- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04036162
Spatial and Dynamic Characterization of Brain Activity for Language and Posture (Verticality) During Normal Aging. Magnetoencephalography (MEG) Study (MEG-AGING) (MEG-AGING)
Depending on the point of view, different definitions of aging have been proposed. Thus, at the biological level, aging corresponds to a natural physiological process that leads to the progressive degeneration of cells and the slowing down of the vital functions of a living organism. More generally, aging is a multifactorial and multidimensional process that occurs at the cognitive, social, biological or psychological level.
The primary objective of this study is to evaluate the balance between activation (Task-Positive Network : TPN-Language, L, TPN-Verticality, V) and rest (Task-Negative Network : TNN) activity during normal aging, in two domains (language and posturo-spatial perception of verticality).
Study Overview
Detailed Description
From a cognitive point of view, although healthy older people become slower to analyze information, they remain just as accurate as young adults in performing different cognitive tasks. This necessarily implies compensation processes, with new cognitive strategies and a restructuring of the brain networks underlying these processes. These compensatory phenomena are known under the general name of neurocognitive reserve.
Specific functions such as language, visuospatial skills, motor control, posture, or memory, are affected in a very variable way among the elderly. This variability involves multiple cognitive profiles rather than just one form of aging. Indeed, healthy aging can be defined cognitively in two ways, as a homogeneous or rather heterogeneous process. According to the homogeneous hypothesis of aging, the behavioral, cognitive and brain-like manifestations are similar among the elderly, without differentiation between functions. In other words, according to this hypothesis, aging would affect all the elderly and cognitive processes in the same way. Conversely, according to the heterogeneous hypothesis, significant differences should be revealed between individuals and in the same individual according to different cognitive processes. This heterogeneity is explained by multiple factors (genetic, environmental, societal, educational, or lifestyle). If neuropsychological tests or behavioral experiments (and performance of the task) allow to identify rather easily the differences encountered among the elderly in terms of cognitive heterogeneity, this differential activity at the cerebral level is more difficult to highlight. Functional neuroimaging methods and techniques can provide a pathway for this purpose, to provide both spatial information (involved brain regions) and temporal information (dynamics of brain activation) when performing cognitive tasks or when the rest period.
In this context, the magnetoencephalography (MEG) method is a preferred technique that can provide all these types of information on brain activity. Two types of networks can therefore be recorded : task-positive network (TPN) activated when the participant is involved in a task (in this project, language and posture / verticality), and task-negative network (TNN) specific to the state of rest , represented by regions that are called "deactivated". These two networks will therefore be characterized in the study by the following parameters: (a) network: set of regions involved; (b) temporal dynamics of their activity, and (c) functional connectivity between the regions of TPN and TNN.
To answer the question of homogeneity vs. heterogeneity of cognitive cerebral aging, TPNs vs. TNN will be compared in a group of healthy young adults compared to a group of healthy elderly subjects. The comparison will be made for the three categories of parameters mentioned above (a-c).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Grenoble, France, 38000
- CHUGA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy volunteers from 25 to 85 years old : young group (25-49 years) / aged group (50 to 85 years)
- Right-handed
- Signed informed consent
- French mother tongue
- Speaking fluent French
- Normal or corrected view
- Medical examination conducted prior to participation in the trial
- Registered in the French social security scheme
Exclusion Criteria:
- Contraindication to Magnetoencephalography (MEG) and/or Magnetic resonance imaging (MRI) : implanted material, claustrophobia,…
- Generally severe condition: cardiac, respiratory, hematological, kidney, liver, cancer
- Regular use of anxiolytics, sedatives, antidepressants, neuroleptics
- Psychiatric pathology characterized
- Alcohol ingestion before the exam
- All categories of protected persons (Pregnant or lactating women, persons subject to a legal protection measure, persons deprived of their liberty by judicial or administrative decision)
- Alcohol ingestion before the exam
- Participation in other ongoing clinical trial with exclusion period or in the previous week
- Score MINI MENTAL STATE EXAMINATION (MMSE) < 24
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Young group
Young Right-handed healthy volunteers
|
MagnetoEncephaloGraphy (MEG) records
|
EXPERIMENTAL: Aged group
Aged Right-handed healthy volunteers
|
MagnetoEncephaloGraphy (MEG) records
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance between activation (TPN-Language, L, TPN-Verticality, V) and rest (TNN) activity during normal aging, in two domains (language and posturo-spatial perception of verticality) recorded by magnetoencephalography (MEG)
Time Frame: 2 hours
|
Evoked and continuous magnetic fields recorded during both cognitive tasks and during the rest period
|
2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between neuropsychological scores and brain activation or functional connectivity parameters recorded by magnetoencephalography (MEG) depending on both domains studied
Time Frame: 1 hour
|
Neuropsychological scores on tests for all participants :
Advanced analyses of cerebral activity as measured by MEG
|
1 hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Monica BACIU, MD, PhD, CHUGA
Publications and helpful links
General Publications
- Hoyau E, Roux-Sibilon A, Boudiaf N, Pichat C, Cousin E, Krainik A, Jaillard A, Peyrin C, Baciu M. Aging modulates fronto-temporal cortical interactions during lexical production. A dynamic causal modeling study. Brain Lang. 2018 Sep;184:11-19. doi: 10.1016/j.bandl.2018.06.003. Epub 2018 Jun 15.
- Baciu M, Boudiaf N, Cousin E, Perrone-Bertolotti M, Pichat C, Fournet N, Chainay H, Lamalle L, Krainik A. Functional MRI evidence for the decline of word retrieval and generation during normal aging. Age (Dordr). 2016 Feb;38(1):3. doi: 10.1007/s11357-015-9857-y. Epub 2015 Dec 28.
- Boudiaf N, Laboissiere R, Cousin E, Fournet N, Krainik A, Baciu M. Behavioral evidence for a differential modulation of semantic processing and lexical production by aging: a full linear mixed-effects modeling approach. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2018 Jan;25(1):1-22. doi: 10.1080/13825585.2016.1257100. Epub 2016 Nov 24.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 38RC18.294
- 2019-A01065-52 (OTHER: ANSM ID RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on Cognitive tasks
-
Nantes University HospitalCompleted
-
Universidade Federal do Rio Grande do NorteConselho Nacional de Desenvolvimento Científico e TecnológicoCompleted
-
University of California, Los AngelesDanone Nutricia ResearchCompleted
-
University Hospital, GrenobleGrenoble Institut des NeurosciencesRecruitingCognition | Focal Brain InjuryFrance
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
Centre Hospitalier Universitaire de Saint EtienneCompletedBipolar Affective DisorderFrance
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
University of Wisconsin, MadisonNational Institute on Aging (NIA)Not yet recruiting
-
University of VigoRecruiting