Cognitive Training for Post-Stroke Cognitive Impairment

Overseen By Abhishek Jaywant, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Parkinson's, Multiple Sclerosis, Alzheimer's, others

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

Compensation: Varies

Number of Visits: Unknown

27 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized, controlled pilot study to evaluate the efficacy of "ASCEND-I" (A Strategy and Computer-based intervention to ENhance Daily cognitive functioning after stroke - Inpatient), an inpatient intervention that combines computer-based cognitive training and coaching of cognitive strategies to improve working memory (WM) and related executive functions in individuals with stroke. The investigators hypothesize that relative to an "enhanced usual care" control condition, ASCEND will be associated with improvements in WM. The investigators also hypothesize that measures of baseline brain connectivity (assessed via participants' routine clinical magnetic resonance imaging scans) will predict response to ASCEND-I.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Cognitive Training for Post-Stroke Cognitive Impairment is an effective treatment?

The available research shows that cognitive training can improve everyday functioning in stroke patients. One study found that patients who received attention training reported better everyday functioning compared to those who did not receive the training. This suggests that cognitive training can help stroke survivors manage daily tasks more effectively. Additionally, computer-assisted cognitive rehabilitation has been shown to improve cognitive function in patients with post-stroke cognitive impairment, indicating its potential effectiveness as a treatment. ^{1 2 3 4 5}

What safety data exists for cognitive training in post-stroke patients?

The provided research abstracts focus on the efficacy and benefits of computer-based cognitive rehabilitation (CBCR) for stroke patients, but they do not specifically address safety data. The studies primarily evaluate the effectiveness of cognitive training on improving cognitive functions and working memory impairment after stroke. For specific safety data, further investigation into clinical trials or studies explicitly assessing safety outcomes would be necessary. ^{1 2 5 6 7}

Is the treatment ASCEND-I a promising treatment for improving cognitive function after a stroke?

Yes, ASCEND-I is a promising treatment for improving cognitive function after a stroke. It uses computer-based exercises to help improve memory and attention, which are often affected by strokes. This type of treatment can be done at home, making it convenient and accessible for many people. Studies have shown that similar computer-based cognitive training can lead to improvements in everyday functioning for stroke survivors. ^{1 2 4 5 8}

Research Team

Abhishek Jaywant, PhD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for English-speaking adults aged 30-89 who have had a stroke and are in acute inpatient rehab. They must understand the treatment, be able to use a computer, and show mild-moderate cognitive impairment without severe mental illness, substance abuse history, or other neurological disorders.

Inclusion Criteria

English speaking

I can use a computer, tablet, or mouse without help.

I understand what the treatment involves and can follow instructions.

Exclusion Criteria

You have a history of memory loss or forgetfulness (dementia).

Any factor that in the investigator's opinion is likely to compromise the subject's ability to participate in the study, including evidence that the subject may not understand and/or adhere to study requirements

I have a neurological disorder but no lasting effects from any strokes.

Treatment Details

Interventions

• ASCEND-I

Trial Overview The 'ASCEND-I' program is being tested against enhanced usual care to see if it improves working memory and executive functions after a stroke. It involves computer-based training and strategy coaching. Brain scans may help predict who will benefit most.

Participant Groups

Group I: ASCEND-I Experimental Treatment 1 Intervention

Computerized WM training with Rehacom will be implemented in daily 30-minute sessions that are scheduled prior to the participant's occupational therapy (OT) session as an adjunct to routine rehabilitation. Tasks are tailored to the participant's current ability level and are adaptive to performance changes. During these sessions, the study staff member will use guided questioning to help the participant anticipate challenges, reflect on performance, and link computerized exercises to the Multicontext sessions. The Multicontext treatment sessions will be delivered within the participant's OT session by an OT. The Multicontext approach helps individuals to self-discover WM-related error patterns and learn to anticipate WM performance challenges through repeated practice using functionally-relevant activities. The OT conducts guided questioning pre- and post-task to help the participant anticipate challenges and self-discover WM strategies.

Group II: Enhanced Usual Care Active Control 1 Intervention

The control condition will account for the time spent with rehabilitation therapists and study staff and provide more general cognitive stimulation. The control group will receive usual, standard of care occupational therapy during OT by inpatient rehabilitation staff who are not trained in the Multicontext approach. The standard OT session often focuses on cognition in a non-standardized and non-targeted manner without the targeting of WM and guided self-discovery of the Multicontext approach. To control for the cognitive training element of ASCEND, individuals randomized to the control condition will meet with a study staff member for 30 minutes of general cognitive stimulation that includes word-searches, crossword puzzles, and/or jigsaw puzzles.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Findings from Research

A systematic review of 32 studies with 1837 participants found that computer-assisted cognitive rehabilitation significantly improved cognitive function in post-stroke patients compared to conventional therapy alone, as measured by various cognitive assessments (p < .01).

The addition of computer-assisted cognitive rehabilitation also enhanced patients' activities of daily living, indicating its effectiveness in restoring overall functional abilities after a stroke (p < .05).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of computer-assisted cognitive rehabilitation on cognitive impairment after stroke: A systematic review and meta-analysis. Nie, P., Liu, F., Lin, S., et al.[2022]

Stroke survivors may appear cognitively unimpaired on standard tests like the MMSE, but they actually show significant deficits in specific cognitive areas such as visual attention and memory when assessed with novel task-oriented tools.

The study highlights the need for a standardized, multidomain cognitive assessment to better identify and address subtle cognitive deficits in stroke patients, which is crucial for effective rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subtle memory and attentional deficits revealed in an Irish stroke patient sample using domain-specific cognitive tasks. Duffin, JT., Collins, DR., Coughlan, T., et al.[2012]

The Weekly Calendar Planning Activity (WCPA-10) effectively differentiates between stroke patients in acute rehabilitation and healthy individuals, revealing significant deficits in cognitive-instrumental activities of daily living (C-IADL) among stroke patients.

Even stroke patients who screened as having normal cognitive function on standard tests showed limitations in C-IADL performance, indicating the importance of using functional assessments like the WCPA-10 for a more accurate understanding of cognitive recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impaired Performance on a Cognitively-Based Instrumental Activities of Daily Living Task, the 10-Item Weekly Calendar Planning Activity, in Individuals With Stroke Undergoing Acute Inpatient Rehabilitation. Jaywant, A., Arora, C., Lussier, A., et al.[2021]

In a study involving 80 stroke patients, 4 weeks of online adaptive attention training (SAT) led to significant improvements in everyday functioning, particularly for those with spatial impairments, compared to working memory training and a waitlist group.

While no significant changes were observed in cognitive test performance, the positive patient-reported outcomes suggest that SAT may be a valuable low-cost adjunct to rehabilitation services for enhancing daily life after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized control trial of the effects of home-based online attention training and working memory training on cognition and everyday function in a community stroke sample. Peers, PV., Punton, SF., Murphy, FC., et al.[2023]

A systematic review of computer-based cognitive rehabilitation (CBCR) for working memory impairment after stroke found insufficient evidence to determine its effectiveness, as studies showed highly variable results and used different measures of working memory.

No harmful effects were reported from CBCR interventions, but the lack of meaningful differences in working memory improvement compared to control groups suggests that more research is needed to assess its true benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Computer Based Cognitive Rehabilitation in Stroke Patients with Working Memory Impairment: A Systematic Review. Niemeijer, M., Sværke, KW., Christensen, HK.[2020]

A meta-analysis of 17 studies involving 622 stroke patients found that computerized cognitive training significantly enhances cognitive functions such as global cognition, working memory, attention, and executive function.

Despite these cognitive improvements, the training did not show significant effects on patients' daily living activities or depression, indicating that while cognitive training is beneficial, its impact on overall quality of life needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of computerized cognitive training on improving cognitive functions of stroke patients: A systematic review and meta-analysis of randomized controlled trials. Zhou, Y., Feng, H., Li, G., et al.[2022]

In a study of 384 older stroke patients undergoing an 8-week home-based rehabilitation, therapy intensity was found to significantly influence functional recovery, particularly for those with cognitive impairment.

Cognitively impaired patients benefited more from moderate-intensity rehabilitation, while those without cognitive impairment showed greater functional gains with high-intensity therapy, suggesting tailored rehabilitation approaches based on cognitive status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional recovery of older stroke patients discharged from hospital to home: The effects of cognitive status and different levels of therapy intensity. Liu, H., Lou, VWQ.[2019]

The Oxford Cognitive Screen-Plus (OCS-Plus) is an effective tool for detecting subtle cognitive impairments in stroke survivors, outperforming standard screening tools like the MoCA and OCS, with 100% sensitivity for those previously classified as unimpaired.

In a study of 347 stroke survivors, the OCS-Plus demonstrated strong validity in comparison to established neuropsychological tests, confirming its potential as a reliable screening method for cognitive issues post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the UK English Oxford cognitive screen-plus in sub-acute and chronic stroke survivors. Webb, SS., Hobden, G., Roberts, R., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The effects of computer-assisted cognitive rehabilitation on cognitive impairment after stroke: A systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Subtle memory and attentional deficits revealed in an Irish stroke patient sample using domain-specific cognitive tasks. [2012]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Impaired Performance on a Cognitively-Based Instrumental Activities of Daily Living Task, the 10-Item Weekly Calendar Planning Activity, in Individuals With Stroke Undergoing Acute Inpatient Rehabilitation. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A randomized control trial of the effects of home-based online attention training and working memory training on cognition and everyday function in a community stroke sample. [2023]

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

The Effects of Computer Based Cognitive Rehabilitation in Stroke Patients with Working Memory Impairment: A Systematic Review. [2020]

6. Australia pubmed.ncbi.nlm.nih.gov

Efficacy of computerized cognitive training on improving cognitive functions of stroke patients: A systematic review and meta-analysis of randomized controlled trials. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Functional recovery of older stroke patients discharged from hospital to home: The effects of cognitive status and different levels of therapy intensity. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Validation of the UK English Oxford cognitive screen-plus in sub-acute and chronic stroke survivors. [2022]