Orbitofrontal Cortex (OFC) Influence on Addictive Medication Overuse Headache (MOH) Deriving From Migraine (MOH-PET)
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|ClinicalTrials.gov Identifier: NCT00833209|
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : August 1, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Medication Overuse Headache||Procedure: PET (withdrawal) Procedure: Imaging||Not Applicable|
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)?
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Orbitofrontal Cortex (OFC) Influence on Addictive Behaviour in Medication Overuse Headache (MOH) Deriving From Migraine|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||May 2012|
Patients with Medication Overuse Headache (MOH)
Procedure: PET (withdrawal)
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)
Sham Comparator: 2
controls suffering from migraine
2 MRI (inclusion, 1 year) ; Iowa Gambling Task Test(inclusion) and questionnaires (inclusion)
Sham Comparator: 3
controls without any neurological disease
1 MRI ; Iowa Gambling Task test and questionnaires.
- basal cerebral metabolism using (18F)FDG-PET [ Time Frame: before withdrawal, 3 months, 1 year ]
- Relapse [ Time Frame: All study long ]
- Magnetic Resonance Imaging data [ Time Frame: before withdrawal and at one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833209
|C.H.U. de Bordeaux - Groupe Hospitalier Pellegrin - Service Médecine nucléaire|
|Bordeaux, France, 33076|
|CHU de Bordeaux - Hôpital Tastet Girard Centre Anti douleur|
|Bordeaux, France, 33076|
|Principal Investigator:||Françoise RADAT, MD||University Hospital, Bordeaux|