Cognitive Strategies for Stroke

(CHAMPS-TR Trial)

Overseen By Suzanne Burns, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of New Mexico

Disqualifiers: Severe aphasia, Dementia, Major anxiety, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new program to reduce stroke risk and boost brain health in stroke survivors and their close family members. The treatment, called CHAMPS-TR, involves virtual sessions with coaching on lowering stroke risk and training on cognitive strategies to improve thinking skills. Stroke survivors and their family members may also receive a type of brain stimulation called RS-tDCS, which aims to enhance brain activity. Potential participants include individuals over 40 who have had an ischemic stroke and experience cognitive difficulties, along with a family member who shares a similar risk profile. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve stroke recovery and brain health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this cognitive strategy training and health coaching program is safe?

Research has shown that the CHAMPS-TR program helps people after a stroke by reducing risk factors and improving brain health. Although specific safety data for CHAMPS-TR alone is limited, the program includes coaching and training generally considered safe.

For CHAMPS-TR with RS-tDCS (a type of brain stimulation), safety reviews indicate that only about 11.62% of studies reported side effects in stroke patients. The most common side effects were mild, such as itching or burning. One study found that tDCS sessions with a current up to 4 mA were safe and well-tolerated in stroke patients.

In summary, the treatments in this trial are generally safe, with most side effects being mild and temporary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CHAMPS-TR treatment for stroke recovery because it combines cognitive strategy training with vascular risk reduction coaching, offering a comprehensive approach to rehabilitation. Unlike standard treatments like physical therapy and medication, CHAMPS-TR also involves a family member, enhancing support and engagement. Additionally, one arm of the trial includes remotely supervised transcranial direct current stimulation (RS-tDCS), a novel brain stimulation method that could boost cognitive recovery. This integrated approach could lead to more effective and faster recovery outcomes for stroke patients.

What evidence suggests that this trial's treatments could be effective for stroke-related cognitive decline?

Research shows that CHAMPS-TR, one of the treatments in this trial, can improve brain health for stroke survivors. This program includes coaching to reduce risks like high blood pressure, which can lead to additional strokes. Studies indicate that addressing these risks can enhance recovery for stroke patients.

For participants receiving CHAMPS-TR along with RS-tDCS (a type of brain stimulation), research has shown promising results. RS-tDCS uses a gentle electrical current to enhance brain function. Specifically, studies found that stroke patients receiving this treatment improved in movement and sensory abilities. This suggests that combining CHAMPS-TR with RS-tDCS may offer extra benefits. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults over 40 who've had an ischemic stroke and show cognitive impairment but don't have severe aphasia, pre-stroke dementia, major anxiety or depression, or recent substance misuse. They need a family member who qualifies to participate and must be able to undergo MRI and RS-tDCS treatments safely.

Inclusion Criteria

I have some cognitive function issues.

I do not have severe difficulty speaking or understanding speech.

I did not have dementia before my stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the CHAMPS-TR intervention including vascular risk reduction coaching and cognitive strategy training, with some receiving additional RS-tDCS

24 weeks

Virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CHAMPS-TR

Trial Overview The study tests a virtual program called CHAMPS-TR that combines cognitive strategy training with health coaching. It aims to reduce vascular risk and improve brain health in people who've had a stroke as well as their biological family members at risk.

How Is the Trial Designed?

Group I: CHAMPS-TR Experimental Treatment 1 Intervention

Persons with stroke and a targeted biological family member will receive the CHAMPS intervention including vascular risk reduction coaching and cognitive strategy training.

Group II: CHAMPS TR plus remotely supervised transcranial direct current stimulation (RS-tDCS) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of New Mexico

Lead Sponsor

Trials

393

Recruited

3,526,000+

Published Research Related to This Trial

Cognitive strategies, particularly motor imagery, have been shown to enhance motor skill acquisition and improve mobility in stroke survivors, based on a review of 26 studies.

General strategy training was found to be more effective than traditional therapy, suggesting that these cognitive approaches could lead to better long-term recovery outcomes for individuals post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive strategy use to enhance motor skill acquisition post-stroke: a critical review. McEwen, SE., Huijbregts, MP., Ryan, JD., et al.[2016]

A cognitive skills remediation program significantly improved thinking skills in acute stroke patients, with the treatment group (16 patients) showing better results than the control group (17 patients) after 3 weeks of targeted retraining.

The program involved personalized sessions focusing on visual scanning, visual-spatial orientation, and time judgment, demonstrating that structured cognitive retraining can enhance recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of cognitive skill remediation in acute stroke patients. Carter, LT., Howard, BE., O'Neil, WA.[2019]

In a study of 39 stroke survivors, computerized cognitive training (CCT) using Lumosity software led to significant improvements in global cognitive function and specific cognitive skills like verbal working memory and processing speed after 12 weeks of training.

While CCT showed immediate cognitive benefits that were maintained for 4 weeks, it did not significantly affect daily activities or participation, and no major differences were found when compared to conventional cognitive training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of computerized cognitive training on cognitive function, activity, and participation in individuals with stroke: A randomized controlled trial. Ho, HY., Chen, MD., Tsai, CC., et al.[2022]

The Multicontext approach in Occupational Therapy significantly improved a 41-year-old stroke patient's self-awareness, strategy use, and functional performance in daily activities, despite no changes in a standard Awareness Questionnaire.

The study highlights that practical awareness during activities may be more crucial for enhancing performance than verbal recognition, demonstrating the Multicontext approach's feasibility in inpatient settings in Argentina.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Multicontext Approach to Improve Instrumental Activities of Daily Living Performance after a Stroke: A Case Report. Nagelkop, ND., Rosselló, M., Aranguren, I., et al.[2021]

Meta-cognitive strategy training, specifically the CO-OP method, was successfully implemented during inpatient rehabilitation for a patient with cognitive impairments after a right hemisphere stroke, showing its feasibility in a clinical setting.

The participant demonstrated significant improvements in rehabilitation engagement and functional independence, with notable increases in performance scores across various measures, suggesting potential benefits of this training approach for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of meta-cognitive strategy training in acute inpatient stroke rehabilitation: case report. Skidmore, ER., Holm, MB., Whyte, EM., et al.[2021]

Out of 1302 analyzed studies on stroke and vascular cognitive impairment (VCI), 49% of stroke studies and 66% of VCI studies reported functional outcome measures, highlighting a significant focus on assessing recovery in preclinical research.

Despite the prevalence of functional assessments, there is considerable inconsistency in the methods used to evaluate and score recovery, suggesting that standardizing these measures could enhance the reliability and applicability of preclinical findings to clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability of functional outcome measures used in animal models of stroke and vascular cognitive impairment - a review of contemporary studies. Hietamies, TM., Ostrowski, C., Pei, Z., et al.[2019]

An umbrella review of 312 studies found that angiotensin-converting enzyme inhibitors (ACEI) and NMDA antagonists, along with therapies like acupuncture and EGB761, can significantly improve cognitive function and daily living activities in stroke survivors with cognitive impairment.

While some treatments showed promise, others like Vinpocetine and Oxiracetam were associated with adverse events or low-quality evidence, highlighting the need for further research to confirm the safety and efficacy of various PSCI therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of post-stroke cognitive impairment therapies: an umbrella review. Li, Y., Cui, R., Liu, S., et al.[2023]

In a study of 44 chronic stroke survivors, adding cognitive strategy training to task-specific training (COSTAR) did not show significant benefits over traditional task-specific training (TST) in improving activity and participation outcomes, despite both groups showing some improvement.

The high attrition rate in the COSTAR group (50%) compared to the TST group (25%) may have influenced the results, suggesting that while cognitive strategies could enhance generalization of skills, their immediate impact on activity performance was not evident in this trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive oriented strategy training augmented rehabilitation (COSTAR) for ischemic stroke: a pilot exploratory randomized controlled study. Wolf, TJ., Doherty, M., Boone, A., et al.[2022]

A pilot study involving 10 adults with stroke-related cognitive impairments showed that strategy training, when added to usual rehabilitation care, is feasible and well-accepted, with high participant retention and satisfaction rates.

Participants who received strategy training demonstrated significantly less disability at six months compared to those who received an attention control session, suggesting that this approach may effectively enhance recovery in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing complex interventions: lessons learned from a pilot study examining strategy training in acute stroke rehabilitation. Skidmore, ER., Dawson, DR., Whyte, EM., et al.[2021]

A qualitative study involving 14 stroke survivors, 11 carers, and 19 healthcare professionals highlighted the importance of tailoring cognitive rehabilitation interventions to the specific needs and preferences of stroke survivors, including considerations of their confidence, fatigue, and cognitive capacity.

Key recommendations for intervention design included incorporating psychoeducation about the effects of stroke, ensuring activities are both individualized and group-based, and addressing practical aspects like the timing and location of the rehabilitation sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I'm just not a Sudoku person": analysis of stroke survivor, carer, and healthcare professional perspectives for the design of a cognitive rehabilitation intervention. Merriman, NA., Bruen, C., Gorman, A., et al.[2021]

A significant number of stroke patients (over one-third) experience vascular-cognitive impairment and/or fatigue, which can severely affect their recovery and long-term outcomes, highlighting the need for effective screening and management.

The updated Canadian Stroke Best Practice Recommendations emphasize the importance of consistent screening for poststroke depression, cognitive impairment, and fatigue, as well as the need for better access to specialists for ongoing care, to improve patient recovery and support caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Canadian Stroke Best Practice Recommendations: Mood, Cognition and Fatigue Following Stroke practice guidelines, update 2015. Eskes, GA., Lanctôt, KL., Herrmann, N., et al.[2022]

The ARTEMIDA study is a 12-month trial involving 500 patients with cognitive impairment after ischaemic stroke, evaluating the efficacy and safety of Actovegin as a treatment for post-stroke cognitive impairment (PSCI).

The study aims to determine if Actovegin can improve cognitive function and whether any benefits are sustained after treatment, using various cognitive assessment scales as primary and secondary outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomised, Double-Blind, Placebo-Controlled Trial of Actovegin in Patients with Post-Stroke Cognitive Impairment: ARTEMIDA Study Design. Guekht, A., Skoog, I., Korczyn, AD., et al.[2021]

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