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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00833209
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : August 1, 2012
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Medication Overuse Headache Procedure: PET (withdrawal) Procedure: Imaging Not Applicable

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)?

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
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
Procedure: Imaging
2 MRI (inclusion, 1 year) ; Iowa Gambling Task Test(inclusion) and questionnaires (inclusion)

Sham Comparator: 3
controls without any neurological disease
Procedure: Imaging
1 MRI ; Iowa Gambling Task test and questionnaires.

Primary Outcome Measures :
  1. basal cerebral metabolism using (18F)FDG-PET [ Time Frame: before withdrawal, 3 months, 1 year ]

Secondary Outcome Measures :
  1. Relapse [ Time Frame: All study long ]
  2. Magnetic Resonance Imaging data [ Time Frame: before withdrawal and at one year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
University Hospital, Bordeaux
Principal Investigator: Françoise RADAT, MD University Hospital, Bordeaux

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University Hospital, Bordeaux Identifier: NCT00833209     History of Changes
Other Study ID Numbers: CHUBX 2008/28
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: August 1, 2012
Last Verified: July 2012

Keywords provided by University Hospital, Bordeaux:
Orbitofrontal cortex
Medication Overuse Headache
Chronic headache

Additional relevant MeSH terms:
Headache Disorders, Secondary
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders
Brain Diseases
Central Nervous System Diseases