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

U

University Hospital of Bordeaux

Status

Completed

Conditions

Medication Overuse Headache

Treatments

Procedure: PET (withdrawal)
Procedure: Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT00833209
CHUBX 2008/28

Details and patient eligibility

About

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.

Full 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)?

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

53 participants in 3 patient groups

1
Experimental group
Description:
Patients with Medication Overuse Headache (MOH)
Treatment:
Procedure: PET (withdrawal)
2
Sham Comparator group
Description:
controls suffering from migraine
Treatment:
Procedure: Imaging
Procedure: Imaging
3
Sham Comparator group
Description:
controls without any neurological disease
Treatment:
Procedure: Imaging
Procedure: Imaging

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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