Exploration of Cluster Headache in a PET-MRI Study

• Conditions: Cluster Headache, Episodic
• Interventions: Procedure: PET-MRI in pain-free remission period

• Registration Number: NCT05084469
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Observational study in PET-MRI using the 5-HT1A agonist PET radiotracer \[18F\]F13640.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-10-18
• Last Update Submitted: 2021-10-18
• Study First Posted: 2021-10-19
• Last Update Posted: 2021-10-19
• Study Start: 2021-11-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Male
• Age between 20 to 45 years old
• Weight between 50 to 90 kg
• No psychiatric or neurologic pathological history
• No cranial trauma history with loss of consciousness
• No juridical protection
• Free and informed consent
• Affiliated with a social security scheme or similar

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Exclusion Criteria

• Subject with present or past dependence on alcohol or any other addictive substance according to the DSM-IV-TR criteria, with the exception of nicotine, caffeine and cannabis
• Subject already participating in another biomedical research project or having participated for less than a year in a study using ionizing radiation
• Subject with a contraindication to MRI exams
• Subject with a contraindication to PET scans using [18F] F13640: hypersensitivity to the active substance or to one of the excipients (sodium chloride)
• Subject with a contraindication to sumatriptan
• Patients with an active infectious disease or associated serious and progressive medical pathology
• Subjects with an inability to understand or carry out the study (language barrier, obvious lack of motivation, etc...) as judged by the investigator
• Patient having exceeded the annual amount of compensation authorized for participation in research protocols.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Episodic Cluster Headache patients	PET-MRI in pain-free remission period	Patients will perform two PET-MRI scans: (1) during cluster period and (2) during pain-free remission period. Scans during cluster periods will aim to acquire data before, during and after crisis. Sumatriptan 6mg will be injected subcutaneously under PET-MRI camera to relieve patient pain.

Primary Outcome Measures

Name	Time	Method
[18F]F13640 binding	30 minutes From t=60 to t=90 after [18F]F13640 injection on each scans	Comparison of 5-HT1A density by measuring non-displaceable binding

Secondary Outcome Measures

Name	Time	Method
MRI images - BOLD signal	75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans	Comparison of functional connectivity (BOLD signal).
Change in general anxiety	day of imaging visit during cluster period up to 24 months after inclusion	Hospital Anxiety and Depression scale. Scores range from 0 to 21. Scores with 7 or less are considered as normal. Scores 8 to 10 as borderline abnormal and 11 to 21 as abnormal (case).
Evaluation of pain	During PET-MRI scans, 75 minutes from t=150 to t=225 after [18F]F13640 injection	Evaluation of pain during days of PET-MRI using a VAS projected on a screen in the camera (0= no pain; 10= pain as bad as can be)
Acute anxiety	At five points during the day : (1) before scans, (2) time =70minutes, (3) time =105minutes, (4) time=155 minutes, (5) time=240 minutes	Evaluation of acute anxiety during days of PET-MRI using a VAS questionnaire (0= no anxiety; 10= anxiety as bad as can be)
[18F]F13640 binding	75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans	Comparison of 5-HT1A density by measuring non-displaceable binding
MRI images - fMRI	75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans	Comparison of cerebral activity (fMRI)
MRI images - perfusion MRI	75 minutes from t=150 to t=225 after [18F]F13640 injection on each scans	Comparison of cerebral blood flow (perfusion MRI).
Mood changing (depression)	day of imaging visit during cluster period up to 24 months after inclusion.	Hospital Anxiety and Depression scale. Scores range from 0 to 21. Scores with 7 or less are considered as normal. Scores 8 to 10 as borderline abnormal and 11 to 21 as abnormal (case).