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Accumbofrontal Tract Study in 2 Populations of Patients With Anorexia Nervosa and Obsessional Compulsive Disorder and Healthy Volunteer (ACCUMBENS)

Primary Purpose

Accumbo Frontal Tract

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multimodal MRI with diffusion sequence for anorexia nervosa patient
Multimodal MRI with diffusion sequence for obsessional compulsive disorder patient
Multimodal MRI with diffusion sequence for healthy volunteer
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Accumbo Frontal Tract

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • CH Laborit

Outcomes

Primary Outcome Measures

Fractional Anisotropy (probabilistic tractography)
Evaluate the mean functional anisotropy value for fiber bundles connecting the orbito-frontal cortex and the nucleus accumbens

Secondary Outcome Measures

BOLD Signal (resting state)
Evaluate the value of the BOLD-signal of the fiber bundles connecting the orbito-frontal cortex and the nucleus accumbens

Full Information

First Posted
April 5, 2018
Last Updated
March 29, 2022
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03496285
Brief Title
Accumbofrontal Tract Study in 2 Populations of Patients With Anorexia Nervosa and Obsessional Compulsive Disorder and Healthy Volunteer
Acronym
ACCUMBENS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
November 24, 2021 (Actual)
Study Completion Date
November 24, 2021 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accumbo Frontal Tract

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
Multimodal MRI with diffusion sequence for anorexia nervosa patient
Intervention Description
Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast
Intervention Type
Radiation
Intervention Name(s)
Multimodal MRI with diffusion sequence for obsessional compulsive disorder patient
Intervention Description
Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast
Intervention Type
Radiation
Intervention Name(s)
Multimodal MRI with diffusion sequence for healthy volunteer
Intervention Description
Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast
Primary Outcome Measure Information:
Title
Fractional Anisotropy (probabilistic tractography)
Description
Evaluate the mean functional anisotropy value for fiber bundles connecting the orbito-frontal cortex and the nucleus accumbens
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
BOLD Signal (resting state)
Description
Evaluate the value of the BOLD-signal of the fiber bundles connecting the orbito-frontal cortex and the nucleus accumbens
Time Frame
20 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CH Laborit
City
Poitiers
ZIP/Postal Code
86021
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Accumbofrontal Tract Study in 2 Populations of Patients With Anorexia Nervosa and Obsessional Compulsive Disorder and Healthy Volunteer

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