Accumbo Frontal TractACCUMBENSNCT03496285
Accumbofrontal Tract Study in 2 Populations of Patients With Anorexia Nervosa and Obsessional Compulsive Disorder and Healthy Volunteer
A study testing Multimodal MRI with diffusion sequence for anorexia nervosa patient, Multimodal MRI with diffusion sequence for obsessional compulsive disorder patient and Multimodal MRI with diffusion sequence for healthy volunteer in people with Accumbo Frontal Tract, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Accumbo Frontal Tract
- What is being tested?
- Multimodal MRI with diffusion sequence for anorexia nervosa patient, Multimodal MRI with diffusion sequence for obsessional compulsive disorder patient and Multimodal MRI with diffusion sequence for healthy volunteer
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 9 May 2018to 24 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 ...
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Accumbo Frontal Tract
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal MRI with diffusion sequence for anorexia nervosa patientRadiation
Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast
Multimodal MRI with diffusion sequence for obsessional compulsive disorder patientRadiation
Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast
Multimodal MRI with diffusion sequence for healthy volunteerRadiation
Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Anisotropy (probabilistic tractography)
Evaluate the mean functional anisotropy value for fiber bundles connecting the orbito-frontal cortex and the nucleus accumbens
Measured: 20 minutes
Secondary outcomes (1)
BOLD Signal (resting state)
Evaluate the value of the BOLD-signal of the fiber bundles connecting the orbito-frontal cortex and the nucleus accumbens
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start9 May 2018
- Primary completion24 Nov 2021
- Study completion24 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accumbo Frontal TractStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496285
- Sponsor's protocol ID
- ACCUMBENS
- Acronym
- ACCUMBENS
- Status last verified
- Mar 2022
- First submitted
- 5 Apr 2018
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03496285
- Acronym / sponsor ID
- ACCUMBENS / ACCUMBENS
- Conditions
- Accumbo Frontal Tract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 9 May 2018 (actual)
- Primary completion
- 24 Nov 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Female patients
- Age between 18 and 65 years
- Subjects free to give their written consent
- 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
Key exclusion criteria (10 listed)
- Male
- Age <18 years or> 65 years
- Pregnancy
- Absence of free and informed consent signature
- Current processing by rTMS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal MRI with diffusion sequence for anorexia nervosa patientMultimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast | Radiation | – |
| Multimodal MRI with diffusion sequence for obsessional compulsive disorder patientMultimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast | Radiation | – |
| Multimodal MRI with diffusion sequence for healthy volunteerMultimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast | Radiation | – |
Primary outcome
Fractional Anisotropy (probabilistic tractography)
Time frame: 20 minutes
Evaluate the mean functional anisotropy value for fiber bundles connecting the orbito-frontal cortex and the nucleus accumbens
1 secondary outcome
BOLD Signal (resting state)
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal MRI with diffusion sequence for anorexia nervosa patient, Multimodal MRI with diffusion sequence for obsessional compulsive disorder patient and Multimodal MRI with diffusion sequence for healthy volunteer in people with Accumbo Frontal Tract, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional Anisotropy (probabilistic tractography) (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.