High-density EEG Evaluation of Functional Connectivity Changes in Migraine Patients Receiving Advanced Preventive Therapies (Anti-CGRP mAbs)
Sponsor study identifier
observational
60
1 country
1
Study Start
January 14, 2020
Actual (reported)Primary Completion
September 1, 2023
Actual (reported)Study Completion
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 14, 2020
Actual (reported)September 1, 2023
Actual (reported)November 23, 2023
Actual (reported)December 4, 2023
Actual (reported)June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
Baseline (T0) - 3 months of mAbs treatment (T3) - 6 months of mAbs treatment (T6)
Patients with high frequency episodic or chronic migraine undergoing treatment with monoclonal antibodies directed against calcitonin gene related peptide pathway
Group of healthy controls comparable for demographic features
Monthly or quarterly mAbs administration for a year
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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).
Headache Science & Neurorehabilitation Center
Pavia, 27100, Italy
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.
Bjork 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.
First Submitted
November 23, 2023
First Posted
December 4, 2023
Study Start
January 14, 2020
Actual (reported)Primary Completion
September 1, 2023
Actual (reported)Neurophysiological and Biomolecular Effects of Atogepant in Episodic Migraine
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
Baseline (T0)
Baseline differences in absolute functional connectivity values (continuous variable, without unit of measurement) in Responders vs. Non-Responders
Baseline (T0)
Differences in monthly migraine days across 6 months of mAbs treatment (continuous variable)
Baseline (T0) - six months of mAbs treatment (T6)
Differences in monthly headache days across 6 months of mAbs treatment (continuous variable)
Baseline (T0) - six months of mAbs treatment (T6)
Differences in monthly days of acute drugs consumption across 6 months of mAbs treatment (continuous variable)
Baseline (T0) - six months of mAbs treatment (T6)
Contact the study team to confirm eligibility.
Coppola 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.
de 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.
Cao 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.
Chamanzar 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.
Semprini 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.
Aoki 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.
Study Completion
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 16, 2024
Record last verified: 2024-01
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