StrokeNCT04098835
A Pilot Study of a Strategy and Computer-based Intervention to Enhance Daily Cognitive Functioning After Stroke
A study testing ASCEND in people with Stroke, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
This is an initial pilot study to test feasibility, participant engagement and satisfaction, and clinical and neurobiological target engagement of a behavioral treatment called "ASCEND" that combines computer-based cognitive training and coaching of cognitive strategies to improve daily cognitive functioning in… Read more about this study
- Who is it for?
- Ages 45 to 89 years
- Conditions the study is for
- Stroke
- What is being tested?
- ASCEND
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2019to 13 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of first-time stroke, minimum of 6 months prior to enrollment
- English speaking
- Ability to comprehend sufficiently to participate in the treatment.
- Subjective or objective evidence of mild cognitive impairment
- Willingness to participate in full study duration
- Has computer that meets specification for the training program software.
Show all 9Show fewer
- Physically able to operate a computer keyboard and mouse.
- Not concurrently receiving other cognitive rehabilitation services
- Cognitively able to perform basic self-care activities (e.g., dressing, grooming, eating).
Who cannot join
- History of neurologic disease other than stroke
- History of severe mental illness or substance use disorder, or current major depressive episode.
- History of dementia or dependence in basic self-care activities due to cognitive deficits
- Contraindications to MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065
About this study
This is an initial pilot study to test feasibility, participant engagement and satisfaction, and clinical and neurobiological target engagement of a behavioral treatment called "ASCEND" that combines computer-based cognitive training and coaching of cognitive strategies to improve daily cognitive functioning in individuals with stroke.
- Conditions
- Stroke
- Being tested
- ASCEND
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASCENDBehavioural
ASCEND is a behavioral intervention that combines computer-based cognitive exercise, strategy coaching with a neuropsychologist, and homework exercises in order to improve attention, working memory, and cognitive control after stroke.
| Study group | Role | What they receive |
|---|---|---|
| ASCEND | Experimental | ASCEND combines computer-based cognitive training exercises, homework exercises to enhance cognition, and coaching sessions delivered in-person and via telephone/videoconference by a neuropsychologist. ASCEND includes 24 total computer training sessions of 30 minutes each, for a total of 12 hours. ASCEND includes 8 coaching sessions of 45 minutes each. The computer exercises aim to improve attention, working memory (WM), and cognitive control through a series of engaging and interactive computer games (e.g., card games, driving simulation). The homework exercises and coaching sessions aim to assist the participant in generalizing and transferring skills from the computer exercises to daily life and to develop further strategies to compensate for attention and WM difficulties in daily life. Receives: Behavioral: ASCEND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant satisfaction with ASCEND, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8)
The CSQ-8 is a self-report measure of participant satisfaction with the intervention. Scores range from 8-32 with higher scores indicating greater satisfaction.
Measured: 5 weeks (at the conclusion of treatment)
Participant impression of ASCEND as a credible treatment to improve cognition, as measured by the Credibility and Expectancy Questionnaire (CEQ).
The CEQ is a self-report measure that assesses participants' perceived benefit and improvement from the intervention. Each item is scored on a 1-9 Likert-type scale or as a percentage rating from 0% to 100% in 10% increments.
Measured: 5 weeks (at the conclusion of treatment)
Secondary outcomes (10)
Change in auditory attention and working memory, as measured by the Digit Span test
Performance-based measure of attention/working memory with scores ranging from 0-48, with higher scores indicating better performance.
Measured: Baseline, 5 weeks
Change in visual attention and working memory, as measured by the Symbol Span test
Performance-based measure of attention/working memory with scores ranging from 0-50, with higher scores indicating better performance.
Measured: Baseline, 5 weeks
Change in divided attention and working memory, as measured by the Symbol-Digit Modalities Test
Performance-based measure of divided attention/working memory with scores ranging from 0-120, with higher scores indicating better performance.
Measured: Baseline, 5 weeks
Change in divided attention and processing speed, as measured by the Trail Making Test
Performance-based and timed measure of divided attention/processing speed with lower scores indicating better performance (faster completion time).
Measured: Baseline, 5 weeks
Change in selective attention and inhibitory control, as measured by the Stroop Test
Performance-based and timed measure of selective attention and inhibition, with higher scores indicating better performance.
Measured: Baseline, 5 weeks
Change in rapid working memory and mental arithmetic, as measured by the Paced Auditory Serial Addition Test (PASAT)
Performance-based and timed measure of rapid working memory, with higher scores indicating better performance.
Measured: Baseline, 5 weeks
Change in attention and working memory as measured by the Mental Control test
Performance-based measure of simple auditory attention and working memory. Scores range from 0-12 with higher scores indicating better performance.
Measured: Baseline, 5 weeks
Change in executive functioning as measured by the Weekly Calendar Planning Activity
Performance-based measure of executive functioning. Higher scores indicate better performance.
Measured: Baseline, 5 weeks
Change in self-reported executive functioning as measured by the Behavior Rating Inventory of Executive Function-Adult
Self-report measure of executive functioning. Higher scores indicate greater problems with executive dysfunction in daily life.
Measured: Baseline, 5 weeks
Change in self-reported cognitive symptoms due to stroke, as measured by the Patient Reported Evaluation of Cognitive State (PRECIS).
Self-report measure of cognitive difficulties after stroke. Scores range from 0-128 with higher scores indicating greater cognitive problems in daily life due to stroke.
Measured: Baseline, 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start13 Dec 2019
- Primary completion13 Feb 2020
- Study completion13 Feb 2020
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abhishek Jaywant, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098835
- Sponsor's protocol ID
- 19-06020310
- Status last verified
- May 2023
- First submitted
- 18 Sep 2019
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Strategy and Computer-based Intervention to Enhance Daily Cognitive Functioning After Stroke
- ClinicalTrials.gov ID
- NCT04098835
- Acronym / sponsor ID
- 19-06020310
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 13 Feb 2020 (actual)
- Study completion
- 13 Feb 2020 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an initial pilot study to test feasibility, participant engagement and satisfaction, and clinical and neurobiological target engagement of a behavioral treatment called "ASCEND" that combines computer-based cognitive training and coaching of cognitive strategies to improve daily cognitive functioning in individuals with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASCEND | Experimental | Behavioral: ASCENDASCEND combines computer-based cognitive training exercises, homework exercises to enhance cognition, and coaching sessions delivered in-person and via telephone/videoconference by a neuropsychologist. ASCEND includes 24 total computer training sessions of 30 minutes each, for a total of 12 hours. ASCEND includes 8 coaching sessions of 45 minutes each. The computer exercises aim to improve attention, working memory (WM), and cognitive control through a series of engaging and interactive computer games (e.g., card games, driving simulation). The homework exercises and coaching sessions aim to assist the participant in generalizing and transferring skills from the computer exercises to daily life and to develop further strategies to compensate for attention and WM difficulties in daily life. |
Who may qualify
- Ages
- 45 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- History of first-time stroke, minimum of 6 months prior to enrollment
- English speaking
- Ability to comprehend sufficiently to participate in the treatment.
- Subjective or objective evidence of mild cognitive impairment
- Willingness to participate in full study duration
Key exclusion criteria (4 listed)
- History of neurologic disease other than stroke
- History of severe mental illness or substance use disorder, or current major depressive episode.
- History of dementia or dependence in basic self-care activities due to cognitive deficits
- Contraindications to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASCENDASCEND is a behavioral intervention that combines computer-based cognitive exercise, strategy coaching with a neuropsychologist, and homework exercises in order to improve attention, working memory, and cognitive control after stroke. | Behavioural | ASCEND |
Primary outcome
Participant satisfaction with ASCEND, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: 5 weeks (at the conclusion of treatment)
The CSQ-8 is a self-report measure of participant satisfaction with the intervention. Scores range from 8-32 with higher scores indicating greater satisfaction.
Participant impression of ASCEND as a credible treatment to improve cognition, as measured by the Credibility and Expectancy Questionnaire (CEQ).
Time frame: 5 weeks (at the conclusion of treatment)
The CEQ is a self-report measure that assesses participants' perceived benefit and improvement from the intervention. Each item is scored on a 1-9 Likert-type scale or as a percentage rating from 0% to 100% in 10% increments.
10 secondary outcomes
Change in auditory attention and working memory, as measured by the Digit Span test
Time frame: Baseline, 5 weeks
Change in visual attention and working memory, as measured by the Symbol Span test
Time frame: Baseline, 5 weeks
Change in divided attention and working memory, as measured by the Symbol-Digit Modalities Test
Time frame: Baseline, 5 weeks
Change in divided attention and processing speed, as measured by the Trail Making Test
Time frame: Baseline, 5 weeks
Change in selective attention and inhibitory control, as measured by the Stroop Test
Time frame: Baseline, 5 weeks
Change in rapid working memory and mental arithmetic, as measured by the Paced Auditory Serial Addition Test (PASAT)
Time frame: Baseline, 5 weeks
Change in attention and working memory as measured by the Mental Control test
Time frame: Baseline, 5 weeks
Change in executive functioning as measured by the Weekly Calendar Planning Activity
Time frame: Baseline, 5 weeks
Change in self-reported executive functioning as measured by the Behavior Rating Inventory of Executive Function-Adult
Time frame: Baseline, 5 weeks
Change in self-reported cognitive symptoms due to stroke, as measured by the Patient Reported Evaluation of Cognitive State (PRECIS).
Time frame: Baseline, 5 weeks
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhishek Jaywant, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASCEND in people with Stroke, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant satisfaction with ASCEND, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8) (time frame: 5 weeks (at the conclusion of treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.