Cognitive Training for Post-Transplant Cognitive Impairment

(cTAG Trial)

Overseen By Noha M Sharafeldin, MD,MSc, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Neurological, Psychiatric, Sensory impairments, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a brain-training program called Lumosity can improve memory and thinking skills in individuals who have undergone a blood stem cell transplant. It also examines participants' interest in learning about their genetic risk for cognitive issues post-transplant. Two groups participate: one begins the Lumosity program immediately, while the other starts after three months. Eligible participants must have had a stem cell transplant at least three months prior, be in outpatient care, and have internet access. Participants should not have major neurological or psychiatric issues or have recently participated in a similar brain-training program. As an unphased trial, this study offers a unique opportunity to contribute to understanding cognitive recovery after stem cell transplants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Lumosity program is safe for improving neurocognitive function in HCT survivors?

Research has shown that Lumosity, a brain training program, is generally safe for use. In past studies, participants engaged in various games and exercises on Lumosity to train their brains. These studies have not identified any major negative side effects from using the program.

For instance, one study tested Lumosity and found it helped maintain thinking skills without harming participants. Another study suggested that playing brain games like those in Lumosity might help slow mental decline in some areas, again without causing major problems.

Overall, the evidence indicates that Lumosity is well-tolerated by users. Participants in these studies did not report any serious issues from using the program. This suggests that Lumosity is a safe choice for those looking to improve or maintain their mental abilities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Lumosity for post-transplant cognitive impairment because it offers a non-pharmacological approach to improving cognitive function. Unlike standard treatments that may focus on medication to manage symptoms, Lumosity is a brain-training program that uses engaging games and exercises to potentially enhance memory, attention, and problem-solving skills. This method is appealing because it is user-friendly, accessible from home, and can be tailored to individual cognitive needs, providing a personalized experience that traditional treatments may lack.

What evidence suggests that the Lumosity program is effective for improving neurocognitive function in HCT survivors?

Research shows that brain training programs like Lumosity can enhance brain function. Studies have found that these computer-based exercises can slow mental decline, keeping the brain sharp. In similar situations, such as surgery, brain training has reduced issues like confusion and memory loss shortly after the operation. In this trial, one group of participants will begin the Lumosity program at enrollment, while another group will start three months later. Although specific data for hematopoietic cell transplantation (HCT) survivors is limited, these findings suggest that Lumosity might also improve brain function in HCT survivors. ^{2 6 7 8 9}

Who Is on the Research Team?

Noha Sharafeldin, MD, MSc, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults over 21 who had a bone marrow transplant at UAB, are 3-6 months post-transplant, and can use an internet-connected computer. It's not for those with neurological or major psychiatric disorders, significant sensory/motor issues, color blindness, or recent neuropsychological intervention.

Inclusion Criteria

Possess access to an internet-connected home computer

I am 3 to 6 months post bone marrow transplant and not hospitalized.

I am 21 years or older and had a stem cell transplant at UAB.

Exclusion Criteria

I have a history of color blindness.

I do not have a major neurological or psychiatric disorder, or significant hearing, vision, or movement issues.

You have received help from a mental health professional in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in daily cognitive training using the Lumosity program for 12 weeks

12 weeks

Daily online sessions

Follow-up

Participants are monitored for changes in cognitive function and attitudes towards genetic information

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lumosity

Trial Overview The study tests if the Lumosity cognitive training program helps improve brain function in people who've had a bone marrow transplant. Participants will either start training right away or be placed on a waitlist (control group) to compare results.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The arm will begin the Lumosity program at enrollment in the study.

Group II: Wait List Control Active Control 1 Intervention

The arm will begin the Lumosity program 3 months after enrollment in the study.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

In a study of 157 kidney transplant recipients, objective cognitive assessment using the Montreal Cognitive Assessment (MoCA) was found to be more reliable than clinical perceptions from physicians and nurses in identifying cognitive impairment.

The study revealed that clinical perceptions had low accuracy, with only 66% sensitivity for physicians and 65% for nurses in detecting cognitive impairment, highlighting the need for standardized cognitive screening tools in transplant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discrepancies between Perceived and Measured Cognition in Kidney Transplant Recipients: Implications for Clinical Management. Gupta, A., Thomas, TS., Klein, JA., et al.[2022]

Cognitive impairments are common in organ transplant candidates and recipients, with some patients, especially frail individuals, continuing to experience these issues even after transplantation, indicating a need for ongoing assessment.

New assessment tools for cognitive impairments, particularly in liver transplant candidates, show promise for integration into clinical practice, but further research is needed to establish effective assessment and intervention strategies post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current recommendations regarding evaluation of cognitive functioning in organ transplant candidates. Jesse, MT., Haver, DB.[2023]

The culture-based virtual reality (VR) training program was found to be feasible and well-tolerated by patients with amnestic mild cognitive impairment (aMCI), with a high adherence rate of 91.55%.

Despite the program's feasibility, it did not lead to significant improvements in cognitive function as measured by various tests, including the Korean Mini-Mental State Examination and working memory assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Tolerability of a Culture-Based Virtual Reality (VR) Training Program in Patients with Mild Cognitive Impairment: A Randomized Controlled Pilot Study. Park, JH., Liao, Y., Kim, DR., et al.[2020]

A meta-analysis of 43 studies involving 2,636 participants found that commercial brain training programs showed small but significant improvements in near-transfer effects for both healthy older adults and those with mild cognitive impairment (MCI).

However, there was no evidence of far-transfer benefits for MCI participants, and only limited improvements in processing speed for healthy adults, indicating that while brain training may be enjoyable, it lacks strong empirical support for enhancing memory or overall cognitive function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Game a Day Keeps Cognitive Decline Away? A Systematic Review and Meta-Analysis of Commercially-Available Brain Training Programs in Healthy and Cognitively Impaired Older Adults. Nguyen, L., Murphy, K., Andrews, G.[2022]

An 8-week computer-based brain training program did not significantly improve cognitive functioning, quality of life, or self-efficacy in stroke patients compared to a control group, although there were minor improvements in working memory and speed.

The study highlights the limited effectiveness of such brain training interventions in enhancing cognitive abilities after stroke, suggesting that more research is needed to explore their potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of an 8-week computer-based brain training programme on cognitive functioning, QoL and self-efficacy after stroke. Wentink, MM., Berger, MA., de Kloet, AJ., et al.[2017]

Cognitive impairment is prevalent among kidney transplant recipients, significantly impacting their quality of life, graft survival, and overall health outcomes.

Identifying and addressing cognitive impairment before and after transplantation is crucial, as it can influence patient care and the effectiveness of interventions aimed at improving post-transplant outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Function in Kidney Transplantation. Jurgensen, A., Qannus, AA., Gupta, A.[2022]

Computerized cognitive training (CCT) using LumosityTM showed feasibility for memory rehabilitation in stroke patients, with some participants reporting fewer memory failures during the intervention.

However, the study found no consistent evidence of effectiveness, as most participants did not show significant changes in subjective or objective memory measures, highlighting the variability in individual responses to the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of computerised cognitive training for memory dysfunction following stroke: A series of single case studies. Withiel, TD., Wong, D., Ponsford, JL., et al.[2021]

Kidney transplant recipients (KTR) show significant long-term cognitive impairments, particularly in memory, mental speed, and executive functioning, compared to healthy controls, with 16% of KTR meeting criteria for mild cognitive impairment (MCI).

These cognitive impairments are not linked to age or disease-related factors but are associated with lower societal participation and quality of life, highlighting the need for neuropsychological assessments in KTR to address these issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term cognitive impairments in kidney transplant recipients: impact on participation and quality of life. Ziengs, AL., Buunk, AM., van Sonderen, L., et al.[2023]

In a study of 583 kidney transplant patients, 15.6% were found to have cognitive impairment, highlighting a significant issue in post-transplant care.

Cognitive impairment was linked to factors such as older age, male sex, lower education levels, hypertension, and obesity, suggesting that transplant centers should consider screening for cognitive issues, especially in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and Correlates of Cognitive Impairment in Kidney Transplant Patients Using the DemTect-Results of a KTx360 Substudy. Nöhre, M., Bauer-Hohmann, M., Klewitz, F., et al.[2020]

A review of 18 commercially available brain training programs found that 7 of them were studied in 26 high-quality trials, with two programs showing strong Level I evidence for promoting cognitive health in older adults.

The overall methodological quality of the studies was high, suggesting that some computerized cognitive training programs can effectively support healthy brain aging, although caution is advised due to potential biases in reporting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Cognitive Functioning in Healthly Older Adults: a Systematic Review of the Clinical Significance of Commercially Available Computerized Cognitive Training in Preventing Cognitive Decline. Shah, TM., Weinborn, M., Verdile, G., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-hematologic-neoplasms-7-2017-9bd8e

Cognitive Training for Post-Transplant Cognitive Impairment Trial Overview The study tests if the Lumosity cognitive training program helps improve brain function in people who've had a bone marrow transplant.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7614332/

The effects of computerised cognitive training on post-CABG ... In pre-operative settings (non-cardiac patients), cognitive training has significantly reduced cognitive decline (1-week post-operatively)19 and delirium ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05708716

Diet and Cognitive Training in Hematologic Cancer Survivors The goal of this clinical trial is to examine feasibility of a cognitive intervention program in blood cancer survivors. The main questions it aims to ...

4. lumosity.com lumosity.com/hcp/research/completed

Published Papers - HCP Below you'll find abstracts from published papers from our team and HCP collaborators, including observational studies regarding trends in Lumosity data.

5. cognitivetrainingdata.org cognitivetrainingdata.org/studies-cognitive-training-benefits/

Published Papers This is a partial list of studies that directly demonstrate that computerized cognitive training can improve cognition.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4396447/

A randomized controlled trial of brain training with non- ... This randomized controlled study (ClinicalTrials.gov NCT02007616) investigated the maintenance of training effects of 20 1-hr non-action video game training ...

7. apa.org apa.org/monitor/2016/09/jn

'Brain games': Helpful tool or false promise? According to the company's literature, Lumosity offers a "personalized brain training program" and related assessment measures, as well as ...

8. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-020-02041-y

Interventions Made to Preserve Cognitive Function Trial ... Intradialytic CT consists of playing brain games through Lumosity®, which is a web-based cognitive training program on a tablet PC for at least ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5762950/

Intradialytic Cognitive and Exercise Training May Preserve ... Preliminary findings of our pilot study suggested that cognitive decline in psychomotor speed and executive function is possibly prevented by intradialytic CT ...