Cognitive Training for Cognitive Impairment

Recruiting at 2 trial locations

Overseen By C. Shawn Green, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Seizures, Brain lesion, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 25

1600 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those with medical illnesses requiring treatment during the study. It's best to discuss your specific situation with the trial coordinators.

What data supports the effectiveness of the treatment Visual and / or Auditory Cognitive Tasks, Cognitive Training Exercises, Working Memory Tasks, Attention and Processing Speed Training, Visual and Auditory Cognitive Exercises for cognitive impairment?

Research shows that cognitive training, including computer-based exercises, can improve memory and attention in people with cognitive impairments, such as those with brain injuries or early-stage Alzheimer's disease. Studies have found that these exercises can lead to better cognitive performance and mood, suggesting they may help slow cognitive decline. ^{1 2 3 4 5}

Is cognitive training safe for humans?

The research does not report any safety concerns related to cognitive training exercises, suggesting they are generally safe for humans. ^{6 7 8 9 10}

How is the treatment 'Visual and/or Auditory Cognitive Tasks' different from other treatments for cognitive impairment?

This treatment is unique because it focuses on engaging both visual and auditory senses through cognitive exercises, which may be particularly beneficial for older adults with hearing and vision impairments, a group often at high risk for cognitive decline. Unlike some other cognitive training methods, this approach can be tailored to include these sensory components, potentially making it more inclusive and effective for a broader population. ^{1 2 6 11 12}

Research Team

Aaron R. Seitz, PhD

Principal Investigator

University of California, Riverside

Susanne M. Jaeggi, PhD

Principal Investigator

Northeastern University

Eligibility Criteria

This trial is for individuals experiencing cognitive impairment. It's designed to include a wide age range, so both older and younger adults can participate. The main requirement is the ability to perform visual and/or auditory tasks.

Inclusion Criteria

Self-reported normal or corrected-to-normal vision

No known neurological impairments

Exclusion Criteria

Social, educational or economic hardship prohibitive to training schedule

Score of 5 or more on the Patient Health Screening Questionnaire (PHQ-9 Depression Screening); participants reporting suicidal tendencies will be immediately referred to Emergency Psychiatry Services, and those with high depressive symptoms will be referred to their personal physician

Current alcohol consumption that exceeds 14 drinks per week

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

Initial Assessment

Participants complete two sessions of visual and auditory stimuli tasks and questionnaires

2-3 days

2 visits (in-person)

Cognitive Training

Participants may complete two sets of 10 sessions of cognitive tasks either at home or in the lab

4 weeks

20 sessions (in-person or virtual)

Midpoint Assessment

Participants return to the lab for a session of tasks similar to the initial assessment

1 day

1 visit (in-person)

Final Assessment

Participants complete two final testing sessions

2-3 days

2 visits (in-person)

Follow-up

Participants are monitored for changes in cognitive performance and other measures

up to 60 days

Treatment Details

Interventions

• Visual and / or Auditory Cognitive Tasks (1)
• Visual and / or Auditory Cognitive Tasks (2)

Trial Overview The study tests how effective different types of cognitive training are on improving mental functions. Participants will be randomly assigned to groups that receive either one or two types of visual/auditory tasks over a period of 4-8 weeks.

Participant Groups

Group I: Long Testing Group Active Control 2 Interventions

Participants will go through 2 assessment sessions over 2-3 days (75 minutes each), followed by 10 sessions of cognitive tasks over 2 weeks in-lab or at-home, 1 session of 75 minutes about 2 weeks later, another 10 sessions of cognitive tasks over 2 weeks in-lab or at-home, then 2 sessions (\~45 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. Unless otherwise specified, all the sessions will take place in the lab.

Group II: Short Testing Group Active Control 1 Intervention

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 (\~45 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. All the sessions will take place in the lab.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

Cognitive training using serious games showed positive interactions and outcomes for patients with cognitive impairment in a pilot study involving 14 participants, indicating potential benefits for cognition and mood.

However, participant retention was a challenge, with only half continuing after five weeks due to factors like patient turnover and difficulties in integrating the training into daily routines, highlighting the importance of facilitator support and individualized program adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[User friendliness of computer-based cognitive training for psychogeriatric patients with mild to moderate cognitive impairments]. van der Ploeg, ES., Hoorweg, A., van der Lee, J.[2016]

A study involving 40 participants with early-stage Alzheimer's disease found that a 12-week paper-based cognitive training program significantly improved overall cognitive function, as measured by the Mini-Mental State Examination.

The intervention group showed notable enhancements in specific cognitive areas, including language, attention, and executive function, compared to the control group, suggesting that structured cognitive training can be beneficial for individuals in the early stages of Alzheimer's.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Paper-Based Cognitive Training in Early Stage of Alzheimer's Dementia. Kang, MJ., Kim, SM., Han, SE., et al.[2022]

A computerized attention training program was implemented for a 98-year-old woman with dementia and visual impairment, consisting of 8 sessions over several weeks, which showed promising results.

The training led to improvements in attention and processing speed, as measured by the Test of Attentional Performance (TAP), suggesting that such interventions could benefit visually impaired older adults with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized attention training for visually impaired older adults with dementia: a case study. Kuo, MCC., Fong, TY., Fung, CW., et al.[2020]

The RehaCom computerized cognitive training program significantly improved attention and memory functions in 50 brain injury patients after 60 training sessions, with all patients showing enhanced performance in the targeted areas.

The program was well-tolerated, with no reported negative effects such as mental fatigue, headache, or eye irritation, indicating its safety for use in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. Fernández, E., Bringas, ML., Salazar, S., et al.[2022]

The MEMO+ study is a randomized controlled trial involving 162 participants with mild cognitive impairment (MCI) to evaluate the efficacy of cognitive training and psychosocial interventions over an eight-week period.

The study aims to measure both immediate and long-term effects on cognitive function and daily living skills, potentially leading to improved well-being for individuals with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the impact of cognitive and psychosocial interventions in persons with mild cognitive impairment with a randomized single-blind controlled trial: rationale and design of the MEMO+ study. Bier, N., Grenier, S., Brodeur, C., et al.[2022]

The SmartTapestry device, tested on 53 participants (29 healthy and 24 with mild cognitive impairment), effectively combines physical activity with cognitive training, showing a strong correlation with traditional cognitive tasks.

This innovative approach suggests that cognitive-physical training tools can enhance cognitive function while being used at home, potentially improving treatment efficacy for cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can physical and cognitive training based on episodic memory be combined in a new protocol for daily training? Maselli, M., Fiorini, L., Cecchi, F., et al.[2020]

A study involving 22 young adults found that visual working memory (WM) training was more effective than auditory WM training in reducing dual-task interference, which can lead to accidents.

Participants underwent 2 weeks of training using either auditory or visual stimuli, and the results suggest that focusing on visual tasks may better enhance cognitive performance in multitasking situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Auditory or Visual Working Memory Training on Dual-Task Interference. Kimura, T., Matsuura, R.[2021]

A study involving 22 older adults showed that both cognitive training and combined cognitive and physical training improved working memory and executive function after eight weeks, with significant behavioral improvements in tasks like Updated Span and n-back.

While both training types led to similar cognitive benefits, the study could not definitively conclude that combined training offers a direct advantage over cognitive training alone; however, it may enhance overall fitness and make training more appealing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural and ERP Effects of Cognitive and Combined Cognitive and Physical Training on Working Memory and Executive Function in Healthy Older Adults. Chainay, H., Joubert, C., Massol, S.[2022]

Cognitive training significantly improved working memory (WM) performance in 141 healthy older adults (average age 70) over four months, as evidenced by better target detection in the n-back task and increased performance in the backward digit-span test.

The cognitive training led to enhanced brain activity, indicated by increased P3a and P3b event-related potentials, suggesting that this type of training boosts the brain's ability to maintain and process information, unlike physical or no-contact control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ERP and Behavioral Effects of Physical and Cognitive Training on Working Memory in Aging: A Randomized Controlled Study. Gajewski, PD., Falkenstein, M.[2019]

Visual working memory training leads to significantly greater improvements compared to auditory training or no training, as shown by a study using functional magnetic resonance imaging (fMRI) to assess brain activity during a visual 2-back task.

The training specifically enhances visual memory processes while also improving general control processes, indicating that visual working memory can be trained independently from auditory memory.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Separating intra-modal and across-modal training effects in visual working memory: an fMRI investigation. Schneiders, JA., Opitz, B., Krick, CM., et al.[2011]

A scoping review of 130 articles revealed that over half (58%) of cognitive training trials excluded older adults with hearing and/or vision impairments, indicating a significant underrepresentation of this high-risk group in research.

Only a small number of studies (16% for cognitive and 11% for multimodal interventions) reported on hearing and vision measurements, and very few incorporated accessibility features, raising concerns about the applicability of trial results to the broader population of older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inclusion of hearing and vision impairments in cognitive training interventions. Marino, FR., Jiang, K., Smith, JR., et al.[2023]

Cognitive training (CT) shows small to moderate positive effects on global cognition and verbal semantic fluency in people with mild to moderate dementia, with these benefits lasting for 3 to 12 months after treatment, based on a systematic review of 33 trials involving various sample sizes.

Compared to alternative treatments, CT may have little to no effect on global cognition, indicating that while CT can be beneficial, its efficacy may not surpass that of other non-pharmacological interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training for people with mild to moderate dementia. Bahar-Fuchs, A., Martyr, A., Goh, AM., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

[User friendliness of computer-based cognitive training for psychogeriatric patients with mild to moderate cognitive impairments]. [2016]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of Paper-Based Cognitive Training in Early Stage of Alzheimer's Dementia. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

Computerized attention training for visually impaired older adults with dementia: a case study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Measuring the impact of cognitive and psychosocial interventions in persons with mild cognitive impairment with a randomized single-blind controlled trial: rationale and design of the MEMO+ study. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Can physical and cognitive training based on episodic memory be combined in a new protocol for daily training? [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Effect of Auditory or Visual Working Memory Training on Dual-Task Interference. [2021]

8. Poland pubmed.ncbi.nlm.nih.gov

Behavioural and ERP Effects of Cognitive and Combined Cognitive and Physical Training on Working Memory and Executive Function in Healthy Older Adults. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

ERP and Behavioral Effects of Physical and Cognitive Training on Working Memory in Aging: A Randomized Controlled Study. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Separating intra-modal and across-modal training effects in visual working memory: an fMRI investigation. [2011]

11. United States pubmed.ncbi.nlm.nih.gov

Inclusion of hearing and vision impairments in cognitive training interventions. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Cognitive training for people with mild to moderate dementia. [2022]