Stroke, IschemicCHAMPS-TRNCT06479174
Cognitive Strategies for Optimizing Brain Health And Managing Transgenerational Vascular Risk Factors Post-Stroke
A study testing CHAMPS-TR in people with Stroke, Ischemic, run by University of New Mexico at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- CHAMPS-TR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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),
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- 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
Who cannot join
- For all participants:
- not English speaking, reading, and understanding, and
- no access to video-conference software on a computer or smart device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
Suzanne Burns, PhD
About this study
Official title: Cognitive Strategies for Optimizing Brain Health And Managing Transgenerational Vascular Risk Factors Post-Stroke (CHAMPS for Transgenerational Risk)
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.
Read the detailed description
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.
- Conditions
- Stroke, Ischemic
- Being tested
- CHAMPS-TR
- Keywords
- risk reduction, cognition, executive function, cardiometabolic conditions
- Medical subject headings
- Ischemic Stroke, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHAMPS-TRBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| CHAMPS-TR | Experimental | Persons with stroke and a targeted biological family member will receive the CHAMPS intervention including vascular risk reduction coaching and cognitive strategy training. Receives: Behavioral: CHAMPS-TR |
| CHAMPS TR plus remotely supervised transcranial direct current stimulation (RS-tDCS) | Experimental | 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. Receives: Behavioral: CHAMPS-TR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: baseline, up to 7 weeks, and up to 24 weeks
Secondary outcomes (6)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: baseline, up to 7 weeks, and up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start12 Oct 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479174
- Sponsor's protocol ID
- HRRCID 23-332
- Acronym
- CHAMPS-TR
- Status last verified
- Oct 2026
- First submitted
- 14 Jun 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Strategies for Optimizing Brain Health And Managing Transgenerational Vascular Risk Factors Post-Stroke (CHAMPS for Transgenerational Risk)
- ClinicalTrials.gov ID
- NCT06479174
- Acronym / sponsor ID
- CHAMPS-TR / HRRCID 23-332
- Conditions
- Stroke, Ischemic
- Keywords
- risk reduction, cognition, executive function, cardiometabolic conditions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 28 Jun 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CHAMPS-TR | Experimental | Behavioral: CHAMPS-TRPersons with stroke and a targeted biological family member will receive the CHAMPS intervention including vascular risk reduction coaching and cognitive strategy training. |
| CHAMPS TR plus remotely supervised transcranial direct current stimulation (RS-tDCS) | Experimental | Behavioral: CHAMPS-TRPersons 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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),
Key exclusion criteria (3 listed)
- not English speaking, reading, and understanding, and
- no access to video-conference software on a computer or smart device
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 |
|---|---|---|
| CHAMPS-TRPersons 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). | Behavioural | CHAMPS TR plus remotely supervised transcranial direct current stimulation (RS-tDCS), CHAMPS-TR |
Primary outcome
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.
6 secondary outcomes
Oral Trail Making Test Part B
Time frame: baseline and up to 24 weeks
Number Span Test Forward and Backward
Time frame: baseline and up to 24 weeks
Multiple Errands Test Home Version
Time frame: baseline and up to 24 weeks
Mark VCID2 Clinical Cognitive Assessment Battery
Time frame: baseline and up to 24 weeks
PROMIS Self-Efficacy for Managing Medications
Time frame: baseline, up to 7 weeks, and up to 24 weeks
PROMIS Self-Efficacy for Managing Symptoms
Time frame: baseline, up to 7 weeks, and up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: 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
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHAMPS-TR in people with Stroke, Ischemic, run by University of New Mexico 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 17 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Burns, PhD (5052723324, scburns@salud.unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Heart Association Life's Essential 8 Metrics (time frame: baseline, up to 7 weeks, and up to 24 weeks). 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 9 Oct 2026.