Effectiveness of Cognitive Training in Older and Younger Adults

University of Wisconsin (UW)

Status: Enrolling

Conditions: Cognitive Change

Treatments: Behavioral: Visual and / or Auditory Cognitive Tasks (1); Behavioral: Visual and / or Auditory Cognitive Tasks (2)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06375681

1R01AG076157-01 (U.S. NIH Grant/Contract)

2019-1378: R01

A487400 (Other Identifier)

Details and patient eligibility

About

The proposed study will enroll 1600 participants to examine the effectiveness of cognitive training. Participants will be randomized into different experimental groups and can expect to participate for up to 15 hours of research over 4 to 8 weeks.

Full description

Participants will first complete two sessions (~75 minutes each) where they are asked to view visual stimuli (such as black and white lines, letters, simple shapes like triangles, circles, and squares) presented on a computer or television screen and/or listen to auditory stimuli (such as pure tones) presented via headphone or speakers. They will be asked to make some simple judgments about the stimuli (such as indicating whether the stimulus you observed is the same or different from that on a previous trial), and indicate their judgment decision with a button press on a keyboard, a mouse click, or a movement on a touchpad. They will also be asked to complete a set of questionnaires.

After the initial sessions, participants may be asked to complete two sets of 10 sessions (~20 minutes) of cognitive tasks either at home or in the lab. Each set of sessions should be completed over a period of no more than 15 days. If asked to do these sessions, instructions will be given regarding the tasks to complete in these training sessions (which will be similar to some of the tasks you complete in the first two sessions, ~20 minutes) prior to these sessions.

After completing the first set of 10 sessions, participants will complete, either at home or in the lab, one session (~75 minutes) of tasks similar to the first sessions. Participants who were not asked to complete the 20-minute sessions will complete another session two weeks after the first two 75-minute sessions in the same location as they completed the two 75-minute sessions.

Then, participants will complete the second set of ten 20-minute sessions, or wait for about two weeks for those not asked to complete the 20-minute sessions of cognitive tasks. After this, participants will complete two other sessions (~75 minutes) in the same location as they completed the previous two 75-mintue sessions.

Finally, after a couple of weeks, participants will complete their two final testing sessions (~45 minutes each) in the same location as they completed the previous two 75-mintue sessions.

The total duration of the study will be around 8 hours if not asked to complete the twenty 20-minute sessions, or 15 hours if asked to complete these sessions. The whole experiment runs over the course of 4 to 8 weeks.

*To maintain scientific integrity, certain details of this study will not be shared until all data has been collected.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Self-reported normal or corrected-to-normal vision
• No known neurological impairments

Exclusion Criteria

• Abnormal visual acuity prohibitive of training
• History of seizures, focal brain lesion, or head injury with loss of consciousness in the past year
• Physical handicap (motor or perceptual) that would impede training procedures
• Medical illness requiring treatment during the study timeline
• Social, educational or economic hardship prohibitive to training schedule
• Concurrent enrollment in other cognitive training studies
• History of major psychiatric illness, including psychosis, bipolar disorder, alcohol or substance abuse, recent bereavement
• Score of 5 or more (i.e. presence of mild, moderate, or severe depression) on the Patient Health Screening Questionnaire (PHQ-9 Depression Screening); any participants reporting suicidal tendencies will be immediately referred to the site-specific Emergency Psychiatry Services (24-hour availability), and those with high depressive symptoms will be referred to their personal physician
• Current alcohol consumption that exceeds 14 drinks per week
• Illicit drug use
• Plans to travel out of the area for more than 1 week during the intervention period
• Residence too far from the testing site, which would prevent attending the testing sessions (> 60 miles)
• Not being proficient enough in English that would prevent following and understanding all instructions and completing all testing sessions (typically, participants would need to have learned English before age 11; there might be some exceptions that will be decided on a case-by-case basis).

Additional exclusion criteria for older adults:

• Diagnosis of dementia or other neurological disease, including mild cognitive impairment (MCI)
• Score < 26 (out of 30) on the Mini Mental State Exam (MMSE)
• Score < 18 (out of 22) on the Telephone Montreal Cognitive Assessment (T-MoCA).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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1,600 participants in 2 patient groups

Short Testing Group

Active Comparator group

Description:

Participants will go through 2 assessment sessions over 2-3 days (\~75 minutes each), followed by 1 session of 75 minutes about 2 weeks later, 2 further sessions (\~75 minutes) over 2-3 days about 2 weeks after this session, and finally another 2 sessions (\~45 minutes) 3 days to 2 weeks after that session. Sessions might take place either at home or in the lab.

Treatment:

Behavioral: Visual and / or Auditory Cognitive Tasks (1)

Long Testing Group

Active Comparator group

Description:

Participants will go through 2 assessment sessions over 2-3 days (75 minutes each), followed by 10 sessions of cognitive tasks over 2 weeks, 1 session of 75 minutes about 2 weeks later, another 10 sessions of cognitive tasks over 2 weeks, then 2 sessions (\~75 minutes) over 2-3 days about 2 weeks after this session, and finally another 2 sessions (\~45 minutes) 3 days to 2 weeks after that session. Sessions might take place either at home or in the lab.

Treatment:

Behavioral: Visual and / or Auditory Cognitive Tasks (2)

Behavioral: Visual and / or Auditory Cognitive Tasks (1)