Clinical trial NCT00833209: Orbitofrontal Cortex (OFC) Influence on Addictive Medication Overuse Headache (MOH) Deriving From Migraine
Official title: Orbitofrontal Cortex (OFC) Influence on Addictive Behaviour in Medication Overuse Headache (MOH) Deriving From Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Overuse Headache
Keywords: Orbitofrontal cortex
Medication Overuse Headache
Chronic headache
withdrawal
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2009-01-30
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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)?

Eligibility criteria: 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

Primary outcomes:
measure: basal cerebral metabolism using (18F)FDG-PET
timeFrame: before withdrawal, 3 months, 1 year
Secondary outcomes:
measure: Relapse
timeFrame: All study long
measure: Magnetic Resonance Imaging data
timeFrame: before withdrawal and at one year
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: C.H.U. de Bordeaux - Groupe Hospitalier Pellegrin - Service Médecine nucléaire
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Tastet Girard Centre Anti douleur
Study officials:
affiliation: University Hospital, Bordeaux
name: Françoise RADAT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer M, Di Scala G, Edde M, Dilharreguy B, Radat F, Allard M, Chanraud S. Brain structural investigation and hippocampal tractography in medication overuse headache: a native space analysis. Behav Brain Funct. 2017 Apr 8;13(1):6. doi: 10.1186/s12993-017-0124-5.