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

NCT06479174 | Recruiting

• 1 other identifier: HRRCID 23-332
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

risk reduction; cognition; executive function; cardiometabolic conditions

Outcome Measures

Primary Outcomes (2)

• 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

  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.

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

Secondary Outcomes (6)

• Oral Trail Making Test Part B

  baseline and up to 24 weeks

• Number Span Test Forward and Backward

  baseline and up to 24 weeks

• Multiple Errands Test Home Version

  baseline and up to 24 weeks

• Mark VCID2 Clinical Cognitive Assessment Battery

  baseline and up to 24 weeks

• PROMIS Self-Efficacy for Managing Medications

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

Study Arms (2)

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.

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.

Behavioral: CHAMPS-TR

Interventions

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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• For all participants:
• not English speaking, reading, and understanding, and
• no access to video-conference software on a computer or smart device

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Central Study Contacts

Suzanne Burns, PhD

CONTACT

5052723324; scburns@salud.unm.edu

Tim Dionne, PhD

CONTACT

5052720639; tdionne@salud.unm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 28, 2024
• Study Start: October 12, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)