60 Participants Needed

Cognitive Training for Post-Transplant Cognitive Impairment

(cTAG Trial)

LH
NM
Overseen ByNoha M Sharafeldin, MD,MSc, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

A pilot study to evaluate feasibility of enrollment of patients in an intervention to improve neurocognitive function in hematopoietic cell transplantation (HCT) survivors using the cognitive training Lumosity program. In addition, patients' interest in receiving information regarding genetic risk of cognitive impairment post-HCT will be measured.

Will I have to stop taking my current medications?

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

Is the Lumosity Cognitive Training Program safe for humans?

The Lumosity Cognitive Training Program appears to be safe for humans, as studies have not reported any significant adverse effects related to its use. However, one study on a similar virtual reality training program noted minor issues like dizziness and fatigue in a small percentage of participants.12345

How does cognitive training differ from other treatments for post-transplant cognitive impairment?

Cognitive training is unique because it focuses on improving mental processes through exercises and activities, rather than using medication or other medical interventions. This approach is particularly novel for post-transplant cognitive impairment, where standard treatments are not well-established.678910

Research Team

NM

Noha Sharafeldin, MD, MSc, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.
See 1 more

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

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

Treatment Details

Interventions

  • Lumosity
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
The arm will begin the Lumosity program at enrollment in the study.
Group II: Wait List ControlActive Control1 Intervention
The arm will begin the Lumosity program 3 months after enrollment in the study.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Findings from Research

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.
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]
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.
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]
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.
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]

References

The effects of an 8-week computer-based brain training programme on cognitive functioning, QoL and self-efficacy after stroke. [2017]
Enhancing Cognitive Functioning in Healthly Older Adults: a Systematic Review of the Clinical Significance of Commercially Available Computerized Cognitive Training in Preventing Cognitive Decline. [2018]
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. [2022]
Feasibility and effectiveness of computerised cognitive training for memory dysfunction following stroke: A series of single case studies. [2021]
Feasibility and Tolerability of a Culture-Based Virtual Reality (VR) Training Program in Patients with Mild Cognitive Impairment: A Randomized Controlled Pilot Study. [2020]
Cognitive Function in Kidney Transplantation. [2022]
Long-term cognitive impairments in kidney transplant recipients: impact on participation and quality of life. [2023]
Discrepancies between Perceived and Measured Cognition in Kidney Transplant Recipients: Implications for Clinical Management. [2022]
Current recommendations regarding evaluation of cognitive functioning in organ transplant candidates. [2023]
Prevalence and Correlates of Cognitive Impairment in Kidney Transplant Patients Using the DemTect-Results of a KTx360 Substudy. [2020]