NCT04036162

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2021

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

July 25, 2019

Last Update Submit

May 6, 2022

Conditions

Healthy Volunteers

Keywords

AgingTask-Positive Network (TPN)Task-Negative Network (TNN)MagnetoEncephaloGraphy (MEG)VerticalityLanguageHemispheric asymmetry

Outcome Measures

Primary Outcomes (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)

    Evoked and continuous magnetic fields recorded during both cognitive tasks and during the rest period

    2 hours

Secondary Outcomes (1)

  • Correlation between neuropsychological scores and brain activation or functional connectivity parameters recorded by magnetoencephalography (MEG) depending on both domains studied

    1 hour

Study Arms (2)

Young group

EXPERIMENTAL

Young Right-handed healthy volunteers

Behavioral: Cognitive tasks

Aged group

EXPERIMENTAL

Aged Right-handed healthy volunteers

Behavioral: Cognitive tasks

Interventions

Cognitive tasksBEHAVIORAL

MagnetoEncephaloGraphy (MEG) records

Aged groupYoung group

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Score MINI MENTAL STATE EXAMINATION (MMSE) \< 24

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUGA

Grenoble, 38000, France

Location

Related Publications (3)

  • 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.

    PMID: 29913316BACKGROUND

  • 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.

    PMID: 26711670BACKGROUND

  • 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.

    PMID: 27883290BACKGROUND

MeSH Terms

Conditions

Language

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Monica BACIU, MD, PhD

    CHUGA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Right-handed healthy volunteers
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2019

First Posted

July 29, 2019

Study Start

October 1, 2019

Primary Completion

June 22, 2021

Study Completion

June 22, 2021

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations

FR(1)