Cognitive Rehabilitation for Stroke-Related Cognitive Impairment

Overseen By Helen Bliss, HSD

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

Trial Summary

What is the purpose of this trial?

This study will compare two approaches to cognitive rehabilitation in adults with stroke with persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based computer "game" that trains cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. This training is termed Speed of Processing Training (SOPT). One approach will add (A) in-lab training on everyday activities with important cognitive components and (B) procedures designed to transfer improvements in cognition from the treatment setting to everyday life. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will add (A) in-lab training on relaxation, healthy nutrition, and healthy sleep and (B) procedures designed to promote integration of these lifestyle changes into everyday life. This approach is termed Brain Fitness-Heath Education Lifestyle Program (BF-HELP). Both CICT and BF-HELP will involve 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 in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life; The set of the latter procedures is termed the Transfer Package. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. Family caregivers in both groups will also receive training on how to best support participants in their therapeutic program. The study will also test if there is an advantage to placing follow-up phone calls after treatment ends. The purpose of the calls will be to support transition of any behavioral changes achieved during treatment into everyday life on a long-term basis. Participants will be randomly assigned to the interventions. Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6- and 12-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.

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 data supports the effectiveness of the treatment Cognitive Transfer Package and related therapies for stroke-related cognitive impairment?

Research shows that computerized cognitive training can improve cognitive functions in stroke patients, and Speed of Processing Training (SOPT) has been effective in improving everyday functional outcomes in people with multiple sclerosis, suggesting potential benefits for stroke-related cognitive impairment. ^{1 2 3 4 5}

Is cognitive rehabilitation therapy safe for stroke patients?

Research shows that cognitive rehabilitation therapy, including combined aerobic, resistance, and cognitive training, is generally safe for stroke patients. In a study with 131 participants, no serious adverse events related to the intervention were reported. ^{1 5 6 7 8}

How is Speed of Processing Training (SOPT) different from other treatments for stroke-related cognitive impairment?

Speed of Processing Training (SOPT) is unique because it focuses on enhancing the brain's ability to process information quickly, often using computer-based exercises, which is different from traditional therapies that may not specifically target processing speed. This approach can lead to improvements in attention and executive control, which are crucial for daily functioning after a stroke. ^{2 5 9 10 11}

Research Team

Gitendra Uswatte, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 11 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 11 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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. Australia 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The Efficacy of the Speed of Processing Training Program in Improving Functional Outcome: From Restoration to Generalization. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The effects of computer-assisted cognitive rehabilitation on cognitive impairment after stroke: A systematic review and meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Effects of Computer Based Cognitive Rehabilitation in Stroke Patients with Working Memory Impairment: A Systematic Review. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Vascular Cognitive Impairment After Mild Stroke: Connectomic Insights, Neuroimaging, and Knowledge Translation. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Randomized Trial of Combined Aerobic, Resistance, and Cognitive Training to Improve Recovery From Stroke: Feasibility and Safety. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Neurofeedback as a form of cognitive rehabilitation therapy following stroke: A systematic review. [2022]

9. Italy 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. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. [2021]

11. Poland pubmed.ncbi.nlm.nih.gov

PRACTICAL ASPECTS AND RESULTS OF COGNITIVE THERAPY IN THE EARLY RECOVERY PERIOD OF ISCHEMIC STROKE. [2023]