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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00833209
First received: January 29, 2009
Last updated: July 31, 2012
Last verified: July 2012

January 29, 2009
July 31, 2012
February 2009
July 2011   (final data collection date for primary outcome measure)
basal cerebral metabolism using (18F)FDG-PET [ Time Frame: before withdrawal, 3 months, 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00833209 on ClinicalTrials.gov Archive Site
  • Relapse [ Time Frame: All study long ] [ Designated as safety issue: No ]
  • Magnetic Resonance Imaging data [ Time Frame: before withdrawal and at one year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Orbitofrontal Cortex (OFC) Influence on Addictive Medication Overuse Headache (MOH) Deriving From Migraine
Orbitofrontal Cortex (OFC) Influence on Addictive Behaviour in Medication Overuse Headache (MOH) Deriving From Migraine

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.

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)?

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Medication Overuse Headache
  • 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)
  • Procedure: Imaging
    2 MRI (inclusion, 1 year) ; Iowa Gambling Task Test(inclusion) and questionnaires (inclusion)
  • Procedure: Imaging
    1 MRI ; Iowa Gambling Task test and questionnaires.
  • Experimental: 1
    Patients with Medication Overuse Headache (MOH)
    Intervention: Procedure: PET (withdrawal)
  • Sham Comparator: 2
    controls suffering from migraine
    Intervention: Procedure: Imaging
  • Sham Comparator: 3
    controls without any neurological disease
    Intervention: Procedure: Imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
May 2012
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00833209
CHUBX 2008/28
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Françoise RADAT, MD University Hospital, Bordeaux
University Hospital, Bordeaux
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP