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Inhibition (Psychology)NCT03532113

Attentional Control Training in Older Adults: Efficacy, Transfer and Brain Substrates

A study testing Updating, Inhibition and General knowledge in people with Inhibition (Psychology) and Updating, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Formal education and cognitively stimulating hobbies and profession have a protective effect against age-related cognitive decline and Alzheimer's disease. It is therefore possible that providing cognitively stimulating interventions at a later age increases neuroplasticity and brain resilience. Read more about this study

Who is it for?
Ages 60 to 85 yearsHealthy volunteers can take part
What is being tested?
Updating, Inhibition and General knowledge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteCanada
Study dates
19 Oct 2017to 20 Dec 2019
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 60 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • CRIUGM

    Montreal, Quebec, H3W 1W4

Other trials in Canada

About this study

Official title: Memory and Cognitive Control for Optimal Aging: Study on the Effect of Cognitive Interventions, Cerebral Mechanisms Involved and Processes Promoting Transfer

Formal education and cognitively stimulating hobbies and profession have a protective effect against age-related cognitive decline and Alzheimer's disease. It is therefore possible that providing cognitively stimulating interventions at a later age increases neuroplasticity and brain resilience. Processes of updating and inhibition are both impaired by aging. Several studies have shown that updating can be improved but very few studies targeted inhibition in spite of the fact that it is impaired in older adults. The aim of this study is to assess the effect of cognitive interventions that will target either of these two components. The investigators will examine the effect on behavior, brain measures and transfer tasks. The investigators will also assess whether the efficacy varies as a function of personal variables such as prior cognitive profile, reserve proxies, genetic polymorphisms and brain markers.

Read the detailed description

Formal education and cognitively stimulating hobbies and profession have a protective effect against age-related cognitive decline and Alzheimer's disease. The cognitive reserve model suggests that engaging in cognitively stimulating activities may induce brain processes and/or morphological characteristics that make individuals more resilient to the effects of brain damage. It is therefore possible that providing cognitive interventions at a later age amplify similar neuroplastic processes and thus reduce the deleterious effects of aging. Cognitive interventions refer to programs and/or strategies aimed at increasing or optimizing cognitive performance. Many of these programs target working memory (WM), which is defined as the ability to control attention in order to keep information active and accessible. Miyake's influential model proposes that WM relies on the coordinated functioning of a small set of attentional control components. Here the investigators will focus on two of these components: inhibition and updating. Training those two components might reveal critical as they are impaired in aging and subtend a range of more complex cognitive processes. Furthermore, they rely on distinct brain networks and are sensitive to cognitive lifestyle. Several studies have shown that updating capacities of older adults can be improved by cognitive training but very few studies targeted inhibition in spite of the fact that it is severly impaired by aging. The aim of this study is to assess the effect of cognitive interventions that will target either of these two components and compare their effect to that of an active control training. The investigators will examine their effect on behavior, brain measures and transfer tasks. The investigators will also assess whether the efficacy varies as a function of personal variables such as prior cognitive profile, reserve proxies, genetic polymorphisms and brain markers. The investigators will also examine the cumulative effect of training by measuring efficacy at three time points for the proximal outcomes and at five time points for the distal outcomes. Finally, a group of younger adults will be tested at baseline to assess whether training normalize performance, that is, whether the performance of older adults after training is improved to the level of typical young adults.

90 healthy older adults (60-85 years) will be recruited for this study, as well as thirty young adults (20-35 years) who will complete only the initial assessment (PRE). All participants will be recruited from the community and living in the Montreal area. A telephone interview will provide initial selection information. Eligible persons will be invited to come to the laboratory for a standardized clinical and neuropsychological battery in order to evaluate their clinical status and cognitive functioning. The older adults will be randomly assigned to one of three intervention conditions (Inhibition, Updating, Active control). Updating will be trained using N-back-like exercises whereas inhibition will be trained with Stroop-like exercises. Different types of stimuli will be used to facilitate transfer. The control intervention will include exercises on general knowledge and vocabulary. All training will be computerized. Training will be provided in 12 half-hours training sessions. Outcome measures will be taken no more than two weeks prior to training (PRE), between Session 6 and 7 (POST1) and no more than one week following Session 12 (POST2). Participants will be trained in small groups of 6 to 10 individuals recruited in about 6 waves. The first two waves will allow to pilot the procedure/team and will be accrued to the whole trial if the training procedure and outcome measures remain unchanged.

Being tested
Updating, Inhibition, General knowledge
Keywords
Cognitive intervention, Cognitive training, Aging, Working memory, Cognitive reserve, Brain imaging, Brain plasticity, Polymorphisms, Transfer, Inhibition, Updating
Medical subject headings
Inhibition, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UpdatingBehavioural

    Updating is trained across 12 sessions using N-back-type exercises. Training is performed on a samsung galaxy tab2. Each session lasts 30 minutes. The difficult is reset and the nature of the stimuli (numbers vs. symbols) is changed halfway in each session.

  • InhibitionBehavioural

    Inhibition is trained across 12 sessions with Stroop-like exercises. Training is performed on a samsung galaxy tab2. Each session lasts 30 minutes. The difficult is reset and the nature of stimuli (letters vs. numbers) is changed halfway in each session.

  • General knowledgeBehavioural

    General Knowledge is trained across 12 sessions. Participants complete four-choice questions relating to general knowledge and vocabulary and are provided with the correct answer and a short explanation. Questions are displayed one by one on a computer screen with a maximum of 20 seconds per question. Each session lasts 30 minutes and includes 2 blocks of 40 new questions each (about 220 seconds per block). Questions with wrong answers are displayed again at the end of each block.

Study groups in NCT03532113
Study groupRoleWhat they receive
UpdatingExperimentalThe Updating intervention aims to improve the ability to monitor and quickly add or delete of content of working memory.
Receives: Behavioral: Updating
InhibitionExperimentalThe Inhibition intervention aims to improve the ability to supersede responses that are prepotent or automatic for a given situation.
Receives: Behavioral: Inhibition
General KnowledgeActive comparatorThe General knowledge intervention allows the learning of information on various topics. It does not involve attentional control but semantic knowledge.
Receives: Behavioral: General knowledge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes on the updating composite measure (Proximal outcome).

    An updating composite score will be computed by averaging z-scores from the Keep track task and the Running span task.

    Measured: within the 2 weeks before intervention starts; 3rd week after intervention starts (after the 6th training session); 6th week (after the 12th training session)

  2. Changes on the inhibition composite measure (Proximal outcome).

    An inhibition composite score will be computed by averaging z-scores from the Anti-saccade and the Victoria Stroop Test.

    Measured: within the 2 weeks before intervention starts; 3rd week after intervention starts (after the 6th training session); 6th week (after the 12th training session)

Secondary outcomes (7)
  1. Transfer to complex working memory measure: the Alpha-span task (Distal outcome).

    Accuracy on the alphabetic portion of the Alpha-span task

    Measured: within the 2 weeks before intervention starts; 1st week after intervention starts (after the 3rd training session); 3rd week (after the 6th training session); 4th week (after the 9th training session); 6th week (after the 12th training session).

  2. Transfer to complex working memory measure: the Reading span task (Distal outcome).

    Accuracy on the Reading span task.

    Measured: within the 2 weeks before intervention starts; 1st week after intervention starts (after the 3rd training session); 3rd week (after the 6th training session); 4th week (after the 9th training session); 6th week (after the 12th training session).

  3. Transfer to complex working memory measure: the virtual car ride task (Distal outcome).

    Average z-score computed with the verbal and visual (accuracy and RT) components of the divided attention virtual reality task.

    Measured: within the 2 weeks before intervention starts; 1st week after intervention starts (after the 3rd training session); 3rd week (after the 6th training session); 4th week (after the 9th training session); 6th week (after the 12th training session).

  4. Brain structure: Regional gray matter volumes in Prefrontal and lateral temporal cortices, Basal ganglia and Hippocampi.

    A T1-weighted 3D-MPRAGE sequence (TR/TE 2300/2.98ms, Fa 9°, FOV = 256*256, matrix 256*256, voxels 1mm³, 192 slices) will be used to measure regional gray matter volume.

    Measured: within the 2 weeks before intervention starts; 3rd week after intervention starts (after the 6th training session); 6th week (after the 12th training session)

  5. Brain structure: Cortical thickness in Prefrontal regions and lateral temporal cortices.

    A T1-weighted 3D-MPRAGE sequence (TR/TE 2300/2.98ms, Fa 9°, FOV = 256*256, matrix 256*256, voxels 1mm³, 192 slices) will be used to measure cortical thickness (FreeSurfer 5.3).

    Measured: within the 2 weeks before intervention starts; 3rd week after intervention starts (after the 6th training session); 6th week (after the 12th training session)

  6. Brain function: Updating related activation.

    Functional activations. Simultaneous multislice (accelerator factor = 6), echo polar (EPI) imaging: TR/TE 785/30 ms, Fa 54°, FOV 192*192, matrix 64*64, voxels 3 mm³, 39 slices) will be measured in association with a N-back task.

    Measured: within the 2 weeks before intervention starts; 3rd week after intervention starts (after the 6th training session); 6th week (after the 12th training session)

  7. Brain function: Inhibition related activation.

    Functional activations. Simultaneous multislice (accelerator factor = 6), echo polar (EPI) imaging: TR/TE 785/30 ms, Fa 54°, FOV 192*192, matrix 64*64, voxels 3 mm³, 39 slices) will be measured in association with a counting stroop.

    Measured: within the 2 weeks before intervention starts; 3rd week after intervention starts (after the 6th training session); 6th week (after the 12th training session)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2018
  2. Study start19 Oct 2017
  3. Primary completion20 Dec 2019
  4. Study completion20 Dec 2019

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Older participants are randomly assigned to one of three intervention conditions (Inhibition ; Updating ; General knowledge). Young participants only complete the initial assessment.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03532113
Sponsor's protocol ID
CRIUGM-005
Status last verified
Jan 2020
First submitted
18 Apr 2018
Last updated
23 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Verty LV, Mellah S, Maltezos S, Boujut A, Lussier M, Bherer L, Belleville S. Youth-like brain activation linked with greater cognitive training gains in older adults: Insights from the ACTOP study. Cortex. 2024 Jul;176:221-233. doi: 10.1016/j.cortex.2024.04.013. Epub 2024 May 17.

    PubMed 38805784
  • Boujut A, Verty LV, Maltezos S, Lussier M, Mellah S, Bherer L, Belleville S. Effects of Computerized Updating and Inhibition Training in Older Adults: The ACTOP Three-Arm Randomized Double-Blind Controlled Trial. Front Neurol. 2020 Dec 3;11:606873. doi: 10.3389/fneur.2020.606873. eCollection 2020.

    PubMed 33343503
  • Boujut A, Mellah S, Lussier M, Maltezos S, Verty LV, Bherer L, Belleville S. Assessing the Effect of Training on the Cognition and Brain of Older Adults: Protocol for a Three-Arm Randomized Double-Blind Controlled Trial (ACTOP). JMIR Res Protoc. 2020 Nov 24;9(11):e20430. doi: 10.2196/20430.

    PubMed 33231556

Questions about this trial

What is this clinical trial studying?

A study testing Updating, Inhibition and General knowledge in people with Inhibition (Psychology) and Updating, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 1 site in Canada.

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 4 inclusion and 13 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 23 Jan 2020. 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 Canada. 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?

Changes on the updating composite measure (Proximal outcome). (time frame: within the 2 weeks before intervention starts; 3rd week after intervention starts (after the 6th training session); 6th week (after the 12th training session)). The study lists 2 primary outcomes in all. 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 NCT03532113, 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 23 Jan 2020.

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