Healthy VolunteersMEG-AGINGNCT04036162
Spatial and Dynamic Characterization of Brain Activity for Language and Posture (Verticality) During Normal Aging. Magnetoencephalography (MEG) Study (MEG-AGING)
A study testing Cognitive tasks in people with Healthy Volunteers, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cognitive tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to 22 Jun 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 25 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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).
- Conditions
- Healthy Volunteers
- Being tested
- Cognitive tasks
- Keywords
- Aging, Task-Positive Network (TPN), Task-Negative Network (TNN), MagnetoEncephaloGraphy (MEG), Verticality, Language, Hemispheric asymmetry
- Medical subject headings
- Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive tasksBehavioural
MagnetoEncephaloGraphy (MEG) records
| Study group | Role | What they receive |
|---|---|---|
| Young group | Experimental | Young Right-handed healthy volunteers Receives: Behavioral: Cognitive tasks |
| Aged group | Experimental | Aged Right-handed healthy volunteers Receives: Behavioral: Cognitive tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Oct 2019
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Right-handed healthy volunteers
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique, Laboratoire de Psychologie et NeuroCognition
- Responsible party
- Sponsor
- Investigators
- Monica BACIU, MD, PhD, Principal investigator, CHUGA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036162
- Sponsor's protocol ID
- 38RC18.294
- Other IDs
- 2019-A01065-52
- Acronym
- MEG-AGING
- Status last verified
- May 2022
- First submitted
- 25 Jul 2019
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29913316Baciu 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.
PubMed 26711670Boudiaf 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.
PubMed 27883290
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial and Dynamic Characterization of Brain Activity for Language and Posture (Verticality) During Normal Aging. Magnetoencephalography (MEG) Study (MEG-AGING)
- ClinicalTrials.gov ID
- NCT04036162
- Acronym / sponsor ID
- MEG-AGING / 38RC18.294
- Conditions
- Healthy Volunteers
- Keywords
- Aging, Task-Positive Network (TPN), Task-Negative Network (TNN), MagnetoEncephaloGraphy (MEG), Verticality, Language, Hemispheric asymmetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique, Laboratoire de Psychologie et NeuroCognition
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 29 Jul 2019 (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.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Right-handed healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| Young group | Experimental | Behavioral: Cognitive tasksYoung Right-handed healthy volunteers |
| Aged group | Experimental | Behavioral: Cognitive tasksAged Right-handed healthy volunteers |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Cognitive tasksMagnetoEncephaloGraphy (MEG) records | Behavioural | Aged group, Young group |
Primary outcome
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
1 secondary outcome
Correlation between neuropsychological scores and brain activation or functional connectivity parameters recorded by magnetoencephalography (MEG) depending on both domains studied
Time frame: 1 hour
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 9 May 2022.
- Background: PubMed 29913316Hoyau 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.
- Background: PubMed 26711670Baciu 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.
- Background: PubMed 27883290Boudiaf 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.
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Irritability
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.
Monica BACIU, MD, PhD principal investigator
CHUGA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive tasks in people with Healthy Volunteers, run by University Hospital, Grenoble 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 8 inclusion and 9 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 9 May 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04036162, which also lists 3 linked publications.
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 9 May 2022.