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Trial record 66 of 68 for:    tpn

Spatial and Dynamic Characterization of Brain Activity for Language and Posture (Verticality) During Normal Aging. Magnetoencephalography (MEG) Study (MEG-AGING) (MEG-AGING)

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ClinicalTrials.gov Identifier: NCT04036162
Recruitment Status : Not yet recruiting
First Posted : July 29, 2019
Last Update Posted : July 29, 2019
Sponsor:
Collaborators:
Clinatec, COMMISSARIAT À L'ÉNERGIE ATOMIQUE ET AUX ÉNERGIES ALTERNATIVES (CEA)
Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Healthy Volunteers Behavioral: Cognitive tasks Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Right-handed healthy volunteers
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Spatial and Dynamic Characterization of Brain Activity for Language and Posture (Verticality) During Normal Aging. Magnetoencephalography (MEG) Study (MEG-AGING)
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Young group
Young Right-handed healthy volunteers
Behavioral: Cognitive tasks
MagnetoEncephaloGraphy (MEG) records

Experimental: Aged group
Aged Right-handed healthy volunteers
Behavioral: Cognitive tasks
MagnetoEncephaloGraphy (MEG) records




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 :

    • frontal cognitive functioning
    • anxiety and/or depressive symptoms
    • executive functions
    • verbal intelligence
    • language

    Advanced analyses of cerebral activity as measured by MEG

    • frequency time analyses via spectral decomposition (induced brain rhythms)
    • functional and effective connectivity analysis through coherence, phase locking value, and Dynamic Causal Modelling measures



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04036162


Contacts
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Contact: Emilie COUSIN, PhD 33 (0)4 76 82 58 76 cousin.emilie@gmail.com
Contact: Caroline SANDRE-BALLESTER, PhD 33 (0)4 38 78 28 51 CSandreballester@chu-grenoble.fr

Locations
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France
CHUGA Not yet recruiting
Grenoble, France, 38000
Contact: Emilie COUSIN, PhD    33 (0)4 76 82 58 76    cousin.emilie@gmail.com   
Contact: Caroline SANDRE-BALLESTER, PhD    33 (0)4 38 78 28 51    CSandreballester@chu-grenoble.fr   
Principal Investigator: Monica BACIU, MD, PhD         
Sponsors and Collaborators
University Hospital, Grenoble
Clinatec, COMMISSARIAT À L'ÉNERGIE ATOMIQUE ET AUX ÉNERGIES ALTERNATIVES (CEA)
Laboratoire de Psychologie et NeuroCognition (LPNC), Université Grenoble Alpes
Investigators
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Principal Investigator: Monica BACIU, MD, PhD CHUGA

Publications:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04036162     History of Changes
Other Study ID Numbers: 38RC18.294
2019-A01065-52 ( Other Identifier: ANSM ID RCB )
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
Aging
Task-Positive Network (TPN)
Task-Negative Network (TNN)
MagnetoEncephaloGraphy (MEG)
Verticality
Language
Hemispheric asymmetry