Uncovering the Cognitive and Neural Mechanisms Underlying Cognitive Time

NCT06349213 | Recruiting

• 2 other identifiers: C23-192023-A02263-42
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Time processing, the ability to process and encode temporal information, is essential for cognitive functioning and for a large number of daily life activities. In particular, the processing of durations of several seconds is central to cognition, impaired in several pathologies, and has been associated with cognitive changes with advancing age. While behavioral studies have been conducted to specify the neural bases of temporal cognition and their association with other cognitive functions, the mechanisms underlying age-related changes, and individual differences, remain unknown. The project will characterize ageing effects on timing mechanisms and their neural underpinnings. Building on recent advances from neuroscience and age-related cognitive changes, the project focuses on the precision of duration processing, that declines with age, and the associated neural bases. Participants will perform a duration judgement task while (a) electroencephalography, and (b) functional magnetic resonance imaging activity are simultaneously recorded to investigate age effects on structural and functional network connectivity. In addition, striatal dopamine will be measured using a FDOPA PETscan. Evaluation of other temporal cognition processes and general cognition will also be performed. This combination offers a unique opportunity to accurately specifying the neurophysiological underpinning of aging effects on time processing changes. This project will further our understanding of the variability of cognitive performance with advancing age, and contribute to identifying new measures of temporal impairments.

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (1)

• EEG phase lag index differences between group

  Functional connectivity (EEG phase lag index (PLI) in each frequency band) differences between young and older adults during completion of the duration comparison task

  Through study completion, an average of 3 years

Study Arms (2)

Young healthy volunteers

Healthy young adults (20-35 years) will undergo the first two visits detailed above.

Radiation: FDOPA injection before PET imaging; Behavioral: Time perception tasks; Device: fMRI imaging; Device: EEG imaging

Older healthy volunteers

Healthy older adults (60-85 years) will undergo each visit detailed above (five visits in total).

Radiation: FDOPA injection before PET imaging; Behavioral: Time perception tasks; Device: fMRI imaging; Device: EEG imaging; Behavioral: 3 year follow-up

Interventions

FDOPA injection before PET imaging RADIATION

Fluorodopa labelled with fluorine 18 (physical half-life of 109.6 min) is used at a dosage of 1 to 2 MBq/kg in neuroimaging, depending on the sensitivity of the PET camera used. For these reasons, a dose of 2 MBq/kg will be administered slowly intravenously (approximately 1 minute for a maximum bolus of 10 mL). PET acquisitions will be performed at 90 minutes post-injection and will last 30 minutes. Participants will be asked to have fasted for at least 4 hours at the time of injection, with no restriction on fluid intake.

Older healthy volunteers; Young healthy volunteers

Time perception tasks BEHAVIORAL

The main tasks involves the comparison of duration to assess aging effects on the precision of temporal representations

Older healthy volunteers; Young healthy volunteers

fMRI imaging DEVICE

Imaging of brain structure during the completion of the time perception task

Older healthy volunteers; Young healthy volunteers

EEG imaging DEVICE

Recording of neural dynamics during the completion of the time perception task

Older healthy volunteers; Young healthy volunteers

3 year follow-up BEHAVIORAL

Behavioral and EEG follow-up (for older adults only)

Older healthy volunteers

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy participant with no diagnosed condition

You may qualify if:

• Membership of a social security scheme or beneficiary of such a scheme.
• At least 7 years' schooling.
• Acceptance and signature of the informed consent form
• Fluency in French (as assessed by the project leader)
• Age between 20 and 35 years inclusive for young healthy subjects, and between 60 and 85 years inclusive for elderly healthy subjects.
• Effective contraception for women of childbearing age: Contraception will be considered effective from the moment the participant declares taking an oral contraceptive, the presence of an IUD, diaphragm or contraceptive implant, or the performance of a tubal ligation or sterilisation.
• Absence of global cognitive deficit attested by a score on the MOCA scale greater than or equal to 26/30.

You may not qualify if:

• Persons under guardianship, curators or safeguard of justice.
• Pregnant women, women in labor and nursing mothers
• Chronic neurological conditions
• Uncorrected visual difficulties
• Encephalitis
• Endocrine or liver disease
• History of head trauma with loss of consciousness lasting more than one hour
• History of cancer in the last 5 years, with the exception of squamous cell carcinoma of the skin
• Presence or history of chronic alcoholism or drug addiction
• Presence of clinically significant major psychiatric disorders (according to DSM-IV-TR criteria) or symptoms that could affect the participant's ability to complete the research.
• Use of medications that may modulate the dopaminergic system (psychotropic, with the exception of sleeping pills or occasional use of anxiolytics, as decided by the principal investigator).
• Contraindications to MRI examination (pregnancy; pacemaker or neurosensory stimulator or implantable defibrillator; clip on an aneurysm or clip on a vascular malformation of the brain; intraocular or cerebral ferromagnetic foreign body; prosthesis or mobilizable ferromagnetic metal object or splinter; cochlear implant ; peripheral stimulator; neurosurgical ventriculoperitoneal shunt valves; permanent eyelid or lip make-up; jewelry or piercing that cannot be removed; certain tattoos depending on the type of ink, size and location; automated injection devices such as insulin pumps, blood glucose sensors, claustrophobia).
• Radiotracer contraindications: Hypersensitivity to product excipients, chronic alcoholism, kidney disease.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

Cyceron Boulevard Henri Becquerel

Caen, 14074, France

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Thomas Hinault, PhD

CONTACT

+33231568140; thomas.hinault@inserm.fr

Thomas Hinault, PhD

CONTACT

+33614607918; thomashinault16@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 5, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2030
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

FR (1)