Cluster Headache, Episodic
Conditions
Keywords
Cluster Headache, PET-MRI, 5HT1A
Brief summary
Observational study in PET-MRI using the 5-HT1A agonist PET radiotracer \[18F\]F13640.
Interventions
PROCEDUREPET-MRI in pain-free remission period
Patients will performed PET-MRI scans. A first 30 minutes acquisition will be performed at time=60min after injection. A second 75 minutes acquisition will be performed at time=150min. Each scans will contain functional dynamic \[18F\]F13640 PET acquisition, anatomical and functional MRI images acquisition and pain evaluation using a score visual analogic scale.
Sponsors
Hospices Civils de Lyon
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
No
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| [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
| Measure | Time frame | Description |
|---|---|---|
| MRI images - fMRI | 30 minutes Ffrom t=60 to t=90 a after [18F]F13640 injection on each scans | Comparison of cerebral activity (fMRI) |
| MRI images - perfusion MRI | 30 minutes from t=60 to t=90 after [18F]F13640 injection on each scans | Comparison of cerebral blood flow (perfusion MRI). |
| MRI images - BOLD signal | 30 minutes from t=60 to t=90 after [18F]F13640 injection on each scans | Comparison of functional connectivity (BOLD signal). |
| [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 |
| Mood changing (depression) | baseline | 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, 30 minutes from t=60 to t=90 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) |
| Change in general anxiety | baseline | 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). |
Contacts
Primary ContactGenevieve Demarquay, MD
Backup ContactLuc Zimmer, PhD
Outcome results
None listed