NCT04409977

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

June 26, 2019

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 1, 2020

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

June 1, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

June 26, 2019

Last Update Submit

May 26, 2020

Conditions

Cluster Headache

Keywords

Primary HeadacheTrigeminal autonomic cephalgiafunctional connectivity

Outcome Measures

Primary Outcomes (1)

  • Circadian rhythmicity of the functional connectivity of the brain

    Changes from baseline in functional connectivity of the brain using whole-brain fMRI

    Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.

Secondary Outcomes (5)

  • Circadian rhythmicity of the pain threshold

    Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.

  • Circadian changes in the perfusion of the brain.

    Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.

  • Circadian rhythmicity of the autonomic system

    Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.

  • Circadian rhythmicity of the spectroscopy of the hypothalamus

    Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.

  • Circadian rhythmicity of the spectroscopy of the hypothalamus

    Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.

Study Arms (2)

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.

Diagnostic Test: MRI examination

Control group

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

Diagnostic Test: MRI examination

Interventions

MRI examinationDIAGNOSTIC_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.

Also known as: quantitative sensory testing (QST)
Control groupPatient group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from cluster headache.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Cluster HeadacheTrigeminal Autonomic Cephalalgias

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Heiko Pohl, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heiko Pohl, MD

CONTACT

+41 44 255 1856heiko.pohl@usz.ch

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2019

First Posted

June 1, 2020

Study Start

June 26, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

June 1, 2020

Record last verified: 2020-05

Locations

CH(1)