An interventional study of CHAMPS-TR in Stroke, Ischemic, sponsored by University of New Mexico. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by University of New Mexico · Not applicable, Interventional, and Prevention
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.
CHAMPS for Transgenerational Risk (TR) (Cognitive strategies for optimizing brain Health And Managing transgenerational vascular risk factors Post-Stroke), a feasibility trial for preventing stroke and improving cognitive outcomes in persons with stroke and their families. Stroke is used as a vector to identify both persons with post-stroke cognitive impairment and dementia (PSCID)and a targeted family member who may be at risk and could benefit from vascular risk reduction intervention. The investigators integrate the concept of a "teachable moment" where health events can lead to behavior change by targeting family members who are stroke-free but may have vascular risk factors putting them at risk for stroke and vascular cognitive impairment (VCI) in the future. Recognizing that people with stroke frequently encounter barriers to community mobility, the proposed trial will be offered virtually to give even those with difficulty accessing the community an equitable opportunity to participate in clinical research.
In this feasibility trial, the investigators will pilot test the CHAMPS-TR intervention which includes vascular risk reduction coaching and a metacognitive problem-solving protocol which contains guided discovery, goal setting, and strategy training. Index persons with stroke and targeted family members (i.e., biological child, younger sibling) who may be at heightened risk for stroke and VCI will receive the CHAMPS intervention which will be delivered remotely. Participants will be split into two arms and either receive the virtual CHAMPS-TR intervention or CHAMPS-TR intervention plus remotely-supervised transcranial Direct Current Stimulation (RS-tDCS) based on eligibility and preference. tDCS is a minimally invasive brain stimulation technique that may augment the effects of cognitive interventions alone. It has strong evidence in stroke rehabilitation and RS-tDCS is a feasible approach in those with stroke and other clinical populations. The overarching goal of this project is to rigorously test the custom-tailored intervention for families impacted by ischemic stroke.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →University of New Mexico is the lead sponsor of 313 studies on the registry; 29 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The targeted family member will be:
Exclusion Criteria:
For all participants:
Persons with stroke and a targeted biological family member will receive the CHAMPS intervention including vascular risk reduction coaching and cognitive strategy training.
Behavioral: CHAMPS-TR
Persons with stroke and a targeted biological family member will receive the CHAMPS intervention including vascular risk reduction coaching and cognitive strategy training. Persons with stroke will also receive RS-tDCS.
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).
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
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
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
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
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
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
PROMIS Self-Efficacy for Managing Medications
Test of self efficacy for managing medications; scoring with item-level calibrations using HealthMeasures Scoring Service
Time frame: baseline, up to 7 weeks, and up to 24 weeks
PROMIS Self-Efficacy for Managing Symptoms
Test of self efficacy for managing symptoms; scoring with item-level calibrations using HealthMeasures Scoring Service
Time frame: baseline, up to 7 weeks, and up to 24 weeks
Plan to share: Yes — Data Sharing Plan The investigators will share data collected in this project: At National Scientific Meetings: The investigators expect to share results from the data at two conferences/scientific meetings a year such as the American Congress of Medical Rehabilitation Conference, the RESNA conference, the American Occupational Therapy Conference, and Aging Conferences. Through Publication in Scientific Journals: the investigators expect to publish 1-2 journal articles a year where data from the proposed project will be shared with no subject identifiers. Data to be shared includes de-identified: MRI data, feasibility data, self-efficacy scores, vascular risk factor scores, cognitive/executive function scores
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Oct 2026, 36 months after the start.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 36 months is above that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 9, 2026: primary completion Aug 2026 → Oct 2026 and completion Aug 2026 → Oct 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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