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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
No Placebo-Only Group
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.
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.
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 belowSelect...
I can use a computer, tablet, or mouse without help.
Select...
I understand what the treatment involves and can follow instructions.
Select...
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)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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 study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,092 Previous Clinical Trials
1,154,716 Total Patients Enrolled
Abhishek Jaywant, PhDPrincipal InvestigatorWeill Medical College of Cornell University
4 Previous Clinical Trials
85 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of memory loss or forgetfulness (dementia).I have a neurological disorder but no lasting effects from any strokes.I can use a computer, tablet, or mouse without help.I understand what the treatment involves and can follow instructions.I am between 30 and 89 years old.You have a history of severe mental illness like schizophrenia or substance abuse disorder within the past year. However, post-stroke depression is not a reason for exclusion.You have a significant difficulty in paying attention to one side of your body, as determined by an occupational therapist evaluation.You are willing to stay in the study for the entire duration.
Research Study Groups:
This trial has the following groups:- Group 1: ASCEND-I
- Group 2: Enhanced Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.