Migraine DisordersNCT06155123
HD-EEG Connectivity Changes in Migraine Patients Undergoing Treatment With Anti-CGRP mAbs
An observational study of Migraine Disorders and Chronic Migraine, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial summary
Migraine is a leading cause of disability with an estimated prevalence of 12% in Europe. The headache field witnessed a breakthrough since the introduction of specific preventive therapies which proved effective and well tolerated, namely the monoclonal antibodies directed against the Calcitonin Gene Related Peptide… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders, Chronic Migraine, Episodic Migraine
- What is being tested?
- Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs)
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 14 Jan 2020to Jun 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with chronic and high frequency episodic migraine attending the outpatient clinic of the Headache Science \& Neurorehabilitation Center of the IRCCS Mondino Foundation (Pavia, Italy).
Who may be able to join
- Episodic or chronic migraine diagnosis according to ICHD-3 criteria
- Indication to BoNT-A or mAbs treatment according to AIFA criteria
- Brain MRI performed within 24 months from enrolment
Who cannot join
- Previous or actual history of epilepsy
- Diagnosis of dementia o mental retardation
- Diagnosis of psychiatric illness according to Diagnostic and Statistical Manual of Mental Disorders V
- Other concomitant type of headache (except for sporadic tension type headache)
- Chronic pain conditions
- Pregnancy or breastfeeding
Show all 11Show fewer
- Concomitant use of electrical stimulators, pace-makers, metallic clips or other metallic foreign bodies
- Previous head surgery
- Ongoing neuroactive prevention therapies or other drugs, or psicoactive substances possibly interfering with EEG recording (eg benzodiazepines)
- Other conditions possibly influencing EEG recording
- Brain anomalies detected on MRI
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Headache Science & Neurorehabilitation Center
Pavia, 27100
Roberto De Icco, MD, 0382380387, roberto.deicco@mondino.it
About this study
Official title: High-density EEG Evaluation of Functional Connectivity Changes in Migraine Patients Receiving Advanced Preventive Therapies (Anti-CGRP mAbs)
Migraine is a leading cause of disability with an estimated prevalence of 12% in Europe. The headache field witnessed a breakthrough since the introduction of specific preventive therapies which proved effective and well tolerated, namely the monoclonal antibodies directed against the Calcitonin Gene Related Peptide (CGRP) pathway (mAbs). Their mechanism of action is still debated. Several Authors claimed that, despite the site of action is peripheral (namely outside of the blood brain barrier), the resulting action may take place at central level. Another valuable hypothesis is that the clinical modifications resulting from mAbs treatment may induce functional modulation of several brain areas.
With these premises, the primary aim of the study is to evaluate changes in functional connectivity in patients undergoing preventive mAbs treatment using high density EEG.
Read the detailed description
Electroencephalogram (EEG) is widely available as a powerful mean to non-invasively study brain connectivity features in migraine patients. High density EEG, by means of a minimum of 64 up to 256 electrodes, enables to record electrical brain activity with high spatial resolution. Through the analysis of brain oscillations across different frequency bands (from alpha to delta), it can evaluate sensory, pain processing and information integration, contributing to a better definition of baseline features and to detect potential markers or predictors for therapeutic interventions in an era addressed to precision medicine.
Previous neurophysiological studies focused on EEG and to assess functional connectivity or spectral analysis in migraine patients. Conventional studies found higher slow wave activity (predominantly theta) in the interictal phase and higher excitability in the visual cortex during visual aura.
In 2016 a resting state study showed a predominance of low frequency bands in the ictal phase. The interictal and ictal phases patients also presented a diffuse lower coherence, suggesting low functional connectivity. Furthermore, an altered spatial connectivity for lower alpha-band activities was found in the interictal phases during sensory stimulation by means of HD-EEG, suggesting a thalamocortical dysrhythmia.
Nowadays, targeted preventive migraine therapies are available, namely monoclonal antibodies directed against the Calcitonin Gene Related Peptide (CGRP) pathway (mAbs). They demonstrated high efficacy and tolerability in both chronic and episodic migraine. Despite their peripheral site of action (outside of the blood brain barrier), the resulting action may take place at central level or determine clinical modifications leading to a functional modulation of several brain areas.
The primary aim of the study is to evaluate changes in functional connectivity in patients undergoing preventive mAbs treatment using HD- EEG and eventual connectivity differences between Responders and Non-Responders.
Study design:
Patients will undergo visits planned at baseline (T0) and quarterly (T3-T6) during which clinical data is collected and an HD-EEG is performed. Healthy controls will undergo EEG registration once.
HD-EEG registration:
The investigators will randomly acquire 4 recordings (6 minutes each) in resting-state condition, 2 with opened eyes, and 2 with closed eyes.
Resting state FC will be analyzed among six resting state networks (Default mode network, Dorsal attention network, Ventral attention network, Language network , Somatomotor network and Visual network) in the following frequency bands: alfa 8-12 Hz, beta 13-30 Hz, gamma 31-80 Hz, theta 4-7 Hz. delta 1-3 Hz.
Acquisition parameters will be: High-Pass: 0.5 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 cortical/subcortical gray matter. 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). 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
Statistical plan:
The sample size was computed with the freeware online platform www.openepi.com. As few studies focused on functional connectivity evaluation in migraine, with no studies analyzing longitudinal changes during a specific treatment, the sample size analysis was based on the work of Bjork. The investigators thus considered as clinically meaningful a difference between groups in the theta relative power band equal to 0.04 (±0.04). Considering a two-tailed t-test for the comparison with confidence interval 95%; power: 80%, the minimum suggested sample size was 20 subjects for CM group and 20 subjects for HFEM group.
A preliminary normality analysis will be performed to decide whether to use parametric or non-parametric methods, through Shapiro Wilk test.
Numerical variables will be described as mean and standard deviation (or median and quartiles if appropriate), categorical variables as raw numbers and percentages.
Functional connectivity analyses will be conducted for separate bands and eyes closed registration.
- Conditions
- Migraine Disorders, Chronic Migraine, Episodic Migraine
- Being tested
- Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs)
- Keywords
- migraine, anti CGRP mAbs, HD EEG, brain connectivity, resting state networks
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs)Drug
Monthly or quarterly mAbs administration for a year
| Study group | Role | What they receive |
|---|---|---|
| HFEM or CM treated with mAbs | Patients with high frequency episodic or chronic migraine undergoing treatment with monoclonal antibodies directed against calcitonin gene related peptide pathway Receives: Drug: Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs) | |
| Healthy Controls | Group of healthy controls comparable for demographic features |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) in migraine group across 6 months of mAbs treatment.
To compare HD-EEG functional connectivity in migraine patients across 6 months of mAbs treatment
Measured: Baseline (T0) - 3 months of mAbs treatment (T3) - 6 months of mAbs treatment (T6)
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in Responders vs. Non-Responders across 6 months of mAbs treatment
To compare HD-EEG functional connectivity in Responders (those who achieved a reduction of Monthly migraine days > / = 50% compared to T0) vs. Non-Responders across 6 months of mAbs treatment
Measured: Baseline (T0) - 3 months of mAbs treatment (T3) - 6 months of mAbs treatment (T6)
Secondary outcomes (2)
Baseline differences in absolute functional connectivity values (continuous variable, without unit of measurement) among patients with a baseline diagnosis of HFEM vs. CM vs. healthy controls
To compare HD-EEG functional connectivity among HFEM group (patients with > / = 8 MMDs at T0) vs. CM group (patients with > / = 15 MMDs at T0) vs. healthy controls
Measured: Baseline (T0)
Baseline differences in absolute functional connectivity values (continuous variable, without unit of measurement) in Responders vs. Non-Responders
To compare HD-EEG functional connectivity in Responders (those who achieved a reduction of Monthly migraine days > / = 50% vs. T0) vs. Non-Responders at baseline
Measured: Baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start14 Jan 2020
- Primary completion1 Sep 2023
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155123
- Sponsor's protocol ID
- HD-EEG in mAbs
- Status last verified
- Jan 2024
- First submitted
- 23 Nov 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
PubMed 29368949Bjork MH, Stovner LJ, Engstrom M, Stjern M, Hagen K, Sand T. Interictal quantitative EEG in migraine: a blinded controlled study. J Headache Pain. 2009 Oct;10(5):331-9. doi: 10.1007/s10194-009-0140-4. Epub 2009 Aug 25.
PubMed 19705061Coppola G, Di Lorenzo C, Parisi V, Lisicki M, Serrao M, Pierelli F. Clinical neurophysiology of migraine with aura. J Headache Pain. 2019 Apr 29;20(1):42. doi: 10.1186/s10194-019-0997-9.
PubMed 31035929de Tommaso M, Trotta G, Vecchio E, Ricci K, Siugzdaite R, Stramaglia S. Brain networking analysis in migraine with and without aura. J Headache Pain. 2017 Sep 29;18(1):98. doi: 10.1186/s10194-017-0803-5.
PubMed 28963615Cao Z, Lin CT, Chuang CH, Lai KL, Yang AC, Fuh JL, Wang SJ. Resting-state EEG power and coherence vary between migraine phases. J Headache Pain. 2016 Dec;17(1):102. doi: 10.1186/s10194-016-0697-7. Epub 2016 Nov 2.
PubMed 27807767Chamanzar A, Haigh SM, Grover P, Behrmann M. Abnormalities in cortical pattern of coherence in migraine detected using ultra high-density EEG. Brain Commun. 2021 Apr 2;3(2):fcab061. doi: 10.1093/braincomms/fcab061. eCollection 2021.
PubMed 34258580Semprini M, Bonassi G, Barban F, Pelosin E, Iandolo R, Chiappalone M, Mantini D, Avanzino L. Modulation of neural oscillations during working memory update, maintenance, and readout: An hdEEG study. Hum Brain Mapp. 2021 Mar;42(4):1153-1166. doi: 10.1002/hbm.25283. Epub 2020 Nov 17.
PubMed 33200500Aoki Y, Ishii R, Pascual-Marqui RD, Canuet L, Ikeda S, Hata M, Imajo K, Matsuzaki H, Musha T, Asada T, Iwase M, Takeda M. Detection of EEG-resting state independent networks by eLORETA-ICA method. Front Hum Neurosci. 2015 Feb 10;9:31. doi: 10.3389/fnhum.2015.00031. eCollection 2015.
PubMed 25713521
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-density EEG Evaluation of Functional Connectivity Changes in Migraine Patients Receiving Advanced Preventive Therapies (Anti-CGRP mAbs)
- ClinicalTrials.gov ID
- NCT06155123
- Acronym / sponsor ID
- HD-EEG in mAbs
- Conditions
- Migraine Disorders, Chronic Migraine, Episodic Migraine
- Keywords
- migraine, anti CGRP mAbs, HD EEG, brain connectivity, resting state networks
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 4 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Migraine is a leading cause of disability with an estimated prevalence of 12% in Europe. The headache field witnessed a breakthrough since the introduction of specific preventive therapies which proved effective and well tolerated, namely the monoclonal antibodies directed against the Calcitonin Gene Related Peptide (CGRP) pathway (mAbs). Their mechanism of action is still debated. Several Authors claimed that, despite the site of action is peripheral (namely outside of the blood brain barrier), the resulting action may take place at central level. Another valuable hypothesis is that the clinical modifications resulting from mAbs treatment may induce functional modulation of several brain areas.
With these premises, the primary aim of the study is to evaluate changes in functional connectivity in patients undergoing preventive mAbs treatment using high density EEG.
Detailed description
Electroencephalogram (EEG) is widely available as a powerful mean to non-invasively study brain connectivity features in migraine patients. High density EEG, by means of a minimum of 64 up to 256 electrodes, enables to record electrical brain activity with high spatial resolution. Through the analysis of brain oscillations across different frequency bands (from alpha to delta), it can evaluate sensory, pain processing and information integration, contributing to a better definition of baseline features and to detect potential markers or predictors for therapeutic interventions in an era addressed to precision medicine.
Previous neurophysiological studies focused on EEG and to assess functional connectivity or spectral analysis in migraine patients. Conventional studies found higher slow wave activity (predominantly theta) in the interictal phase and higher excitability in the visual cortex during visual aura.
In 2016 a resting state study showed a predominance of low frequency bands in the ictal phase. The interictal and ictal phases patients also presented a diffuse lower coherence, suggesting low functional connectivity. Furthermore, an altered spatial connectivity for lower alpha-band activities was found in the interictal phases during sensory stimulation by means of HD-EEG, suggesting a thalamocortical dysrhythmia.
Nowadays, targeted preventive migraine therapies are available, namely monoclonal antibodies directed against the Calcitonin Gene Related Peptide (CGRP) pathway (mAbs). They demonstrated high efficacy and tolerability in both chronic and episodic migraine. Despite their peripheral site of action (outside of the blood brain barrier), the resulting action may take place at central level or determine clinical modifications leading to a functional modulation of several brain areas.
The primary aim of the study is to evaluate changes in functional connectivity in patients undergoing preventive mAbs treatment using HD- EEG and eventual connectivity differences between Responders and Non-Responders.
Study design:
Patients will undergo visits planned at baseline (T0) and quarterly (T3-T6) during which clinical data is collected and an HD-EEG is performed. Healthy controls will undergo EEG registration once.
HD-EEG registration:
The investigators will randomly acquire 4 recordings (6 minutes each) in resting-state condition, 2 with opened eyes, and 2 with closed eyes.
Resting state FC will be analyzed among six resting state networks (Default mode network, Dorsal attention network, Ventral attention network, Language network , Somatomotor network and Visual network) in the following frequency bands: alfa 8-12 Hz, beta 13-30 Hz, gamma 31-80 Hz, theta 4-7 Hz. delta 1-3 Hz.
Acquisition parameters will be: High-Pass: 0.5 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 cortical/subcortical gray matter. 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). 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
Statistical plan:
The sample size was computed with the freeware online platform www.openepi.com. As few studies focused on functional connectivity evaluation in migraine, with no studies analyzing longitudinal changes during a specific treatment, the sample size analysis was based on the work of Bjork. The investigators thus considered as clinically meaningful a difference between groups in the theta relative power band equal to 0.04 (±0.04). Considering a two-tailed t-test for the comparison with confidence interval 95%; power: 80%, the minimum suggested sample size was 20 subjects for CM group and 20 subjects for HFEM group.
A preliminary normality analysis will be performed to decide whether to use parametric or non-parametric methods, through Shapiro Wilk test.
Numerical variables will be described as mean and standard deviation (or median and quartiles if appropriate), categorical variables as raw numbers and percentages.
Functional connectivity analyses will be conducted for separate bands and eyes closed registration.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFEM or CM treated with mAbs | – | Drug: Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs)Patients with high frequency episodic or chronic migraine undergoing treatment with monoclonal antibodies directed against calcitonin gene related peptide pathway |
| Healthy Controls | – | –Group of healthy controls comparable for demographic features |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with chronic and high frequency episodic migraine attending the outpatient clinic of the Headache Science \& Neurorehabilitation Center of the IRCCS Mondino Foundation (Pavia, Italy).
Key inclusion criteria (3 listed)
- Episodic or chronic migraine diagnosis according to ICHD-3 criteria
- Indication to BoNT-A or mAbs treatment according to AIFA criteria
- Brain MRI performed within 24 months from enrolment
Key exclusion criteria (11 listed)
- Previous or actual history of epilepsy
- Diagnosis of dementia o mental retardation
- Diagnosis of psychiatric illness according to Diagnostic and Statistical Manual of Mental Disorders V
- Other concomitant type of headache (except for sporadic tension type headache)
- Chronic pain conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs)Monthly or quarterly mAbs administration for a year | Drug | HFEM or CM treated with mAbs |
Primary outcome
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) in migraine group across 6 months of mAbs treatment.
Time frame: Baseline (T0) - 3 months of mAbs treatment (T3) - 6 months of mAbs treatment (T6)
To compare HD-EEG functional connectivity in migraine patients across 6 months of mAbs treatment
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in Responders vs. Non-Responders across 6 months of mAbs treatment
Time frame: Baseline (T0) - 3 months of mAbs treatment (T3) - 6 months of mAbs treatment (T6)
To compare HD-EEG functional connectivity in Responders (those who achieved a reduction of Monthly migraine days > / = 50% compared to T0) vs. Non-Responders across 6 months of mAbs treatment
2 secondary outcomes
Baseline differences in absolute functional connectivity values (continuous variable, without unit of measurement) among patients with a baseline diagnosis of HFEM vs. CM vs. healthy controls
Time frame: Baseline (T0)
Baseline differences in absolute functional connectivity values (continuous variable, without unit of measurement) in Responders vs. Non-Responders
Time frame: Baseline (T0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Background: PubMed 29368949Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
- Background: PubMed 19705061Bjork MH, Stovner LJ, Engstrom M, Stjern M, Hagen K, Sand T. Interictal quantitative EEG in migraine: a blinded controlled study. J Headache Pain. 2009 Oct;10(5):331-9. doi: 10.1007/s10194-009-0140-4. Epub 2009 Aug 25.
- Background: PubMed 31035929Coppola G, Di Lorenzo C, Parisi V, Lisicki M, Serrao M, Pierelli F. Clinical neurophysiology of migraine with aura. J Headache Pain. 2019 Apr 29;20(1):42. doi: 10.1186/s10194-019-0997-9.
- Background: PubMed 28963615de Tommaso M, Trotta G, Vecchio E, Ricci K, Siugzdaite R, Stramaglia S. Brain networking analysis in migraine with and without aura. J Headache Pain. 2017 Sep 29;18(1):98. doi: 10.1186/s10194-017-0803-5.
- Background: PubMed 27807767Cao Z, Lin CT, Chuang CH, Lai KL, Yang AC, Fuh JL, Wang SJ. Resting-state EEG power and coherence vary between migraine phases. J Headache Pain. 2016 Dec;17(1):102. doi: 10.1186/s10194-016-0697-7. Epub 2016 Nov 2.
- Background: PubMed 34258580Chamanzar A, Haigh SM, Grover P, Behrmann M. Abnormalities in cortical pattern of coherence in migraine detected using ultra high-density EEG. Brain Commun. 2021 Apr 2;3(2):fcab061. doi: 10.1093/braincomms/fcab061. eCollection 2021.
- Background: PubMed 33200500Semprini M, Bonassi G, Barban F, Pelosin E, Iandolo R, Chiappalone M, Mantini D, Avanzino L. Modulation of neural oscillations during working memory update, maintenance, and readout: An hdEEG study. Hum Brain Mapp. 2021 Mar;42(4):1153-1166. doi: 10.1002/hbm.25283. Epub 2020 Nov 17.
- Background: PubMed 25713521Aoki Y, Ishii R, Pascual-Marqui RD, Canuet L, Ikeda S, Hata M, Imajo K, Matsuzaki H, Musha T, Asada T, Iwase M, Takeda M. Detection of EEG-resting state independent networks by eLORETA-ICA method. Front Hum Neurosci. 2015 Feb 10;9:31. doi: 10.3389/fnhum.2015.00031. eCollection 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders and Chronic Migraine, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) in migraine group across 6 months of mAbs treatment. (time frame: Baseline (T0) - 3 months of mAbs treatment (T3) - 6 months of mAbs treatment (T6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06155123, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.