Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03496285
Other study ID # ACCUMBENS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 9, 2018
Est. completion date November 24, 2021

Study information

Verified date March 2022
Source Poitiers University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 24, 2021
Est. primary completion date November 24, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Radiation:
Multimodal MRI with diffusion sequence for anorexia nervosa patient
Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast
Multimodal MRI with diffusion sequence for obsessional compulsive disorder patient
Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast
Multimodal MRI with diffusion sequence for healthy volunteer
Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast

Locations

Country Name City State
France CH Laborit Poitiers

Sponsors (1)

Lead Sponsor Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fractional Anisotropy (probabilistic tractography) Evaluate the mean functional anisotropy value for fiber bundles connecting the orbito-frontal cortex and the nucleus accumbens 20 minutes
Secondary BOLD Signal (resting state) Evaluate the value of the BOLD-signal of the fiber bundles connecting the orbito-frontal cortex and the nucleus accumbens 20 minutes