Cognitive Strategies for Optimizing Brain Health And Managing Transgenerational Vascular Risk Factors Post-Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of New Mexico

About this trial

People living with the cognitive effects of stroke are at risk for recurrent stroke and further cognitive decline. Also problematic is that stroke risk clusters in families and biological family members of people who have ischemic stroke may also be at increased risk of stroke and/or cognitive decline. The primary goal of this study is to test the feasibility of a virtually delivered cognitive strategy training and health coaching program to reduce vascular risk and promote brain health in persons with stroke and their biological family members.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

primary diagnosis of acute ischemic stroke,

impairment of cognitive function (score >1 on Quick Executive Interview - telephone screener),

absence of severe aphasia (score of 0 or 1 on NIH Stroke Scale),

absence of pre-stroke dementia (client report),

Disqualifiers

not English speaking, reading, and understanding, and

no access to video-conference software on a computer or smart device

Trial design

Design model

Parallel

Treatments tested in this trial

  • CHAMPS-TR

    Behavioral

    Persons with stroke ( n=20) and at least 1 targeted family member (TFM) (n=20) will engage with the CHAMPS-TR protocol which involves 10 virtual intervention sessions (bi-weekly for 5 weeks) with key elements including metacognitive problem-solving training (i.e., goal setting, guided discovery, strategy development) and vascular risk reduction coaching building on existing American Heart Association (AHA) LE8 content. Probands that are eligible for RS-tDCS (n=10) will receive 5x weekly (weeks 2-5) RS-tDCS applied to the left dorsolateral prefrontal cortex (DLPFC).

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: CHAMPS-TRExperimental treatment 1 intervention
Group B: CHAMPS TR plus remotely supervised transcranial direct current stimulation (RS-tDCS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

American Heart Association Life's Essential 8 Metrics

metric scores for vascular risk; score is calculated on a 0-100 scale where 100 is ideal

Time frame
baseline, up to 7 weeks, and up to 24 weeks
2

Cardiovascular risk factors, Aging, and Incidence of Dementia (CAIDE)

Risk profile score for cognitive decline; score is composed of weightings by reference to age, sex, education, systolic blood pressure, BMI, total cholesterol, and physical activity. Scores range from 0-15 with higher scores indicating greater risk.

Time frame
baseline, up to 7 weeks, and up to 24 weeks

Secondary outcomes

1

Oral Trail Making Test Part B

Test of mental sequencing and switching; score with total number of seconds to complete up to 300, total number of errors, and total correct

Time frame
baseline and up to 24 weeks
2

Number Span Test Forward and Backward

Test of working memory; scored with number of correct trials (0-14), and longest span forward (0, 3-9) and longest span backward (0, 2-8). Higher numbers are greater number of correct items.

Time frame
baseline and up to 24 weeks
3

Multiple Errands Test Home Version

Test of executive function impact on everyday life; total score of 0-14 with higher levels indicating less impairment; additional sub-scores for errors made and strategies used using total scores.

Time frame
baseline and up to 24 weeks
4

Mark VCID2 Clinical Cognitive Assessment Battery

Test of cognitive impairment and dementia; total scores on all sub-scores for each included measure.

Time frame
baseline and up to 24 weeks

Other outcomes

Sponsors and contacts

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