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Decoding Pain Sensitivity in Migraine With Multimodal Brainstem-based Neurosignature

9. April 2021 aktualisiert von: Taipei Veterans General Hospital, Taiwan
Migraine is a highly prevalent and disabling neurological disease, which has a tremendous impact on sufferers, healthcare systems, and the economy. According to the 2016 WHO report, migraine is the second leading cause of years lived with disability, greater than all other neurological diseases combined. Yet, the treatment in migraine is far from optimum; the sufferers often abuse painkillers and complicated with medication overuse headache. Migraine is characterized by the hypersensitivity of the sensory system, potentially attributed to dysfunctional pain modulatory networks located in the deep brain structures, particularly the brainstem. However, the current understanding of these deeply seated, dysregulated pain modulatory circuits in migraine is limited due to technological constraints. Besides, studies with an in-depth analysis of the clinical manifestations (i.e., deep phenotyping) are lacking, and there is no corresponding animal model readily available for translational research. In this project, the investigators propose a multimodal approach to address these issues by applying the technologies and platforms developed by our team to explore the correlation between pain sensitivity and dysregulated connectivities from brainstem to other brain regions. In this four-year project, the investigators will recruit 400 migraine patients and 200 healthy subjects. The investigators aim at decomposing the key brainstem mechanisms underlying dysmodulated pain sensitivity in migraine from 5 comprehensive perspectives: (1) clinical deep phenotyping, (2) high-resolution brainstem structural MRI and functional connectivity analysis, (3) innovative brainstem EEG signal detecting technique, (4) multimodal data fusion platform with neural network analysis, and (5) ultrahigh-resolution brainstem-based connectomes, intravital manipulations and recording, and connectome-sequencing in animal models. Moreover, the investigators will collaborate with Taiwan Semiconductor Research Institute to develop a wearable high-density EEG equipment, integrated with a System-on-Chip capable of edge-computing the signal using algorithms derived from our brainstem decoding platform. The ultimate goal is to build a real-time brainstem decoding system for clinical application.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

Migraine causes a tremendous disease burden around the world. Migraine is one of the most prevalent neurological disorders and is reported by the WHO as the second leading cause of disease-related disabilities globally (No. 1 in the population under the 50s). There has been no much change in the ranking of disability for migraine for the past two decades, reflecting an unmet need for better treatment options. Even with the recently available calcitonin-gene related peptide (CGRP)-based treatment, the treatment response versus placebo is still disappointing (6.4-17.6% in acute treatment, 10.2-23.7% in preventive treatment). There is an urgent need to push further the current understanding of the pathophysiology of migraine, based on which novel treatment strategies can be developed. The lack of appropriate research tools hinders the acceleration of migraine research. As a neurological disorder, many neuroimaging studies have been focused on brain alterations; however, the majority focused on the cerebrum. Limited by the currently available neuroimaging and electrophysiological technologies, the deep brain structures especially the brainstem involved in the sensory and nociceptive neurotransmission in migraine, such as the trigeminal nucleus, could only be investigated to a limited extent. Obviously, there is an unmet need for novel technologies that can be used to delineate structural or functional alterations in the brainstem. Elucidation of the role of these deep brain structures may fill the gap in the current understanding of migraine pathophysiology, and pave the way to precise and efficient treatment. Studies restricted to single methodologies are insufficient for the complexity of migraine. Migraine is a complex and dynamic disorder. However, most prior studies were limited to single methodologies and provided limited insights into such a multifaceted disorder. Studies with an integrated approach are lacking. An exhaustive examination of the discrete components of a phenotype, i.e., 'deep phenotyping', can help understand different aspects of its clinical manifestations, and facilitate patient classification. Coupled with neuroimaging and electrophysiological research methodologies, a multi-modal decoding approach would help identify a constellation of migraine-specific biosignatures, rather than just one. This can not only provide clues to decipher migraine pathophysiology in various dimensions but also serve as the basis of the development of a prediction algorithm that can be applied in clinical practice. To pursue the overall goal, the present project schemes as a composition of the following 5 aims:

Aim 1: Deep phenotyping for sensory processing in patients with migraine Aim 2: Brainstem-based functional and structural connectomics in migraine Aim 3: Capturing brainstem electro-neurosignature in migraine Aim 4: Constructing a data fusion platform and developing an EEG cap with a built-in analytic chip Aim 5: Exploring brainstem-based connectome sequencing in migraine animal model

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

600

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

      • Taipei, Taiwan, 112
        • Rekrutierung
        • Headache Center, Teipei Veterans General Hospital
        • Kontakt:
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Migraine:

Inclusion criteria:

  1. fulfill the diagnostic criteria of migraine in ICHD-3,
  2. 20-65 yrs,
  3. understand the study design and willing to join the study
  4. at least four headache days per month,
  5. the onset of headache is prior to 50 yrs.,
  6. normal neurological examination findings.

Exclusion criteria:

  1. history or family history of epilepsy,
  2. taking migraine prophylactics,
  3. women who are breastfeeding or pregnant,
  4. severe psychological disorders, including major depression, PTSD, personality disorders, bipolar disorder, schizophrenia,
  5. medical, neurological or psychiatric disease discovered by the researcher that would hinder the research,
  6. contraindications for MR scan (pacemaker, claustrophobia, stent, metal implants…).

Healthy:

Inclusion criteria:

  1. 20-65 yrs,
  2. normal neurological examination findings,
  3. understand the study design and willing to join the study.

Exclusion criteria:

  1. history or family history of epilepsy,
  2. women who are breastfeeding or pregnant,
  3. severe psychological disorders, including major depression, PTSD, personality disorders, bipolar disorder, schizophrenia,
  4. medical, neurological or psychiatric disease discovered by the researcher that would hinder the research,
  5. contraindications for MR scan (pacemaker, claustrophobia, stent, metal implants…),
  6. history of headache will be included (the tension-type headache occurs < 1 time per month is allowed)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: patients with migraine
patient with migraine will be prescribed with flunarizine or routine clinical care per clinician's decision based on the condition of each individual patient
The flunarizine will be given per clinical routine
Sonstiges: healthy control
no intervention for healthy control

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinical change after treatment (1) headache frequency
Zeitfenster: 6 months
clinical change (headache frequency) after treatment unit: attacks per month analysis: comparing the mean headache frequency in each month after treatment (M1/M2/M3/M4/M5/M6) to that before treatment (M0)
6 months
Clinical change after treatment (2) headache intensity
Zeitfenster: 6 months
clinical change (headache intensity) after treatment unit: NRS (numeric rating scale, 0-10) analysis: comparing the mean headache intensity in each month after treatment (M1/M2/M3/M4/M5/M6) to that before treatment (M0)
6 months
Clinical change after treatment (3) headache duration
Zeitfenster: 6 months
clinical change (headache duration) after treatment unit: hours/day analysis: comparing the mean headache duration (hours/day) in each month after treatment (M1/M2/M3/M4/M5/M6) to that before treatment (M0)
6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
EEG change after treatment (1) Linear analysis of EEG before and after treatment
Zeitfenster: 12 months

power spectral density change of EEG before and after treatment

• Four EEG sessions will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively.

12 months
EEG change after treatment (2) Nonlinear analysis of EEG before and after treatment
Zeitfenster: 12 months

functional connectivity change of EEG before and after treatment

• Four EEG sessions will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively.

12 months
EEG change after treatment (3) Nonlinear analysis of EEG before and after treatment
Zeitfenster: 12 months

evoked potential amplitude change of EEG before and after treatment

• Four EEG sessions will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively.

12 months
Sensory threshold change after treatment
Zeitfenster: 12 months

Using quantitative sensory testing (QST) to evaluate the sensory threshold before and after treatment

• Four standard QST sessions will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively.

12 months
fMRI change after treatment (1)
Zeitfenster: 12 months

functional connectivity change of fMRI before and after treatment

• Three fMRI sessions will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 6-month/12-month treatment course, respectively.

12 months
fMRI change after treatment (2)
Zeitfenster: 12 months

activation change of fMRI before and after treatment

• Three fMRI sessions will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 6-month/12-month treatment course, respectively.

12 months
MRI change after treatment (1)
Zeitfenster: 12 months

VBM changes of MRI before and after treatment

• Three MRI sessions will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 6-month/12-month treatment course, respectively.

12 months
MRI change after treatment (2)
Zeitfenster: 12 months

SBM changes of MRI before and after treatment

• Three MRI sessions will be arranged. The first one is done before treatment, and the 2nd/3rd one will be done after a 6-month/12-month treatment course, respectively.

12 months
Humoral change after treatment (1)
Zeitfenster: 12 months

Test the cytokine level using ELISA kit to evaluate the status before and after treatment

• Four blood test sessions and saliva collection will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively.

12 months
Humoral change after treatment (2)
Zeitfenster: 12 months

Test the hormone level using ELISA kit to evaluate the status before and after treatment

• Four blood test sessions and saliva collection will be arranged. The first one is done before treatment, and the 2nd/3rd/4th one will be done after a 3-month/6-month/12-month treatment course, respectively.

12 months
Genetic variance
Zeitfenster: 5 minutes

Genetic variants associated with baseline demographics and treatment response as assessed with genome-wide association study using the genotyping data derived from the Axiom Genome-wide array

• Blood draw before the treatment to extract DNA for further sequencing

5 minutes

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. Februar 2021

Primärer Abschluss (Voraussichtlich)

1. Dezember 2024

Studienabschluss (Voraussichtlich)

1. Dezember 2025

Studienanmeldedaten

Zuerst eingereicht

25. November 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Januar 2021

Zuerst gepostet (Tatsächlich)

11. Januar 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. April 2021

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. April 2021

Zuletzt verifiziert

1. April 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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