NCT06235840

Brief Summary

There are two important aspects in which the present project will allow to enrich our understanding of compensatory brain activity in older adults. First, in the studies that have been conducted so far the compensatory brain activity in older adults was investigated primarily with the use of the functional magnetic resonance (fMRI) or positon emission tomography (PET). In order to identify compensatory activity in our study we will use electroencephalographic markers (observable in EEG). It will allow to confirm the assumptions about compensatory brain activity relying on new data, as in EEG research the brain markers of the same cognitive processes are different from those used in fMRI and PET research. What is more, in the studies conducted so far brain activity in older adults was only registered and interpreted, whereas the present study additionally adds the training component. The aim of our study is to see if it is possible to influence the compensatory brain activity through cognitive functions training, relying on working memory training. Theoretically, such a training should optimize brain activity in older adults, namely evoke compensatory brain activity during difficult tasks in order to make them easier, whereas in the case of easy tasks it should lead to the disappearance of the need to trigger compensatory activity. This assumption will be verified in an experimental setting. The participants will be divided into six groups: two experimental (the groups of young and old adults), and by analogy two active control groups and two passive (no-contact) control groups. The experiment was designed in the following way: (1) All groups will be subjected to pre-test measurements that will be EEG registration during a cognitive task execution at different difficulty levels; (2) Experimental groups will undergo working memory training. Over the period of 4 weeks participants in the experimental groups will take part in 12 training sessions. In the active control groups instead of the n-back training the practice of tasks which do not involve working memory will be introduced. Participants of the passive control groups will be awaiting post-test (no-contact control); (3) In all groups post-test measurements will be administered analogically to the pre-test measurements in order to assess changes in cognitive tasks performance and related brain activity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

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

November 29, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

4.2 years

First QC Date

September 10, 2020

Last Update Submit

January 23, 2024

Conditions

Keywords

cognitive interventioncognitive trainingcognitive agingneuroplasticitycompensatory brain activityeeg

Outcome Measures

Primary Outcomes (7)

  • Change EEG power in theta, alpha and gamma bands (n-back task)

    The neural brain activity accompanying cognitive engagement during the n-back task execution. EEG data will be obtained from 32 Ag/AgCl electrodes (left: Fp1, AF3, F3, F7, FC1, FC5, C3, CP1, CP5, F7, P3, P7, PO3, O1; right: Fp2, AF4, F4, F8, FC2, FC6, C4, CP2, CP6, F8, P4, P8, PO4, O2; midline: Fz, Cz, Pz, Oz) placed in accordance with the 10-20 international system and referenced to the right and left earlobes.

    change from baseline at 4 weeks

  • Change n-back task

    Accuracy and reaction times in the n-back task indicated by the senstitivity index

    change from baseline at 4 weeks

  • Change in EEG power in theta, alpha and gamma bands (GoNoGo task)

    The neural brain activity accompanying cognitive engagement during the GoNoGo task execution. EEG data will be obtained from 32 Ag/AgCl electrodes (left: Fp1, AF3, F3, F7, FC1, FC5, C3, CP1, CP5, F7, P3, P7, PO3, O1; right: Fp2, AF4, F4, F8, FC2, FC6, C4, CP2, CP6, F8, P4, P8, PO4, O2; midline: Fz, Cz, Pz, Oz) placed in accordance with the 10-20 international system and referenced to the right and left earlobes.

    change from baseline at 4 weeks

  • Change in GoNoGo task

    Accuracy and reaction times in the GoNoGo task.

    change from baseline at 4 weeks

  • Change in EEG power in theta, alpha and gamma bands (Stroop task)

    The neural brain activity accompanying cognitive engagement during the Stroop task execution. EEG data will be obtained from 32 Ag/AgCl electrodes (left: Fp1, AF3, F3, F7, FC1, FC5, C3, CP1, CP5, F7, P3, P7, PO3, O1; right: Fp2, AF4, F4, F8, FC2, FC6, C4, CP2, CP6, F8, P4, P8, PO4, O2; midline: Fz, Cz, Pz, Oz) placed in accordance with the 10-20 international system and referenced to the right and left earlobes.

    change from baseline at 4 weeks

  • Change in Stroop task

    Accuracy and reaction times in the Stroop task

    change from baseline at 4 weeks

  • Change in OSpan task

    Accuracy in the OSpan task

    change from baseline at 4 weeks

Secondary Outcomes (3)

  • Change in Digit Span

    change from baseline at 4 weeks

  • Change in Digit-Symbol

    change from baseline at 4 weeks

  • Change in Raven's SPM

    change from baseline at 4 weeks

Other Outcomes (4)

  • M.I.N.I. Screen 7.0.2

    On the first day of participation in the study, successively for the following participants over 3 years

  • Structured interview

    On the first day of participation in the study, successively for the following participants over 3 years

  • MMSE

    On the 1st day of participation in the study of each older adult, successively for the following participants over 3 years

  • +1 more other outcomes

Study Arms (3)

Working memory adaptive cognitive training

EXPERIMENTAL

In the intervention, the n-back task involving working memory in terms of its content updating was applied. This task is based on the continuous presentation of items (letters in this study) that appear and disappear one by one. During each presentation, the participant must judge whether the currently displayed item matches the item presented 'n' trials earlier. The n-back task used in the current study was computerized and was programmed in PsychoPy software. All participants started their training from the 1-back level. The training was adaptive, meaning that, according to the performance accuracy achieved, participants progressed to higher (or dropped to lower) levels of difficulty. The increasing/decreasing difficulty was based on a rise/fall in the 'n' parameter. Participants were involved in 12 sessions, three in each of the four weeks. Each session lasted approximately 45 minutes.

Behavioral: working memory adaptive training

Multi-domain non-adaptive cognitive training

ACTIVE COMPARATOR

Non-adaptive multi-domain computerized training included tasks involving: visual-spatial functions, visual and verbal memory, reasoning on visual and verbal material, and calculia. Participants were involved in 12 sessions, three in each of the four weeks. Each session lasted approximately 45 minutes.

Behavioral: multi-domain non-adaptive control training

No contact

NO INTERVENTION

The passive control group was the no-contact group. Participants had no contact with the researcher for 4 weeks, corresponding to the duration of the intervention (training) in the experimental group.

Interventions

The computerized n-back training lasted 4 weeks and consisted of 12 training sessions, 3 per week, about 45 minutes for each

Working memory adaptive cognitive training

The cognitive training in active control groups included cognitive tasks involving: visual-spatial functions, visual and verbal memory, reasoning on visual and verbal material, and calculia. The training schedule in active control groups was the same as in the experimental groups.

Multi-domain non-adaptive cognitive training

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: belonging to one of the age groups - older adults (60-75 years old) or young adults (20-35 years old). The 60-75 age group limits the influence of the advance of various age-related changes, and at the same time, this group is classified as early late-adulthood. The 20-35 group, on the other hand, falls within early adulthood (Sugarman, 2001);
  • No history of mental illness;
  • No history of neurological disorders, including neurodegenerative diseases, or severe head injuries.
  • Normal or corrected-to-normal vision;
  • Intellectual norm;
  • No dementia symptoms (in old adults);
  • No visible abnormal brain activity in EEG (verifiable only in the pre-test);
  • Signing an informed consent to participate in the study (after familiarizing oneself with the aim of the study and the conditions of participation, as well as having received satisfactory answers to all questions).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kazimierz Wielki University, Faculty of Psychology

Bydgoszcz, Polska, 85-867, Poland

Location

Related Publications (1)

  • Zajac-Lamparska L. Limited training and transfer effects in older and young adults who participated in 12 sessions of process-based working memory training. A three-armed pretest-posttest design study. BMC Res Notes. 2024 Jun 28;17(1):181. doi: 10.1186/s13104-024-06844-2.

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Ludmiła Zając-Lamparska, Professor

    Kazimierz Wielki University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A pretest-posttest study design with one experimental group and two control (passive and active control) groups was applied.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 10, 2020

First Posted

February 1, 2024

Study Start

November 29, 2018

Primary Completion

January 24, 2023

Study Completion

January 24, 2024

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations