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
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
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
NCT ID
NCT00833209
First Posted
January 29, 2009
Last Updated
July 31, 2012
Sponsor
University Hospital, Bordeaux
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
Learn more about this trial
Orbitofrontal Cortex (OFC) Influence on Addictive Medication Overuse Headache (MOH) Deriving From Migraine
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