Development of a Model-based Working Memory Training and Investigation of Its Comparative Efficacy
sMarT
1 other identifier
interventional
131
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
July 31, 2019
CompletedFirst Posted
Study publicly available on registry
August 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2020
CompletedJuly 1, 2020
June 1, 2020
9 months
July 31, 2019
June 30, 2020
Conditions
Keywords
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 COMPARATORIn 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.
single-task WM training
ACTIVE COMPARATORThe 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.
multiple-task WM training
ACTIVE COMPARATORVerbal 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.
sham intervention
SHAM COMPARATORActive 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.
Interventions
model-based WM training program: four sessions a week, 45 minutes each; lasting for three weeks
single-task WM training program: four sessions a week, 45 minutes each; lasting for three weeks
multiple-task WM training program: four sessions a week, 45 minutes each; lasting for three weeks
motor training program: four sessions a week, 45 minutes each; lasting for three weeks
Eligibility Criteria
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
Study Officials
- PRINCIPAL INVESTIGATOR
Stefano Magon, Dr. phil.
Department of Neurology, University Hospital Basel
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