Accumbofrontal Tract Study in 2 Populations of Patients W... | NCT03496285

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

NCT03496285

Sponsor

Poitiers University Hospital

Status

Completed

Last Update Posted

Mar 31, 2022Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Accumbo Frontal Tract

Interventions

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

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 9, 2018Actual

Primary Completion Date

Nov 24, 2021Actual

Completion Date

Nov 24, 2021Actual

First Submitted Date

Apr 5, 2018

First Submission Date that Met QC Criteria

Apr 5, 2018

First Posted Date

Apr 12, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2022

Last Update Posted Date

Mar 31, 2022Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided