HD-EEG Connectivity Changes in Migraine Patients Undergoing Treatment With Anti-CGRP mAbs

NCT06155123 | Unknown

• 1 other identifier: HD-EEG in mAbs
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Migraine Disorders; Chronic Migraine; Episodic Migraine

Keywords

migraine; anti CGRP mAbs; HD EEG; brain connectivity; resting state networks

Outcome Measures

Primary Outcomes (2)

• 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)

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

  Baseline (T0)

• Baseline differences in absolute functional connectivity values (continuous variable, without unit of measurement) in Responders vs. Non-Responders

  Baseline (T0)

Other Outcomes (5)

• 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)

Study Arms (2)

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

Drug: Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs)

Healthy Controls

Group of healthy controls comparable for demographic features

Interventions

Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs) DRUG

Monthly or quarterly mAbs administration for a year

HFEM or CM treated with mAbs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

Headache Science & Neurorehabilitation Center

Pavia, 27100, Italy

RECRUITING

Related Publications (8)

• 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.

  PMID: 29368949 BACKGROUND

• 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.

  PMID: 19705061 BACKGROUND

• 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.

  PMID: 31035929 BACKGROUND

• 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.

  PMID: 28963615 BACKGROUND

• 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.

  PMID: 27807767 BACKGROUND

• 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.

  PMID: 34258580 BACKGROUND

• 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.

  PMID: 33200500 BACKGROUND

• 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.

  PMID: 25713521 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Interventions

Ligands

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 4, 2023
• Study Start: January 14, 2020
• Primary Completion: September 1, 2023
• Study Completion: June 1, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

IT (1)