- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03496285
Accumbofrontal Tract Study in 2 Populations of Patients With Anorexia Nervosa and Obsessional Compulsive Disorder and Healthy Volunteer (ACCUMBENS)
March 29, 2022 updated by: Poitiers University Hospital
Multimodal MRI Study of Accumbofrontal Tract in Anorexia Nervosa and Obessional Compulsive Disorder : Search for Structural and Functional Changes Between Orbito-frontal Cortex and Accumbens Nucleus Subdivisions
Restrictive anorexia nervosa and TOCs are psychiatric diseases which shares a common pathophysiological substrate We hypothesize that anorexia patients and patients with OCD have structural and functional changes in the accumbofrontal tract.
The main objective of this study will be to compare the structure and the connectivity of this tract in MRI with diffusion sequences (DTI tractography) and resting-state, in 3 distinct populations of anorexic patients, patients with OCD and healthy patients.
The role of the accumbo-frontal tract in the cortico-striato-hypothalamo-cortical circuit seems to be established.
DTI tractography will allow the measurement of functional anisotropy (FA), a parameter that evaluates the diffusion of water molecules along the white matter fibers, and therefore the potential alteration of the studied tract.
Resting state sequences will allow to estimate the BOLD signal and the functionality of the tract.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Poitiers, France, 86021
- CH Laborit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female patients
- Age between 18 and 65 years
- Subjects free to give their written consent
For anorexia nervosa :
- Patients meeting the diagnostic criteria for anorexia nervosa according to DSM5 (American Psychiatric Association): low weight (<85% of expected weight for age and height), fear of gaining weight or becoming fat, distortion of body image, and amenorrhea for more than 3 months
- Treatment with at least one antidepressant and one anxiolytic
For OCD :
- Patients meeting the diagnostic criteria of OCDs according to DSM5 (American Psychiatric Association) : presence of obsessions and / or compulsions, resulting in clinically significant suffering (loss of at least one hour per day) or impairment at the social, occupational level or in another important area of life. These symptoms are not due to the physiological effects of a substance or a general medical condition and cannot be better explained by the symptoms of another psychiatric disorder.
- Patients with homogeneous OCD in obsession and compulsion.
- Normal weight compared to expected weight for age and height
- Treatment with at least one antidepressant and one anxiolytic
ForHealthy volunteer
•Normal weight compared to expected weight for age and height
Exclusion Criteria:
- Male
- Age <18 years or> 65 years
- Pregnancy
- Absence of free and informed consent signature
- Current processing by rTMS
- Somatic intercurrent pathologies: neurological, cardiological, pneumological, renal, hepatic, endocrine, metabolic disorders ...
- Mental retardation (WAIS-IV QI <70)
- Primary Amenorrhea
- Absolute contraindication or relative to the realization of a magnetic resonance imaging without injection of contrast medium
- Old or intercurrent psychotic pathology
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fractional Anisotropy (probabilistic tractography)
Time Frame: 20 minutes
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Evaluate the mean functional anisotropy value for fiber bundles connecting the orbito-frontal cortex and the nucleus accumbens
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20 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BOLD Signal (resting state)
Time Frame: 20 minutes
|
Evaluate the value of the BOLD-signal of the fiber bundles connecting the orbito-frontal cortex and the nucleus accumbens
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2018
Primary Completion (Actual)
November 24, 2021
Study Completion (Actual)
November 24, 2021
Study Registration Dates
First Submitted
April 5, 2018
First Submitted That Met QC Criteria
April 5, 2018
First Posted (Actual)
April 12, 2018
Study Record Updates
Last Update Posted (Actual)
March 31, 2022
Last Update Submitted That Met QC Criteria
March 29, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACCUMBENS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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