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

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called ASCEND-I, which combines computer training and coaching to help improve memory and thinking skills after a stroke. Researchers aim to determine if this approach is more effective than the usual therapy, which focuses more generally on cognition. Participants will either try the new program or continue with their standard therapy. The trial seeks individuals who have had a stroke, experience mild to moderate memory and thinking issues, and can use a computer or tablet.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance post-stroke recovery options.

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 prior data suggests that this cognitive training intervention is safe for post-stroke patients?

Research shows that digital programs like ASCEND-I are generally easy for participants to use. ASCEND-I combines computer-based brain exercises with coaching sessions to help improve memory and thinking skills after a stroke. Previous studies have found that digital brain training tools are safe and have few side effects.

Participants usually engage in these activities during regular rehab sessions, which makes it easy to incorporate into daily routines. Although specific safety data for ASCEND-I is not yet available, similar digital programs have not reported major problems. This suggests that ASCEND-I is likely safe for use, especially since it is designed to complement existing therapy practices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ASCEND-I for post-stroke cognitive impairment because it offers a unique approach by combining computerized working memory training with the Multicontext method. Unlike standard occupational therapy, which often lacks targeted cognitive training, ASCEND-I provides tailored exercises that adapt to each participant’s ability level and performance changes. This treatment is distinctive because it not only focuses on enhancing working memory through repetitive, functionally-relevant activities but also emphasizes self-discovery and strategy development, helping patients to anticipate and manage their cognitive challenges effectively.

What evidence suggests that ASCEND-I is effective for post-stroke cognitive impairment?

Research shows that computer-based brain training can improve thinking skills in stroke patients. In this trial, participants may receive the ASCEND-I program, which combines computer exercises with strategy coaching to enhance memory and decision-making abilities. Studies have found that similar programs improve everyday thinking tasks. This method helps individuals predict and manage memory challenges through practice and guided learning. Overall, the combination of specific exercises and personalized coaching in ASCEND-I appears promising for enhancing cognitive recovery after a stroke. ^{1 2 3 6 7}

Who Is on the Research Team?

Abhishek Jaywant, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the ASCEND-I intervention, which includes computer-based cognitive training and coaching of cognitive strategies to improve working memory and executive functions.

2 weeks

Daily sessions

Follow-up

Participants are monitored for changes in working memory and cognitive functioning after the treatment phase.

2 weeks

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04098835

A Pilot Study of a Strategy and Computer-based ... ASCEND is a behavioral intervention that combines computer-based cognitive exercise, strategy coaching with a neuropsychologist, and homework exercises in order ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04472351/cognitive-training-in-stroke-rehabilitation

Cognitive Training in Stroke Rehabilitation This is a randomized, controlled pilot study to evaluate the efficacy of "ASCEND-I" (A Strategy and Computer-based intervention to ENhance ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04472351

NCT04472351 | Cognitive Training in Stroke Rehabilitation ASCEND-I combines computer-based cognitive training exercises, with structured coaching sessions within patients' occupational therapy. Computer-based training ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12405420/

Effectiveness of computer-assisted cognitive training on ... This study aimed to investigate the effects of computer-assisted cognitive training (CACT) on cognitive function and activities of daily living ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12288705/

Digital Interventions for Cognitive Dysfunction in Patients With ... Effects of computer-assisted cognitive training on post-stroke cognitive impairment and neurotransmitter levels. NI-FR. 2021;16(12):772–773 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12292376/

Technology-Enabled Cognitive Strategy Intervention for ... Objective: To examine the feasibility, safety, acceptability, and suitability of a virtually-delivered vascular risk reduction intervention that ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1876201825001030

Post-stroke cognitive impairment and dementia research in ... This cognitive decline may occur due to disrupted blood and oxygen flow to brain tissues, ongoing inflammation, damage to axonal pathways, or alterations in ...