Circadian Changes of the Hypothalamic Activity in Patients Suffering From Cluster Headache

NCT ID: NCT04409977

Last Updated: 2020-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-26

Study Completion Date

2020-06-30

Brief Summary

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Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian rhythmicity. The aim of this study is to investigate circadian changes of the brain, the autonomic nervous system and pain processing systems.

Detailed Description

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Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian rhythmicity. The aim of this study is to investigate circadian changes in the functional connectivity, spectroscopy, iron deposition and perfusion of the brain. In addition, we plan to investigate circadian changes in the pain threshold of the brain using quantitative sensory testing (QST). Finally, we will investigate changes in the autonomic nervous system measuring the pupillary response.

Conditions

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Cluster Headache

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient group

Patients suffering from cluster headache will be included in this group. When analysing the data, the investigators will distinguish those in the in-bout period from those in the out-bout period. People in this group may participate twice: once in the in-bout and once in the out-bout period.

MRI examination

Intervention Type DIAGNOSTIC_TEST

Patient will be scanned in the MRI twice, once at noon (+/- 1 hour), once at 1 a.m. (+/- 1 hour). The investigators will search for any changes in functional connectivity, particular regarding the connection between the hypothalamus and pain-processing networks.

Control group

Participants not suffering from cluster headache will be included in this group.

MRI examination

Intervention Type DIAGNOSTIC_TEST

Patient will be scanned in the MRI twice, once at noon (+/- 1 hour), once at 1 a.m. (+/- 1 hour). The investigators will search for any changes in functional connectivity, particular regarding the connection between the hypothalamus and pain-processing networks.

Interventions

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MRI examination

Patient will be scanned in the MRI twice, once at noon (+/- 1 hour), once at 1 a.m. (+/- 1 hour). The investigators will search for any changes in functional connectivity, particular regarding the connection between the hypothalamus and pain-processing networks.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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quantitative sensory testing (QST)

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of cluster headache (CH) may enter the patient group, patients not suffering from CH may enter the control group.
* knowledge of the german language suffices to understand the information sheet and consent form
* having read, understood and signed the consent form

Exclusion Criteria

* Pregnancy
* contraindications for the MRI scan (particularly metal splinters, ferromagnetic devices and implants)
* claustrophobia
* obesity (MRI \> 35 kg/m2)
* shift working (last night shift must date back more than one week)
* jet lag (last travel over more than two time zones must date back more than one week)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Heiko Pohl, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

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University hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Heiko Pohl, MD

Role: CONTACT

+41 44 255 1856

Facility Contacts

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Heiko Pohl, MD

Role: primary

+41 44 255 1856

Other Identifiers

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2018-02389

Identifier Type: -

Identifier Source: org_study_id

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