Recruiting

Cognitive Strategies

Sponsor:

University of New Mexico

Code:

NCT06479174

Conditions

Stroke, Ischemic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

CHAMPS-TR

Study Details

Brief 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. 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.

Conditions

Stroke, Ischemic

Study ID

NCT06479174

Start date

Oct 12, 2023

Status verified date

Jul, 2026

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Aug 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. primary diagnosis of acute ischemic stroke,
2. impairment of cognitive function (score >1 on Quick Executive Interview - telephone screener),
3. absence of severe aphasia (score of 0 or 1 on NIH Stroke Scale),
4. absence of pre-stroke dementia (client report),
5. absence of major anxiety and depressive disorder (PHQ-9, GAD-7),
6. absence of drug and alcohol misuse within 3 months of study (AUDIT, DAST),
7. greater than 40 years of age,
8. having a potential family member who meets targeted family member criteria,
9. 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:

1. a minimum of 18 years of age,
2. biological kin of person with stroke,
3. absence of dementia (client report),
4. absence of major anxiety and depressive disorder (PHQ-9, GAD-7),
5. absence of drug and alcohol misuse within 3 months of study (AUDIT, DAST),
6. greater than 18 years of age, and
7. having a sibling or parent who had an ischemic stroke

Exclusion Criteria:

For all participants:

1. not English speaking, reading, and understanding, and
2. no access to video-conference software on a computer or smart device

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: CHAMPS TR plus remotely supervised transcranial direct current stimulation (RS-tDCS)

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.

Interventions

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 measure

  • American Heart Association Life's Essential 8 Metrics [ Time Frame: baseline, up to 7 weeks, and up to 24 weeks ]
  • Cardiovascular risk factors, Aging, and Incidence of Dementia (CAIDE) [ Time Frame: baseline, up to 7 weeks, and up to 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of New Mexico Health Sciences Center

Recruiting

Albuquerque, New Mexico, United States, 87131

More Information

Sponsor

University of New Mexico

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • risk reduction
  • cognition
  • executive function
  • cardiometabolic conditions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of New Mexico on 2026-07-30.