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

Medication Overuse Headache Clinical Trial

— MOH-PET  

Official title:

Orbitofrontal Cortex (OFC) Influence on Addictive Behaviour in Medication Overuse Headache (MOH) Deriving From Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833209
• Other study ID #: CHUBX 2008/28
• Status: Completed
• Phase: N/A
• First received: January 29, 2009
• Last updated: July 31, 2012
• Start date: February 2009
• Est. completion date: May 2012

Study information

• Verified date: July 2012
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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)?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: May 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Headache
• Headache Disorders, Secondary
• Medication Overuse Headache

Intervention

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)
• Imaging
2 MRI (inclusion, 1 year) ; Iowa Gambling Task Test(inclusion) and questionnaires (inclusion)
• Imaging
1 MRI ; Iowa Gambling Task test and questionnaires.

Locations

Country	Name	City	State
France	C.H.U. de Bordeaux - Groupe Hospitalier Pellegrin - Service Médecine nucléaire	Bordeaux
France	CHU de Bordeaux - Hôpital Tastet Girard Centre Anti douleur	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	basal cerebral metabolism using (18F)FDG-PET		before withdrawal, 3 months, 1 year	No
Secondary	Relapse		All study long	No
Secondary	Magnetic Resonance Imaging data		before withdrawal and at one year	No