Cognitive Rehabilitation for Stroke-Related Cognitive Impairment

Overseen By Helen Bliss, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Developmental disability, Psychiatric disorder, Substance abuse, others

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

Compensation: Varies

Number of Visits: 15

Duration: 2-4 weeks

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to assist individuals who have had a stroke and continue to experience mild to moderate cognitive issues. Both methods use a computer game to enhance the brain's information processing speed. One method adds training for everyday skills, while the other emphasizes lifestyle changes such as relaxation and healthy habits. Some participants will also receive follow-up phone calls to support improvements in daily life. This trial suits adults who had a stroke more than three months ago and struggle with everyday tasks due to cognitive issues. As an unphased trial, it offers a unique opportunity to explore innovative methods that could enhance daily living skills and cognitive function.

Do I need to stop my current medications for this trial?

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 these cognitive rehabilitation approaches are safe for stroke-related cognitive impairment?

Research shows that both treatments under study—CICT and BF-HELP—are promising in terms of safety.

For CICT, studies have found positive effects on thinking skills. In one trial with 16 participants, improvements in both mental abilities and daily activities suggested CICT is safe and effective. Another study demonstrated that combining CICT with standard rehabilitation led to better results, indicating it's generally safe when used with other treatments.

For BF-HELP, structured lifestyle programs have been linked to significant improvements in thinking skills in older adults. These programs focus on relaxation, nutrition, and sleep, and are designed to be safe and helpful, especially for those at risk of mental decline.

Overall, both approaches appear safe for people with stroke-related thinking issues. Strong evidence indicates they are well-tolerated and offer real benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cognitive rehabilitation approaches being tested for stroke-related cognitive impairment because they combine both at-home and in-lab training, which is a unique blend compared to traditional cognitive therapies. These protocols emphasize Speed of Processing Training (SOPT), which aims to enhance brain processing speed—a critical aspect of recovery that's often overlooked in standard treatments. Additionally, the inclusion of follow-up phone calls in some groups is designed to help participants incorporate their gains into daily life, potentially leading to longer-lasting improvements. This holistic approach, targeting not just cognitive skills but also lifestyle factors like nutrition and sleep, could offer a more comprehensive recovery pathway for stroke survivors.

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

Research has shown that Speed of Processing Training (SOPT), included in all treatment arms of this trial, can enhance the brain's information processing speed after a stroke. Participants may receive the CICT method, which studies suggest significantly boosts both thinking speed and everyday skills. One study found that participants increased their processing speed by an average of 64%.

Alternatively, participants may receive the BF-HELP method, which incorporates lifestyle changes to support brain recovery after a stroke. Some evidence indicates that activities like exercise can improve thinking abilities, though data remains limited.

In summary, both CICT and BF-HELP offer benefits in different ways: CICT focuses on brain exercises, while BF-HELP emphasizes lifestyle changes. ^{3 6 7 8 9}

Who Is on the Research Team?

Gitendra Uswatte, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

Adults over 40 with mild to moderate cognitive impairment from a stroke that happened more than a year ago. They need to be medically stable, able to follow instructions, and have adequate sight and hearing. A caregiver must be available, and they should be capable of traveling to the lab multiple times.

Inclusion Criteria

I am physically and mentally fit to participate in the study.

You have some trouble with thinking and memory, as shown by a score of 10-26 on a test called the Montreal Cognitive Assessment.

You live at home, not in a hospital or nursing facility.

Exclusion Criteria

I have cognitive issues due to a condition like Alzheimer's, brain injury, or substance abuse.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive 35 hours of training, including Speed of Processing Training (SOPT) and either Constraint-Induced Cognitive Therapy (CICT) or Brain Fitness-Health Education Lifestyle Program (BF-HELP).

2-4 weeks

10 in-home sessions, 10 in-lab sessions

Follow-up

Participants are monitored for transition of behavioral changes into everyday life, with follow-up phone calls for some groups.

12 months

4 weekly calls, then monthly calls for 11 months

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Transfer Package
• Family Caregiver Coaching
• Follow-up Phone Calls
• Healthy Lifestyle In-lab Training
• Healthy Lifestyle Transfer Package
• Instrumental Activities of Daily Living In-lab Training
• Speed of Processing Training

Trial Overview

The trial compares two cognitive rehabilitation methods for post-stroke patients: Constraint-Induced Cognitive Therapy (CICT) which includes in-lab training on daily activities, and Brain Fitness-Health Education Lifestyle Program (BF-HELP), focusing on relaxation and healthy lifestyle integration.

How Is the Trial Designed?

Group I: CICT without Follow-up Phone Calls Experimental Treatment 4 Interventions

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) shaping on IADL and (B) the Cognitive Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. No follow-up phone calls will be made after treatment ends.

Group II: CICT with Follow-up Phone Calls Experimental Treatment 5 Interventions

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) shaping on IADL and (B) the Cognitive Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 5 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.

Group III: BF-HELP with Follow-up Phone Calls Active Control 5 Interventions

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) training on relaxation, healthy nutrition, and healthy sleep, and (B) the Healthy Lifestyle Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 5 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.

Group IV: BF-HELP without Follow-up Phone Calls Active Control 5 Interventions

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) training on relaxation, healthy nutrition, and healthy sleep, and (B) the Healthy Lifestyle Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. No follow-up phone calls will be made after treatment ends.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Posit Science

Collaborator

Trials

2

Recruited

120+

Published Research Related to This Trial

Intensive rehabilitation training significantly improved attention and executive control in 12 patients with acquired brain injuries, demonstrating the potential for targeted interventions to enhance cognitive functions.

Functional MRI results indicated that the training enhanced neural modulation in the extrastriate cortex and influenced prefrontal cortex activity, suggesting that these neural changes are linked to the observed behavioral improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Chen, AJ., Novakovic-Agopian, T., Nycum, TJ., et al.[2021]

A meta-analysis of 17 studies involving 622 stroke patients found that computerized cognitive training significantly enhances cognitive functions such as global cognition, working memory, attention, and executive function.

Despite these cognitive improvements, the training did not show significant effects on patients' daily living activities or depression, indicating that while cognitive training is beneficial, its impact on overall quality of life needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of computerized cognitive training on improving cognitive functions of stroke patients: A systematic review and meta-analysis of randomized controlled trials. Zhou, Y., Feng, H., Li, G., et al.[2022]

The combined aerobic, resistance, and cognitive training intervention (CARET+CTI) after stroke was found to be safe and feasible, with a higher adherence rate (74%) compared to the control group (54%), indicating that participants were more likely to stick with the program.

While the CARET+CTI group showed greater improvements in physical, cognitive, and mood outcomes compared to the control group, these results were not statistically significant after adjustments, suggesting further research is needed to confirm the effectiveness of this multifaceted approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety. Koch, S., Tiozzo, E., Simonetto, M., et al.[2021]

A systematic review of 32 studies with 1837 participants found that computer-assisted cognitive rehabilitation significantly improved cognitive function in post-stroke patients compared to conventional therapy alone, as measured by various cognitive assessments (p < .01).

The addition of computer-assisted cognitive rehabilitation also enhanced patients' activities of daily living, indicating its effectiveness in restoring overall functional abilities after a stroke (p < .05).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of computer-assisted cognitive rehabilitation on cognitive impairment after stroke: A systematic review and meta-analysis. Nie, P., Liu, F., Lin, S., et al.[2022]

Cognitive training significantly improves cognitive function recovery in patients who have experienced an ischemic stroke, as indicated by increased scores on the Montreal Cognitive Assessment Scale (MoCA) in a study of 108 patients followed for 1 to 3 months post-stroke.

The study suggests that comprehensive rehabilitation measures, including cognitive training, enhance the quality of life for stroke patients during their early recovery period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRACTICAL ASPECTS AND RESULTS OF COGNITIVE THERAPY IN THE EARLY RECOVERY PERIOD OF ISCHEMIC STROKE. Morozova, OG., Kosheleva, AN., Fedak, BS., et al.[2023]

In a study involving 80 stroke patients, 4 weeks of online adaptive attention training (SAT) led to significant improvements in everyday functioning, particularly for those with spatial impairments, compared to working memory training and a waitlist group.

While no significant changes were observed in cognitive test performance, the positive patient-reported outcomes suggest that SAT may be a valuable low-cost adjunct to rehabilitation services for enhancing daily life after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized control trial of the effects of home-based online attention training and working memory training on cognition and everyday function in a community stroke sample. Peers, PV., Punton, SF., Murphy, FC., et al.[2023]

Neurofeedback therapy (NFT) shows promise in improving cognitive deficits in stroke patients, with most of the eight studies reviewed reporting positive outcomes after therapy initiation.

However, the overall quality of the studies was limited, which affects the reliability of the findings, highlighting the need for better-designed research and standardized NFT protocols to fully understand its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback as a form of cognitive rehabilitation therapy following stroke: A systematic review. Renton, T., Tibbles, A., Topolovec-Vranic, J.[2022]

A systematic review of computer-based cognitive rehabilitation (CBCR) for working memory impairment after stroke found insufficient evidence to determine its effectiveness, as studies showed highly variable results and used different measures of working memory.

No harmful effects were reported from CBCR interventions, but the lack of meaningful differences in working memory improvement compared to control groups suggests that more research is needed to assess its true benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Computer Based Cognitive Rehabilitation in Stroke Patients with Working Memory Impairment: A Systematic Review. Niemeijer, M., Sværke, KW., Christensen, HK.[2020]

Current stroke assessment methods struggle to identify vascular cognitive impairment (VCI), particularly in cases of mild stroke (MiS), which can lead to reduced processing speed and cognitive function.

Using processing speed as a screening tool for VCI can improve detection sensitivity and specificity, guiding rehabilitation strategies and enhancing patient recovery by addressing disruptions in neural networks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular Cognitive Impairment After Mild Stroke: Connectomic Insights, Neuroimaging, and Knowledge Translation. Holguin, JA., Margetis, JL., Narayan, A., et al.[2022]

Rehabilitation training significantly improved cognitive function and motor skills in 100 patients recovering from a cerebrovascular accident, as evidenced by higher scores on cognitive assessment scales and increased levels of neuroprotective factors like BDNF after 6 months.

The study suggests that rehabilitation training may work by reducing neurotoxic and pro-inflammatory factors while enhancing neurotrophic factors, potentially through the JNK signaling pathway, which helps prevent cell apoptosis and supports cognitive recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation training improves cognitive disorder after cerebrovascular accident by improving BDNF Bcl-2 and Bax expressions in regulating the JMK pathway. Wang, HY., Zhu, CH., Liu, DS., et al.[2022]

In a randomized controlled trial with 60 participants with multiple sclerosis, Speed of Processing Training (SOPT) led to significant improvements in everyday functional outcomes, specifically in the Timed Instrumental Activities of Daily Living (TIADL) scores compared to an active control group.

While SOPT improved cognitive performance in some participants, it did not result in overall changes in quality of life or self-reported functional status, indicating that while cognitive training can enhance certain skills, it may not fully translate to broader functional improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of the Speed of Processing Training Program in Improving Functional Outcome: From Restoration to Generalization. Goverover, Y., Costa, S., DeLuca, J., et al.[2023]

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