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Behavioral Intervention

Cognitive Training for Post-Stroke Cognitive Impairment

N/A

Recruiting

Led By Abhishek Jaywant, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Physically able to operate a computer keyboard, tablet/iPad, and mouse.

Ability to comprehend sufficiently to participate in the treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, end of study (approximately 2 weeks)

Awards & highlights

Study Summary

This trial will test a new intervention to help improve working memory and executive function in stroke patients. The intervention combines computer-based cognitive training with coaching of cognitive strategies. The investigators hypothesize that, compared to an Enhanced Usual Care control condition, the ASCEND intervention will lead to improvements in working memory.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since ASCEND-I involves non-invasive cognitive training and coaching strategies rather than medication or surgery, side effects are minimal but could include fatigue or frustration during tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I understand what the treatment involves and can follow instructions.

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I am between 30 and 89 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, end of study (approximately 2 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, end of study (approximately 2 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of study (approximately 2 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The primary objective is to determine whether ASCEND improves WM as assessed by computerized WM tasks from the Tablet-based Computer Assessment Tool (TabCAT) and the Weekly Calendar Planning Activity.

Secondary outcome measures

Change from baseline in cognitive functioning, as measured by the NeuroQOL (Quality of Life in Neurological disorders) Cognitive Function Short Form.

Change from baseline in strategy use, as measured by the Weekly Calendar Planning Activity (WCPA)

Memory

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ASCEND-IExperimental Treatment1 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 CareActive Control1 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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,316,239 Total Patients Enrolled

Abhishek Jaywant, PhDPrincipal InvestigatorWeill Medical College of Cornell University

3 Previous Clinical Trials

75 Total Patients Enrolled

Media Library

ASCEND-I (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04472351 — N/A

Cognitive Impairment Research Study Groups: ASCEND-I, Enhanced Usual Care

Cognitive Impairment Clinical Trial 2023: ASCEND-I Highlights & Side Effects. Trial Name: NCT04472351 — N/A

ASCEND-I (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04472351 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications does a person need to be accepted into this clinical investigation?

"This medical trial seeks 70 participants between the ages of 30 and 89, who have been diagnosed with cognitive impairment (CI). In order to be considered eligible for this study, individuals must meet the following criteria: they should possess physical dexterity necessary to use a keyboard, mouse or iPad; have recently experienced a stroke and accepted inpatient rehabilitation from NYP-Weill Cornell; speak English fluently; comprehend complex instructions well enough to follow through on treatment plans prescribed by clinical professionals; demonstrate mild-moderate CI as confirmed via standardized tests administered by OTs such as Montreal Cognitive Assessment, Symbol-Digit Modalities Test or any other instruments approved within"

Answered by AI

Is the participant eligibility criteria for this research restricted to adults above 18 years of age?

"This clinical trial requires that participants be aged between 30 and 89 years old. Alternatively, there are 37 trials specifically aimed at minors and 579 studies for patients above the pensionable age."

Answered by AI

Are there open spots to participate in this experiment?

"Clinicaltrials.gov shows this trial is actively accepting participants, having been posted on the 12th of January 2021 and last updated on March 25th 2022."

Answered by AI

What is the maximum number of participants being accepted into this research project?

"Indeed, the clinical trial portal shows that this research is still in its participant recruitment phase. It was initially posted on December 1st 2021 and underwent a revised edit about two months ago. 70 individuals need to be enrolled from one location for it to continue."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cognitive Training in Stroke Rehabilitation

2021. "Cognitive Training in Stroke Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04472351.