Orbitofrontal Cortex (OFC) Influence on Addictive Medication Overuse Headache (MOH) Deriving From Migraine

Study Overview
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Brief Summary
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Medication Overuse Headache (MOH) is an illness affecting about 1,5 % of the general population. It is characterized by chronic headache occurring for at least 15 days a month, by a use of antimigraine drugs during at least 3 months for more than 10 days a month (for ergots, triptans, opiate derivates and combined analgesics) or for more than 15 days a month (for simple analgesics). The chronic headache must have occurred during the period of antimigraine drug abuse and the headache must have returned to its episodical pattern after withdrawal of antimigraine drugs. But, about 50% of the MOH patients will relapse during the first year following the antimigraine drugs withdrawal. The pathophysiology of MOH is still largely unknown, and the role of antimigraine drug abuse in the transformation from migraine through MOH is not fully understood.

Detailed Description
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We recently explored cerebral metabolism in these MOH patients using (18F)FDG-PET (Fluoro Dexoxy Glucose Positon Emission Tomography) comparing them with controls. Results showed a hypometabolism in the OFC, which persist immediately after the antimigraine drugs withdrawal. A similar pattern is observed in varied substance related disorders and should be a marker of addictive behaviour. It can be linked with difficulties in the decision-making process, which can be explored by the Iowa Gambling Task (IGT) test. Several questions are still unanswered. What will this abnormality become in the long term ? Is it predictive of susceptibility for relapse? Can it be linked to a specific psychological profile (addictive behaviour)?

Official Title
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Orbitofrontal Cortex (OFC) Influence on Addictive Behaviour in Medication Overuse Headache (MOH) Deriving From Migraine

Conditions
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Medication Overuse Headache

Intervention / Treatment
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* Procedure: PET (withdrawal)
* Procedure: Imaging
* Procedure: Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for patients : older than eighteen years suffering from MOH (ICHD-II criteria) French speaking who wish to go on a withdrawal procedure Exclusion Criteria : pregnant women or women of child bearing age who are not using contraception post traumatic headaches illnesses interfering with the central nervous system functionning psychotic disorder or current major depressive episode contraindication for PET or MRI (Magnetic Resonnance Imaging) contraindication for all prophylactic treatment for migraine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients with Medication Overuse Headache (MOH) | Procedure: PET (withdrawal)<br>* 3 (18F)FDG-PET (before withdrawal, 3 months, 1 year), 2 MRI (before withdrawal, 1 year), will take the Iowa Gambling Task Test(before withdrawal) and will answer questionnaires measuring psychological dimensions (before withdrawal, 3 months, 1 year)<br>|
| Sham Comparator: 2<br>controls suffering from migraine | Procedure: Imaging<br>* 2 MRI (inclusion, 1 year) ; Iowa Gambling Task Test(inclusion) and questionnaires (inclusion)<br>|
| Sham Comparator: 3<br>controls without any neurological disease | Procedure: Imaging<br>* 1 MRI ; Iowa Gambling Task test and questionnaires.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| basal cerebral metabolism using (18F)FDG-PET |  | before withdrawal, 3 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse |  | All study long | 
| Magnetic Resonance Imaging data |  | before withdrawal and at one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orbitofrontal cortex, Medication Overuse Headache, Chronic headache, withdrawal