Diurnal Variations of Brain Metabolite Concentrations in 1H-MRS (Dyn24)

Diurnal Variations of Cerebral Metabolite Concentrations in Proton Magnetic Resonance Spectroscopy

Proton Magnetic Resonance Spectroscopy (1H-MRS) is a magnetic resonance imaging (MRI) technique. It allows the quantification of cerebral metabolite concentrations. Currently, MRS-1H is used regardless of the examination schedule. However, it is not possible to say if the brain metabolite concentrations are stable over 24 hours. Thus, the main objective was to study the diurnal variation of cerebral metabolite concentrations in 1H-MRS in healthy subjects.

Moreover, the investigators also want to investigate the association between choline concentrations (Cho, parameter reflecting membrane metabolism) in 1H-MRS and fractional anisotropy (AF) values, obtained with the diffusion tensor imaging sequence (DTI), in the white matter of the centrum ovale. The results obtained from this objective will allow to obtain reference values of an estimate of the association between Cho concentrations and AF values in healthy subjects. These data are intended to improve the diagnostic and therapeutic management of patients with neurological pathologies.

Study Overview

• Status: Completed
• Conditions: Diurnal Variations of Cerebral Metabolite
• Intervention / Treatment: Other: magnetic resonance spectroscopy (MRI)

Detailed Description

Currently, it is not possible to say if the brain metabolite concentrations are stable over 24 hours in 1H-MRS. Few studies, with small samples (< 10 subjects), have investigated this point. Their conclusions remain inconsistent. Without an available study with sufficient statistical power, it is not currently possible to state that concentrations of brain metabolites are stable over 24 hours. Therefore, it is not possible to formally conclude on differences in concentrations of metabolites between a healthy subject and a patient.

It is known that the human circadian rhythm leads to changes on many parameters such as hormonal secretions (TSH, cortisol, melatonin, growth hormone, and carbohydrate metabolism) and body temperature. It therefore seemed relevant to choose 3 of the most critical periods of the human circadian rhythm (7:30, 13:30 and 18:00) to assess the diurnal variations of cerebral metabolite in 1H-MRS. The DTI sequence will only be performed once.

The study will take place at the University Hospital of Poitiers, in the department of Medical Imaging. 3 appointments are planned: the pre-inclusion one D0, the inclusion one D1 including the signature of the consent, and the D3 one for the realization of the 3 MRIs at 7:30 am, 1:30 pm and 6 pm. Each MRI scan lasts an average of 20 minutes.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Poitiers, France, 86000
    • CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 25-45 years
• Voluntary subjects, without guardianship or curatorship or subordination
• Subjects benefiting from a Social Security scheme or benefiting from it through a relative
• Informed and signed consent by the subject after a clear and fair information of the study

Exclusion Criteria:

• Age < 25 years or > 45 years
• Current participation in another clinical research study
• Subjects not benefiting from a Social Security scheme or not benefiting from it through a relative
• Subjects benefiting from enhanced protection, namely minors, pregnant women, nursing mothers, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and patients in emergencies.
• Pregnant or nursing women, women of childbearing age who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy )
• Neurological, psychiatric, endocrinological, cardiac, pulmonary disorders.
• Unbalanced sleep disorders: untreated obstructive sleep apnea, insomnia, major delayed or advanced sleep phase, shift work with irregular rhythms.
• Taking any type of treatment, except oral contraception for women.
• Any contraindication to performing an MRI examination: pregnancy, ocular metallic foreign body (accidental blisters or others); Tattooing for a part of the face or skull, pacemaker (cardiac simulator), neurostimulator, cochlear implants and in general any implanted medical equipment; metallic cardiac valve, vascular clips formerly implanted on cranial aneurysm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of diurnal variations of brain metabolite concentrations in 1H-MRS	The primary outcome is to describe the diurnal variation of N-acetylaspartate (NAA), choline (Cho), creatine (Cr), gamma-aminobutyric acid (GABA) and glutamate at 7:30 am, 1:30 pm and 6 pm, in the basal ganglia, the anterior and posterior cingulate cortex, the insular cortex, the white matter in healthy subjects. The data will be collected at D3.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
investigation of the association between Cho concentrations and AF values in the white matter of the centrum ovale.	investigation of the association between Cho concentrations and AF values in the white matter of the centrum ovale.	1 day

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Actual): May 2, 2022
• Study Completion (Actual): November 2, 2022

Study Registration Dates

• First Submitted: March 9, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Proton Magnetic Resonance Spectroscopy
• Other Study ID Numbers: 2017-A02804-49

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No