Cognitive Training for Post-Transplant Cognitive Impairment

(cTAG Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Noha Sharafeldin, MD, MSc, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: Neurological, Psychiatric, Sensory impairments, others

No Placebo Group

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

Research Team

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.

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.

Trial 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 (Behavioral Intervention)

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.

Participant Groups

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+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2018]

2. United States 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of computerised cognitive training for memory dysfunction following stroke: A series of single case studies. [2021]

4. England 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. [2017]

5. Switzerland 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. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Long-term cognitive impairments in kidney transplant recipients: impact on participation and quality of life. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Discrepancies between Perceived and Measured Cognition in Kidney Transplant Recipients: Implications for Clinical Management. [2022]

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

Current recommendations regarding evaluation of cognitive functioning in organ transplant candidates. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Function in Kidney Transplantation. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Prevalence and Correlates of Cognitive Impairment in Kidney Transplant Patients Using the DemTect-Results of a KTx360 Substudy. [2020]