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临床试验/NCT06349213
NCT06349213招募中不适用

Uncovering the Cognitive and Neural Mechanisms Underlying Cognitive Time

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
130
试验地点
1
主要终点
EEG phase lag index differences between group

研究概览

简要总结

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.

详细描述

The main research examinations for all participants will be divided into two initial visits (V1: approximately 3.5 hours and V2: approximately 2.5 hours) at the GIP Cyceron (neuroimaging center) premises.

As part of the longitudinal follow-up, older participants only will complete one follow-up session (visits: V3, V4 and V5) of approximately two and a half hours per year at the PMRCI premises, for three years after visit 2.

During the various visits, participants may be accompanied by a support person of their choice.

The first visit will last approximately 3 and a half hours and will consist of two parts:

- First part of visit 1: Inclusion medical visit (V1, GIP Cyceron) The first part of Visit 1 will be carried out at GIP Cyceron after a cooling-off period of at least 7 days from the day of the telephone interview and will last approximately 1 hour. It will begin with the information and consent procedure carried out by an investigator registered with the Order of Physicians or his or her designated representative and registered on the task delegation list. Participants will be informed of the purpose, recipients and retention periods for all data collected as part of their participation in the research.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.
  • Participation in research involving exposure to ionizing radiation (nuclear medicine or radiology examinations) in the year preceding inclusion or during a period of exclusion from other research.

研究组 & 干预措施

Young healthy volunteers

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

干预措施: FDOPA injection before PET imaging (Radiation)

Young healthy volunteers

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

干预措施: Time perception tasks (Behavioral)

Young healthy volunteers

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

干预措施: fMRI imaging (Device)

Young healthy volunteers

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

干预措施: EEG imaging (Device)

Older healthy volunteers

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

干预措施: FDOPA injection before PET imaging (Radiation)

Older healthy volunteers

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

干预措施: Time perception tasks (Behavioral)

Older healthy volunteers

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

干预措施: fMRI imaging (Device)

Older healthy volunteers

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

干预措施: EEG imaging (Device)

Older healthy volunteers

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

干预措施: 3 year follow-up (Behavioral)

结局指标

主要结局

EEG phase lag index differences between group

时间窗: Through study completion, an average of 3 years

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

次要结局

未报告次要终点

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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