Resting State Functional Connectivity in Cluster Headache

NCT06206772 | Unknown

• 1 other identifier: HD-EEG in Cluster Headache
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Cluster headache is a highly disabling primary headache disorder, characterized by severe, excruciating, recurrent unilateral headache attacks. Typically, attacks' onset displays a circadian rhythm, and bout recurrence happens in a circannual fashion. Notably, the mechanisms underlying the shift between the remission phase and cluster bout are poorly understood. Thus, the investigators aim to study brain connectivity in episodic cluster headache patients. Additionally, an explorative analysis of functional connectivity in chronic cluster headache patients will be performed.

Conditions

Cluster Headache; Headache Disorders

Outcome Measures

Primary Outcomes (2)

• Difference in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) in episodic cluster headache patients between active and remission phases

  To compare HD-EEG functional connectivity in episodic cluster headache patients between the two phases of the disease

  Through study completion, an average of 2 years

• Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) between episodic cluster headache patients and healthy controls

  To compare HD-EEG functional connectivity between episodic cluster headache patients in the two phases of the disease and healthy controls

  Through study completion, an average of 2 years

Secondary Outcomes (2)

• Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) between episodic cluster headache patients and chronic cluster headache patients

  Through study completion, an average of 1 year

• Differences in absolute functional connectivity values (continuous variable, without unit of measurement) in resting state networks (RSN-FC) between chronic cluster headache patients and healthy controls

  Single evaluation in chronic cluster headache (cCH) vs. healthy controls (HCs)

Other Outcomes (1)

• To assess for correlations between clinical features of episodic cluster headache and absolute functional connectivity values in resting state networks (RSN-FC)

  Through study completion, an average of 2 years

Study Arms (4)

Healthy subjects

Diagnostic Test: Resting state HD-EEG recording

Episodic cluster headache, active

Diagnostic Test: Resting state HD-EEG recording

Episodic cluster headache, remission

Diagnostic Test: Resting state HD-EEG recording

Chronic cluster headache

Diagnostic Test: Resting state HD-EEG recording

Interventions

Resting state HD-EEG recording DIAGNOSTIC_TEST

All subjects will be recorded with a resting state HD-EEG recording. 12 minutes in the eyes closed and 12 minutes in the eyes open condition.

Chronic cluster headache; Episodic cluster headache, active; Episodic cluster headache, remission; Healthy subjects

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with episodic and chronic cluster headache patients attending the outpatient clinic of the Headache Science \& Neurorehabilitation Center of the IRCCS Mondino Foundation (Pavia, Italy).

You may qualify if:

• Diagnosis of 3.1.1 episodic cluster headache, or 3.1.2 chronic cluster headache, according to the International Classification of Headache Disorders-3 (ICHD-3) criteria
• History of at least 1 year of disease
• For the active-phase recording (T0) in eCH, no preventive medication ongoing or verapamil at a stable dose for at least 2 weeks
• For the remission-phase recording (T1), no preventive medication ongoing, and at least 14 headache-free days since preventive discontinuation

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 psychoactive substances possibly interfering with EEG recording (eg benzodiazepines)
• Other conditions possibly influencing EEG recording
• Brain anomalies detected on MRI
• Healthy controls (HCs)
• Age and sex-matched healthy volunteers, without history of headache disorders except sporadic tension-type headache according to ICHD-3 criteria
• Previous or actual history of epilepsy
• Diagnosis of dementia o mental retardation

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

Cluster Headache; Headache Disorders

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Roberto De Icco, MD

  Headache Science ahd Neurorehabilitation Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cinzia Fattore, MD

CONTACT

0382380385; cinzia.fattore@mondino.it

Roberto De Icco, MD

CONTACT

0382 380425; roberto.deicco@mondino.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 16, 2024
• Study Start: November 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

IT (1)