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

Working Memory Clinical Trial

— sMarT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04042779
• Other study ID #: 2018-01226; me19Magon
• Status: Completed
• Phase: N/A
• Start date: July 2, 2019
• Est. completion date: March 13, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. A sham intervention acts as active control group. Each intervention will be presented on a tablet device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Working Memory

Intervention

Other:
• model-based WM training
model-based WM training program: four sessions a week, 45 minutes each; lasting for three weeks
• single-task WM training
single-task WM training program: four sessions a week, 45 minutes each; lasting for three weeks
• multiple-task WM training
multiple-task WM training program: four sessions a week, 45 minutes each; lasting for three weeks
• sham intervention
motor training program: four sessions a week, 45 minutes each; lasting for three weeks

Locations

Country	Name	City	State
Switzerland	Department of Neurology, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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.	assessment at baseline (=T2) and 3 weeks after baseline (=T3)
Primary	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	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 12 weeks after baseline (=T4)
Secondary	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.	assessment at baseline (=T2) and 12 weeks after baseline (=T4)
Secondary	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 12 weeks after baseline (=T4)
Secondary	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	assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T4)
Secondary	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.	assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T4)
Secondary	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.	assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T
Secondary	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.	assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T
Secondary	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".	assessment at baseline (=T2) and 3 weeks after baseline (=T3) and 12 weeks after baseline (=T