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Completed

NCT Number: NCT04042779

Development of a Model-based Working Memory Training and Investigation of Its Comparative Efficacy

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.

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Key information

Conditions

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent as documented by signature

Exclusion criteria

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

Treatment and study plan

model-based WM training

Other

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

single-task WM training

Other

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

multiple-task WM training

Other

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

Sham intervention

Other

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

Primary outcomes

  1. Change in Rotation Span Task Score

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

    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.

  2. Change in Symmetry Span Task Score

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

    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 4×4 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.

  3. Change in Operation Span Task Score

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

    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.

Secondary outcomes

  1. Change in Rotation Span Task Score

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

    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.

  2. Change in Symmetry Span Task Score

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

    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 4×4 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.

  3. Change in Operation Span Task Score

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

    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.

  4. Change in Trail making Test A/B

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

    The Trail making Test A/B consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy with the time taken to complete the test being used as the primary performance metric

  5. Change in Rey Auditory Verbal Learning test

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

    Participants are read a list of 15 words aloud by the person administering the test. The entire test takes 10-15 minutes to administer and includes five presentations of a 15 word list (list A), followed by a free recall of a second word list (list B). Finally there is a sixth recall trial of the first list (List A). Recognition is tested by asking which of 30 words wre read aloud from list A and which were not. The words are read at a rate of one word per second. The overall goal of the task is to repeat all of the words the participant can remember in any order.

  6. Change in Rey Osterrieth Complex Figure Test

    Time frame: assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T

    The Rey-Osterrieth complex figure test (ROCF) is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall). Each copy is scored for the accurate reproduction and placement of 18 specific design elements.

  7. Change in Raven's Progressive Matrices

    Time frame: assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T

    The Raven's Progressive Matrices is administered as a nonverbal group test. It is typically a 60-item test used in measuring abstract reasoning and regarded as a non-verbal estimate of fluid intelligence. Many patterns are presented in the form of a 6×6, 4×4, 3×3, or 2×2 matrix, giving the test its name. All of the questions on the Raven's progressives consist of visual geometric design with a missing piece. The test taker is given six to eight choices to pick from before filling in the missing piece. Scoring on the Raven's Progressive Matrices is based on two factors: How many out of 60 matrices problems the tester correctly solved and the age of the tester. For each age group, N number of correct answers corresponds to a certain percentile score.

  8. Change in Depression Anxiety Stress Scales

    Time frame: assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T

    The Depression Anxiety Stress Scales is made up of 42 self-report items to be completed over five to ten minutes, each reflecting a negative emotional symptom. Each of these is rated on a four-point Likert scale of frequency or severity of the participants' experiences over the last week with the intention of emphasising states over traits. These scores ranged from 0, meaning that the client believed the item "did not apply to them at all", to 3 meaning that the client considered the item to "apply to them very much, or most of the time".

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Development of a Model-based Working Memory Training and Investigation of Its Comparative Efficacy: A Randomized, Double-blind Study on Healthy Adults

Acronym: sMarT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 2, 2019
Registry last updated
Jul 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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