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

Primary Purpose

Medication Overuse Headache

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET (withdrawal)
Imaging
Imaging
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Medication Overuse Headache focused on measuring Orbitofrontal cortex, Medication Overuse Headache, Chronic headache, withdrawal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • C.H.U. de Bordeaux - Groupe Hospitalier Pellegrin - Service Médecine nucléaire
  • CHU de Bordeaux - Hôpital Tastet Girard Centre Anti douleur

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Sham Comparator

Arm Label

1

2

3

Arm Description

Patients with Medication Overuse Headache (MOH)

controls suffering from migraine

controls without any neurological disease

Outcomes

Primary Outcome Measures

basal cerebral metabolism using (18F)FDG-PET

Secondary Outcome Measures

Relapse
Magnetic Resonance Imaging data

Full Information

First Posted
January 29, 2009
Last Updated
July 31, 2012
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT00833209
Brief Title
Orbitofrontal Cortex (OFC) Influence on Addictive Medication Overuse Headache (MOH) Deriving From Migraine
Acronym
MOH-PET
Official Title
Orbitofrontal Cortex (OFC) Influence on Addictive Behaviour in Medication Overuse Headache (MOH) Deriving From Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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)?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medication Overuse Headache
Keywords
Orbitofrontal cortex, Medication Overuse Headache, Chronic headache, withdrawal

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients with Medication Overuse Headache (MOH)
Arm Title
2
Arm Type
Sham Comparator
Arm Description
controls suffering from migraine
Arm Title
3
Arm Type
Sham Comparator
Arm Description
controls without any neurological disease
Intervention Type
Procedure
Intervention Name(s)
PET (withdrawal)
Intervention Description
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
Intervention Name(s)
Imaging
Intervention Description
2 MRI (inclusion, 1 year) ; Iowa Gambling Task Test(inclusion) and questionnaires (inclusion)
Intervention Type
Procedure
Intervention Name(s)
Imaging
Intervention Description
1 MRI ; Iowa Gambling Task test and questionnaires.
Primary Outcome Measure Information:
Title
basal cerebral metabolism using (18F)FDG-PET
Time Frame
before withdrawal, 3 months, 1 year
Secondary Outcome Measure Information:
Title
Relapse
Time Frame
All study long
Title
Magnetic Resonance Imaging data
Time Frame
before withdrawal and at one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Françoise RADAT, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
C.H.U. de Bordeaux - Groupe Hospitalier Pellegrin - Service Médecine nucléaire
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU de Bordeaux - Hôpital Tastet Girard Centre Anti douleur
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
28390437
Citation
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.
Results Reference
derived

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

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