NCT04042779

Brief Summary

This study is to investigate the efficacy of model-based Working Memory (WM) training using an appropriate control condition. The interventions are a model-based, a single-task and a multiple-task training on WM in order to compare the efficacies of these different training approaches for WM. A sham intervention acts as active control group. Each intervention will be presented on a tablet device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

July 31, 2019

Last Update Submit

June 30, 2020

Conditions

Keywords

Multiple task trainingSingle task trainingModel-based working memory trainingCognitive trainingLong-term WM capacitynear transfer effects of the trainingfar transfer effects of the training

Outcome Measures

Primary Outcomes (3)

  • Change in Rotation Span Task Score

    First, the distractor task is judging whether a rotated letter is presented correctly, or is a mirrored image of the letter. Second, the to-be-remembered items are arrows of either short or long length and pointing in one of eight different directions. Finally, the rotation-arrow sequence is repeated from two to five times per trial. Scores are calculated by summing the number of arrows correctly recalled in the correct order.

    assessment at baseline (=T2) and 3 weeks after baseline (=T3)

  • Change in Symmetry Span Task Score

    First, the distractor task is judging whether a displayed shape is symmetrical along its vertical axis. Second, the to-be-remembered items are locations of red squares in a 4Ă—4 grid of potential locations. Finally, the number of symmetry-location pairs varied from two to five times per trial. Scores are calculated by summing the number of red square locations correctly recalled in the correct order.

    assessment at baseline (=T2) and 3 weeks after baseline (=T3)

  • Change in Operation Span Task Score

    Subjects first solve a math problem, and then see a letter, and then solve another math problem, and see another letter. This math-letter sequence is repeated from three to seven times for each trial with an unpredictable length each time. After each math-letter sequence, subjects are asked to recall, in order, the preceding letters. Scores are calculated by summing the number of letters correctly recalled in the correct order.

    assessment at baseline (=T2) and 3 weeks after baseline (=T3)

Secondary Outcomes (8)

  • Change in Rotation Span Task Score

    assessment at baseline (=T2) and 12 weeks after baseline (=T4)

  • Change in Symmetry Span Task Score

    assessment at baseline (=T2) and 12 weeks after baseline (=T4)

  • Change in Operation Span Task Score

    assessment at baseline (=T2) and 12 weeks after baseline (=T4)

  • Change in Trail making Test A/B

    assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T4)

  • Change in Rey Auditory Verbal Learning test

    assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T4)

  • +3 more secondary outcomes

Study Arms (4)

model-based WM training

ACTIVE COMPARATOR

In order to build the model-based WM training, existing tasks used to assess the different component of the Baddeley's model will be reviewed on their findings according to test-retest reliability and construct validity. For each component - phonological loop, visuospatial sketchpad, episodic buffer and central executive - the task with the highest reliability and validity will be chosen and then build the basis for the computerized training program. This procedure results in a model-based, adaptive, computerized training program for WM.

Other: model-based WM training

single-task WM training

ACTIVE COMPARATOR

The basis for the single-task training administered to the second group will be the widely used "dual-n-back training paradigm" suggested by Jaeggi et al. (2008). A complex dual n-back task including a visual and an auditory WM task will be implemented for tablet devices.

Other: single-task WM training

multiple-task WM training

ACTIVE COMPARATOR

Verbal WM tasks - particularly letter span and digit span tasks - and a visuospatial WM task are most commonly used (e.g. Dahlin et al., 2008; Klingberg et al., 2005; Westerberg et al., 2007). Therefore, a multiple-task training including these tasks will be administered to the third group.

Other: multiple-task WM training

sham intervention

SHAM COMPARATOR

Active control group that as well performs a training, however not based on WM. To exclude the involvement of WM, a motor training will be administered to the control group.

Other: sham intervention

Interventions

model-based WM training program: four sessions a week, 45 minutes each; lasting for three weeks

model-based WM training

single-task WM training program: four sessions a week, 45 minutes each; lasting for three weeks

single-task WM training

multiple-task WM training program: four sessions a week, 45 minutes each; lasting for three weeks

multiple-task WM training

motor training program: four sessions a week, 45 minutes each; lasting for three weeks

sham intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent as documented by signature

You may not qualify if:

  • Medical history of neurological or psychiatric disorders
  • Any history of substance abuse
  • Color vision deficiency
  • Inability to used table devices
  • Montreal Cognitive Assessment \< 26

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, University Hospital Basel

Basel, 4031, Switzerland

Location

Study Officials

  • Stefano Magon, Dr. phil.

    Department of Neurology, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

July 2, 2019

Primary Completion

March 13, 2020

Study Completion

March 13, 2020

Last Updated

July 1, 2020

Record last verified: 2020-06

Locations