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

NCT ID: NCT00833209

Last Updated: 2012-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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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)?

Conditions

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Medication Overuse Headache

Keywords

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Orbitofrontal cortex Medication Overuse Headache Chronic headache withdrawal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Patients with Medication Overuse Headache (MOH)

Group Type EXPERIMENTAL

PET (withdrawal)

Intervention Type PROCEDURE

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)

2

controls suffering from migraine

Group Type SHAM_COMPARATOR

Imaging

Intervention Type PROCEDURE

2 MRI (inclusion, 1 year) ; Iowa Gambling Task Test(inclusion) and questionnaires (inclusion)

3

controls without any neurological disease

Group Type SHAM_COMPARATOR

Imaging

Intervention Type PROCEDURE

1 MRI ; Iowa Gambling Task test and questionnaires.

Interventions

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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)

Intervention Type PROCEDURE

Imaging

2 MRI (inclusion, 1 year) ; Iowa Gambling Task Test(inclusion) and questionnaires (inclusion)

Intervention Type PROCEDURE

Imaging

1 MRI ; Iowa Gambling Task test and questionnaires.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Françoise RADAT, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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C.H.U. de Bordeaux - Groupe Hospitalier Pellegrin - Service Médecine nucléaire

Bordeaux, , France

Site Status

CHU de Bordeaux - Hôpital Tastet Girard Centre Anti douleur

Bordeaux, , France

Site Status

Countries

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France

References

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Meyer M, Di Scala G, Edde M, Dilharreguy B, Radat F, Allard M, Chanraud S. Brain structural investigation and hippocampal tractography in medication overuse headache: a native space analysis. Behav Brain Funct. 2017 Apr 8;13(1):6. doi: 10.1186/s12993-017-0124-5.

Reference Type DERIVED
PMID: 28390437 (View on PubMed)

Other Identifiers

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CHUBX 2008/28

Identifier Type: -

Identifier Source: org_study_id