NCT06479174 · University of New Mexico
Cognitive Strategies for Optimizing Brain Health And Managing Transgenerational Vascular Risk Factors Post-Stroke
(CHAMPS-TR)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
CHAMPS-TR
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).
Primary outcome measures
American Heart Association Life's Essential 8 Metrics
Time frame: baseline, up to 7 weeks, and up to 24 weeks
metric scores for vascular risk; score is calculated on a 0-100 scale where 100 is ideal
Cardiovascular risk factors, Aging, and Incidence of Dementia (CAIDE)
Time frame: baseline, up to 7 weeks, and up to 24 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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),
- absence of major anxiety and depressive disorder (PHQ-9, GAD-7),
- absence of drug and alcohol misuse within 3 months of study (AUDIT, DAST),
- greater than 40 years of age,
- having a potential family member who meets targeted family member criteria,
- eligible for MRI and Remote Supervised-transcranial direct current stimulation (RS-tDCS) if in CHAMPS-TR plus RS-tDCS (e.g., not pregnant; no intracranial metal implants; no skin lesions on target sites for stimulation; no severe cardiopulmonary, renal or hepatic diseases; no pacemakers; no underlying medical reason for not engaging in MRI or tDCS). The targeted family member will be:
- a minimum of 18 years of age,
- biological kin of person with stroke,
- absence of dementia (client report),
- absence of major anxiety and depressive disorder (PHQ-9, GAD-7),
- absence of drug and alcohol misuse within 3 months of study (AUDIT, DAST),
- greater than 18 years of age, and
- having a sibling or parent who had an ischemic stroke
Exclusion criteria
- For all participants:
- not English speaking, reading, and understanding, and
- no access to video-conference software on a computer or smart device
Where
- Albuquerque, New Mexico
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 11, 2026 · Source of record for eligibility and locations