Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562413
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Unraveling the Spectrum of Migraine Resistant to Treatments Searching for Novel Biological PHEnotypes and theRApeutic Approaches SPHERA Project
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPHERA_WP1_2
Brief Summary:
The investigators aim to define the neurofunctional phenotype of migraine patients who did not respond to at least 3 preventive treatments including monoclonal antibodies mAbs targeting calcitonin gene-related peptide CGRP pathway NON-responders
Primary aim will be to assess and compare changes in functional resting-state connectivity at baseline and after three months of mAbs treatment between patients who will achieve a reduction of monthly migraine days than 50 namely Responders and those who will not namely Responders
The 2 groups will undergo a neurofunctional profile by means of High Density-electroencephalogram HD-EEG and functional-magnetic resonance imaging fMRI
Primary aim will be to assess and compare changes in functional resting-state connectivity at baseline and after three months of mAbs treatment between patients who will achieve a reduction of monthly migraine days than 50 namely Responders and those who will not namely Responders
The 2 groups will undergo a neurofunctional profile by means of High Density-electroencephalogram HD-EEG and functional-magnetic resonance imaging fMRI
Detailed Description:
High Density-electroencephalogram HD-EEG and functional-magnetic resonance imaging fMRI are widely available as powerful means to non-invasively study brain connectivity features in migraine patients
They both enables to record brain activity with high spatial resolution HD-EEG also contributes to high temporal resolution while fMRI contributes to precise evaluation of deep cortical and subcortical areas relevant in migraine pathophysiology
Aim of the study is to evaluate changes in resting-state functional connectivity in patients undergoing preventive mAbs treatment using HD- EEG and fMRI These findings will allow the identification of a multibiomarkers panel signature of migraine patients resisting to specifically targeted preventive treatments and potentially unveiling other molecular targets for therapeutic approaches
STUDY DESIGN
This study is part of the SPHERA project receiving funding from the Italian Ministry of Health GR-2021-12372429 Patients will be enrolled from those attending the outpatient clinic of IRCCS Mondino Institute Pavia and Neurology Department of the University of LAquila Avezzano
The investigators will collect clinical data and perform neurofunctional profiling of migraine patients at baseline T0 and after three months of mAbs treatment T3
METHODS
All patients will undergo a resting-state functional evaluation through high density-EEG and subset of 40 patients will also be studied in parallel with fMRI at baseline
- HD-EEG the investigators will randomly acquire 4 recordings 6 minutes each in resting-state condition 2 with opened eyes and 2 with closed eyes The investigators will consider the following frequency bands delta 1-4 Hz theta 4-8 Hz alfa 8-13 Hz beta 13-30 Hz gamma 30-80 Hz
Acquisition parameters will be High-Pass 05 Hz Low-Pass 100 Hz Notch 50 Hz For analysis of HD-EEG data the investigators will use a tailored analysis pipe-line that was previously developed and validated to reconstruct neural sources from corticalsubcortical gray matter Semprini 2021 EEG signals will be band-pass filtered 1-80 Hz and down-sampled at 250 Hz Biological artifacts will be rejected using Independent Component Analysis ICA EEG signals will be referenced with a customized version of the Reference Electrode Standardization Technique REST Mantini 2007 A matrix will estimate the relationship between the measured scalp potentials and the dipoles corresponding to brain sources Sources reconstruction will be performed with the exact low-resolution brain electromagnetic tomography eLORETA algorithm
- Resting state fMRI ICA will be applied to resting state-fMRI to characterize the RSNs For each subject and for each identified RSN the mean functional connectivity will be calculated A seed based component analysis will be applied in order to obtain a whole brain map to describe the strength of the connectivity of each voxel of the brain image with the region of interest seed The region of interests selection will be based on available literature and previous experience
They both enables to record brain activity with high spatial resolution HD-EEG also contributes to high temporal resolution while fMRI contributes to precise evaluation of deep cortical and subcortical areas relevant in migraine pathophysiology
Aim of the study is to evaluate changes in resting-state functional connectivity in patients undergoing preventive mAbs treatment using HD- EEG and fMRI These findings will allow the identification of a multibiomarkers panel signature of migraine patients resisting to specifically targeted preventive treatments and potentially unveiling other molecular targets for therapeutic approaches
STUDY DESIGN
This study is part of the SPHERA project receiving funding from the Italian Ministry of Health GR-2021-12372429 Patients will be enrolled from those attending the outpatient clinic of IRCCS Mondino Institute Pavia and Neurology Department of the University of LAquila Avezzano
The investigators will collect clinical data and perform neurofunctional profiling of migraine patients at baseline T0 and after three months of mAbs treatment T3
METHODS
All patients will undergo a resting-state functional evaluation through high density-EEG and subset of 40 patients will also be studied in parallel with fMRI at baseline
- HD-EEG the investigators will randomly acquire 4 recordings 6 minutes each in resting-state condition 2 with opened eyes and 2 with closed eyes The investigators will consider the following frequency bands delta 1-4 Hz theta 4-8 Hz alfa 8-13 Hz beta 13-30 Hz gamma 30-80 Hz
Acquisition parameters will be High-Pass 05 Hz Low-Pass 100 Hz Notch 50 Hz For analysis of HD-EEG data the investigators will use a tailored analysis pipe-line that was previously developed and validated to reconstruct neural sources from corticalsubcortical gray matter Semprini 2021 EEG signals will be band-pass filtered 1-80 Hz and down-sampled at 250 Hz Biological artifacts will be rejected using Independent Component Analysis ICA EEG signals will be referenced with a customized version of the Reference Electrode Standardization Technique REST Mantini 2007 A matrix will estimate the relationship between the measured scalp potentials and the dipoles corresponding to brain sources Sources reconstruction will be performed with the exact low-resolution brain electromagnetic tomography eLORETA algorithm
- Resting state fMRI ICA will be applied to resting state-fMRI to characterize the RSNs For each subject and for each identified RSN the mean functional connectivity will be calculated A seed based component analysis will be applied in order to obtain a whole brain map to describe the strength of the connectivity of each voxel of the brain image with the region of interest seed The region of interests selection will be based on available literature and previous experience
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None