NCT06110234

Brief Summary

Aging leads to cognitive changes that affect memory, particularly episodic retrieval. These impairments are detrimental to seniors' quality of life. Cognitive trainings are of great interest to the scientific community because they improve cognition in older people, and produce structural and functional changes likely to provide neuroprotection. Identifying the brain changes induced by cognitive training could therefore provide a better understanding of the neuroplastic processes of the aging brain. Some training programs aim to improve key processes underlying cognitive functioning to lead to transfer, but these most often target working memory or processing speed. Our aim is to understand the brain changes associated with a training program targeting episodic retrieval, and likely to engage a core network for memory, including the anterior hippocampus. 60 healthy older adults will be randomly divided into two groups; one receiving a training based on the Episodic Specificity Induction (ESI) - a manipulation based on a well-established police interviewing technique thought to target and facilitate episodic construction; the other receiving a control training consisting of recalling pairs of words and images. Before and after training, behavioural and brain measures will be taken. Behavioural measures will be taken during recall, recognition, and problem solving tasks. These tasks will be completed once in the ESI condition (after one ESI) and once in the NoESI condition (after a general thoughts interview). Measures of brain activation as well as static and dynamic functional connectivity (SFC \& DFC) will be taken using magnetic resonance imaging (MRI) during a recognition task. For behavioural measures, higher pre-training performance should be observed in the ESI than in the NoESI condition, and pre-to-post-training improvement should be observed only after the ESI training, especially in the NoESI condition. For brain measures, ESI training should decrease activation of the task network targeted by training, reflecting an increase in efficiency. ESI training should also increase the SFC of the task network and reduce its connectivity with the cognitive control network, suggesting more automated processing. Finally, ESI training should increase DFC by increasing the speed of transition between the networks associated with the two phases of episodic retrieval: the construction phase and the elaboration phase.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Sep 2023

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

Study Start

First participant enrolled

September 22, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

October 26, 2023

Last Update Submit

July 31, 2024

Conditions

Keywords

Memory, EpisodicAgingCognitive TrainingTransfer, PsychologyNeuropsychologyCognitive PsychologyNeurosciences

Outcome Measures

Primary Outcomes (1)

  • Changes in the number of correct specific detail recall (nearest transfer outcome)

    For the free recall task, verbal recall will be recorded and transcribed. Recalled details will be rated as specific according to the Autobiographical Interview procedure developed by Levine et al (2002). The number of specific details recalled will be measured, and the accuracy of these details will be evaluated. The number of correct specific details will be calculated by subtracting the incorrect specific details from the recalled specific details. Higher scores mean a better outcome.

    In the week preceding the start of the intervention (PRE) both in the ESI and the NoESI condition; In the week of the last intervention session (POST) both in the ESI and the NoESI condition

Secondary Outcomes (6)

  • Brain function: Memory related activation

    In the week preceding the start of the intervention (PRE); In the week of the last intervention session (POST)

  • Brain function: Memory related activation (Static functional connectivity)

    In the week preceding the start of the intervention (PRE); In the week of the last intervention session (POST)

  • Brain function: Memory related activation (Dynamic functional connectivity)

    In the week preceding the start of the intervention (PRE); In the week of the last intervention session (POST)

  • Changes in the measure of discriminability (d') (near transfer outcome) - fMRI

    In the week preceding the start of the intervention (PRE); In the week of the last intervention session (POST)

  • Changes in the number of relevant steps produced (far transfer outcome)

    In the week preceding the start of the intervention (PRE) both in the ESI and the NoESI condition; In the week of the last intervention session (POST) both in the ESI and the NoESI condition

  • +1 more secondary outcomes

Other Outcomes (2)

  • Effect of moderators: Sex.

    In the week preceding the start of the intervention (PRE)

  • Effect of moderators: Cognitive reserve proxies.

    In the week preceding the start of the intervention (PRE)

Study Arms (2)

Episodic Specificity Induction

EXPERIMENTAL

In each of the six training sessions, participants practice the ESI first under supervision and then unsupervised (self-administered). Self-administration is performed on a laptop. During each practice of the ESI, participants perform a detailed recall of a new 1-minute video clip of a complex scene - a skit of the famous English comedian Mr. Bean. Each session lasts for 90 minutes.

Behavioral: Episodic Specificity Induction

Associative Memory

ACTIVE COMPARATOR

In each of the six training sessions, participants recall pairs of words and pictures (e.g., names of women and rings). These pairs are presented successively after a fictitious scenario is presented to motivate memorization. There are 12 scenarios, each with 5 different word/picture pairs. Simple additions and subtractions separate the encoding phase from the recall phase. This training is adapted from Bellander et al, (2017). A general knowledge quiz is also administered at the end of the session. The training is performed on a laptop. Each session lasts for 90 minutes.

Behavioral: Associative Memory

Interventions

Recalling complex scenes using the Episodic Specificity Induction

Episodic Specificity Induction

Recalling word/picture pairs

Associative Memory

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • French-speaking
  • Right-handed
  • Sufficient visual and auditory acuity to undergo neuropsychological tests and to do the interventions.
  • Sufficient delayed recall score above the education-adjusted cut-offs (≥9 for 16+ years of education; ≥5 for 8-15 years of education; ≥3 for 0-7 years of education) at the Logical Memory test (Wechsler Memory Scale, maximum score 25).

You may not qualify if:

  • A score bellow the education-adjusted cut-offs at the MoCA ( \<24 for \>12 years of education; \<23 for = or \<12 years of education)
  • Answer 'Yes' to the two following questions: "Do you feel like your memory is becoming worse?" "Does this worry you?" (to exclude subjective cognitive decline).
  • The presence of a disease or injury of the central nervous system: moderate to severe chronic static leukoencephalopathy (including previous traumatic injury), multiple sclerosis, a serious developmental handicap, subdural hematoma (past or current), subarachnoid haemorrhage (past or current), primary cerebral tumour or cerebral metastases, epilepsy (current), dementia or another neurodegenerative disease, and other rarer brain illnesses.
  • Symptomatic stroke within the previous year.
  • Alcoholism or substance abuse
  • History of intracranial surgery.
  • Major surgery within last 2 months.
  • General anesthesia in the past 6 months.
  • Serious comorbid condition that, in the opinion of the study investigator, is likely to result in death within a year.
  • Major depression or anxiety.
  • Schizophrenia or other major psychiatric disorder (e.g., bipolar disorder).
  • Individuals where French is not sufficiently proficient for clinical assessment and neuropsychological testing.
  • Unable to undergo MRI scan due to medical contraindications or inability to tolerate the procedure.
  • Plans on moving outside the province within the next 2 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRIUGM

Montreal, Quebec, H3W 1W4, Canada

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sylvie Belleville, PhD

    Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Assessors are blind in the clinical trials. Participants know that there are different training programs but they ignore the purpose of each one.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Older participants are randomly assigned to one of two intervention conditions (Episodic Specificity Induction ; Associative Memory)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 26, 2023

First Posted

October 31, 2023

Study Start

September 22, 2023

Primary Completion

February 29, 2024

Study Completion

February 29, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
No more than one year after the end of the data collection.
Access Criteria
Public.
More information

Locations