
기본 완료 (실제)
2019년 3월 31일
연구 완료 (실제)
2020년 12월 15일
연구 등록 날짜
최초 제출
2020년 12월 21일
QC 기준을 충족하는 최초 제출
2021년 1월 5일
처음 게시됨 (실제)
2021년 1월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 1월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 1월 5일
마지막으로 확인됨
2020년 11월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .