Working MemorysMarTNCT04042779
Development of a Model-based Working Memory Training and Investigation of Its Comparative Efficacy
A study testing model-based WM training, single-task WM training and multiple-task WM training in people with Working Memory, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Working Memory
- What is being tested?
- model-based WM training, single-task WM training and multiple-task WM training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jul 2019to 13 Mar 2020
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent as documented by signature
Who cannot join
- Medical history of neurological or psychiatric disorders
- Any history of substance abuse
- Color vision deficiency
- Inability to used table devices
- Montreal Cognitive Assessment < 26
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurology, University Hospital Basel
Basel, 4031
About this study
Official title: Development of a Model-based Working Memory Training and Investigation of Its Comparative Efficacy: A Randomized, Double-blind Study on Healthy Adults
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.
- Conditions
- Working Memory
- Being tested
- model-based WM training, single-task WM training, multiple-task WM training, sham intervention
- Keywords
- Multiple task training, Single task training, Model-based working memory training, Cognitive training, Long-term WM capacity, near transfer effects of the training, far transfer effects of the training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
model-based WM trainingOther
model-based WM training program: four sessions a week, 45 minutes each; lasting for three weeks
single-task WM trainingOther
single-task WM training program: four sessions a week, 45 minutes each; lasting for three weeks
multiple-task WM trainingOther
multiple-task WM training program: four sessions a week, 45 minutes each; lasting for three weeks
sham interventionOther
motor training program: four sessions a week, 45 minutes each; lasting for three weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 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.
Measured: 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.
Measured: assessment at baseline (=T2) and 3 weeks after baseline (=T3)
Secondary outcomes (8)
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.
Measured: assessment at baseline (=T2) and 12 weeks after baseline (=T4)
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 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.
Measured: assessment at baseline (=T2) and 12 weeks after baseline (=T4)
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.
Measured: assessment at baseline (=T2) and 12 weeks after baseline (=T4)
Change in Trail making Test A/B
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
Measured: assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T4)
Change in Rey Auditory Verbal Learning test
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.
Measured: assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T4)
Change in Rey Osterrieth Complex Figure Test
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.
Measured: assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T
Change in Raven's Progressive Matrices
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.
Measured: assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T
Change in Depression Anxiety Stress Scales
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".
Measured: assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start2 Jul 2019
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Working MemoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Magon, Dr. phil., Principal investigator, Department of Neurology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042779
- Sponsor's protocol ID
- 2018-01226; me19Magon
- Other IDs
- 2018
- Acronym
- sMarT
- Status last verified
- Jun 2020
- First submitted
- 31 Jul 2019
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Model-based Working Memory Training and Investigation of Its Comparative Efficacy: A Randomized, Double-blind Study on Healthy Adults
- ClinicalTrials.gov ID
- NCT04042779
- Acronym / sponsor ID
- sMarT / 2018-01226; me19Magon
- Conditions
- Working Memory
- Keywords
- Multiple task training, Single task training, Model-based working memory training, Cognitive training, Long-term WM capacity, near transfer effects of the training, far transfer effects of the training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| model-based WM training | Active comparator | Other: model-based WM trainingIn 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 comparator | Other: single-task WM trainingThe 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 comparator | Other: multiple-task WM trainingVerbal 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 comparator | Other: sham interventionActive 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Informed consent as documented by signature
Key exclusion criteria (5 listed)
- Medical history of neurological or psychiatric disorders
- Any history of substance abuse
- Color vision deficiency
- Inability to used table devices
- Montreal Cognitive Assessment < 26
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| model-based WM trainingmodel-based WM training program: four sessions a week, 45 minutes each; lasting for three weeks | Other | model-based WM training |
| single-task WM trainingsingle-task WM training program: four sessions a week, 45 minutes each; lasting for three weeks | Other | single-task WM training |
| multiple-task WM trainingmultiple-task WM training program: four sessions a week, 45 minutes each; lasting for three weeks | Other | multiple-task WM training |
| sham interventionmotor training program: four sessions a week, 45 minutes each; lasting for three weeks | Other | sham intervention |
Primary outcome
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.
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.
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.
8 secondary outcomes
Change in Rotation Span Task Score
Time frame: assessment at baseline (=T2) and 12 weeks after baseline (=T4)
Change in Symmetry Span Task Score
Time frame: assessment at baseline (=T2) and 12 weeks after baseline (=T4)
Change in Operation Span Task Score
Time frame: assessment at baseline (=T2) and 12 weeks after baseline (=T4)
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)
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)
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
Change in Raven's Progressive Matrices
Time frame: assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T
Change in Depression Anxiety Stress Scales
Time frame: assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Magon, Dr. phil. principal investigator
Department of Neurology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing model-based WM training, single-task WM training and multiple-task WM training in people with Working Memory, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 1 inclusion and 5 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 1 Jul 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
Change in Rotation Span Task Score (time frame: assessment at baseline (=T2) and 3 weeks after baseline (=T3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2020.