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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
History of Changes
  Purpose

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 Intervention
Medication Overuse Headache
 Procedure: PET (withdrawal)
Procedure: Imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Orbitofrontal Cortex (OFC) Influence on Addictive Behaviour in Medication Overuse Headache (MOH) Deriving From Migraine

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • basal cerebral metabolism using (18F)FDG-PET [ Time Frame: before withdrawal, 3 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 53
Study Start Date: February 2009
Study Completion Date: May 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833209

Locations
France
CHU de Bordeaux - Hôpital Tastet Girard Centre Anti douleur
Bordeaux, France, 33076
C.H.U. de Bordeaux - Groupe Hospitalier Pellegrin - Service Médecine nucléaire
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Françoise RADAT, MD University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00833209     History of Changes
Other Study ID Numbers: CHUBX 2008/28
Study First Received: January 29, 2009
Last Updated: July 31, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 23, 2013