Cognitive Training for Post-Transplant Cognitive Impairment
(cTAG Trial)
Recruiting in Palo Alto (17 mi)
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.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.
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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 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
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
Trials
1677
Patients Recruited
2,458,000+
References
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]Successfully assisting older adults to maintain or improve cognitive function, particularly when they are dealing with neurodegenerative disorders such as Alzheimer's disease (AD), remains a major challenge. Cognitive training may stimulate neuroplasticity thereby increasing cognitive and brain reserve. Commercial brain training programs are computerized, readily-available, easy-to-administer and adaptive but often lack supportive data and their clinical validation literature has not been previously reviewed. Therefore, in this review, we report the characteristics of commercially available brain training programs, critically assess the number and quality of studies evaluating the empirical evidence of these programs for promoting brain health in healthy older adults, and discuss underlying causal mechanisms. We searched PubMed, Google Scholar and each program's website for relevant studies reporting the effects of computerized cognitive training on cognitively healthy older adults. The evidence for each program was assessed via the number and quality (PEDro score) of studies, including Randomized Control Trials (RCTs). Programs with clinical studies were subsequently classified as possessing Level I, II or III evidence. Out of 18 identified programs, 7 programs were investigated in 26 studies including follow-ups. Two programs were identified as possessing Level I evidence, three programs demonstrated Level II evidence and an additional two programs demonstrated Level III evidence. Overall, studies showed generally high methodological quality (average PEDro score = 7.05). Although caution must be taken regarding any potential bias due to selective reporting, current evidence supports that at least some commercially available computerized brain training products can assist in promoting healthy brain aging.
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]The rising prevalence rates of age-related cognitive impairment are a worldwide public concern, bringing about a surge in the number of "brain training" programs commercially available to the general public. Numerous companies advertise that their products improve memory and protect against cognitive decline, though researchers have voiced concerns regarding the validity of such claims. To address this issue, the current meta-analytic investigation examined evidence from 43 studies (encompassing 2,636 participants) to evaluate the efficacy of commercial training programs within two separate populations: healthy older adults and older adults with mild cognitive-impairment (MCI). Seven programs were identified: BrainGymmer, BrainHQ, CogMed, CogniFit, Dakim, Lumosity, and MyBrainTrainer. Analyses yielded small, significant near-transfer effects for both healthy and MCI samples. Far-transfer was not observed for the MCI sample, whereas a small, significant effect was found for subjective but not objective measures of far-transfer in the healthy sample. Analyses of individual domains (combining near-and far-transfer outcomes) yielded significant transfer to executive-functioning, memory, and processing-speed in healthy older adults. After adjusting for publication bias, only the effect size for processing speed remained significant. Transfer to attention, objective everyday functioning, fluid-intelligence, and visuospatial domains was not significant. Thus, whilst "brain training" may be suitable for enjoyment and entertainment purposes, there is currently insufficient empirical evidence to support that such training can improve memory, general cognition, or everyday functioning. This area of research is still in its infancy and warrants further investigation to provide more substantial evidence regarding the efficacy of this rapidly expanding industry.
Feasibility and effectiveness of computerised cognitive training for memory dysfunction following stroke: A series of single case studies. [2021]Computerised cognitive training (CCT) approaches to memory rehabilitation represent an attractive alternative to traditional approaches; however, there is limited empirical evidence to support their use. An AB with follow up single case design was repeated across five participants to explore the feasibility and effectiveness of CCT on subjective memory in patients with stroke. Target behaviour was subjective everyday and prospective memory failures which were assessed weekly. Following baseline (three weeks), participants completed six weeks of LumosityTM training in their homes. Data were analysed visually and statistically. The frequency of prospective memory failures decreased during intervention for one participant, while the frequency of prospective and everyday memory failures decreased significantly during the follow up period for another participant. Yet, significantly more everyday and prospective memory failures were reported following training by one study participant. No significant change in subjective memory ratings was found for remaining participants. Regarding secondary outcomes, meaningful changes on objective measures of memory were not observed, despite considerable inter-individual variability. Three participants reported improvement in individualised memory goals, while two participants described a decline. Overall, LumosityTM training appears feasible; however, no consistent evidence to support effectiveness of this CCT on subjective or objective memory was found.
The effects of an 8-week computer-based brain training programme on cognitive functioning, QoL and self-efficacy after stroke. [2017]Cognitive impairment after stroke has a direct impact on daily functioning and quality of life (QoL) of patients and is associated with higher mortality and healthcare costs. The aim of this study was to determine the effect of a computer-based brain training programme on cognitive functioning, QoL and self-efficacy compared to a control condition in stroke patients. Stroke patients with self-perceived cognitive impairment were randomly allocated to the intervention or control group. The intervention consisted of an 8-week brain training programme (Lumosity Inc.®). The control group received general information about the brain weekly. Assessments consisted of a set of neuropsychological tests and questionnaires. In addition, adherence with trained computer tasks was recorded. No effect of the training was found on cognitive functioning, QoL or self-efficacy when compared to the control condition, except for very limited effects on working memory and speed. This study found very limited effects on neuropsychological tests that were closely related to trained computer tasks, but no transfers to other tests or self-perceived cognitive failures, QoL or self-efficacy. These findings warrant the need for further research into the value of computer-based brain training to improve cognitive functioning in the chronic phase after stroke.
Feasibility and Tolerability of a Culture-Based Virtual Reality (VR) Training Program in Patients with Mild Cognitive Impairment: A Randomized Controlled Pilot Study. [2020]The present study examined whether a culture-based virtual reality (VR) training program is feasible and tolerable for patients with amnestic mild cognitive impairment (aMCI), and whether it could improve cognitive function in these patients. Twenty-one outpatients with aMCI were randomized to either the VR-based training group or the control group in a 1∶1 ratio. The VR-based training group participated in training for 30 min/day, two days/week, for three months (24 times). The VR-based program was designed based on Korean traditional culture and used attention, processing speed, executive function and memory conditions to stimulate cognitive function. The adherence to the culture-based VR training program was 91.55% ± 6.41% in the VR group. The only adverse events observed in the VR group were dizziness (4.2%) and fatigue (8.3%). Analysis revealed that the VR-based training group exhibited no significant differences following the three-month VR program in Korean Mini-Mental State Examination (K-MMSE) scores, working memory functions such as performance on the digit span test, or in Stroop test performance and word fluency. We conclude that although the 12-week culture-based VR training program did not improve cognitive function, our findings revealed that the culture-based VR training program was feasible and tolerable for participants with aMCI.
Long-term cognitive impairments in kidney transplant recipients: impact on participation and quality of life. [2023]Cognitive impairment is often present shortly after transplantation in kidney transplant recipients (KTR). To date, it is unknown whether these impairments persist in thelong term, to what extent they are associated with disease-related variables and whether they affect societal participation and quality of life (QoL) of KTR.
Discrepancies between Perceived and Measured Cognition in Kidney Transplant Recipients: Implications for Clinical Management. [2022]Cognitive impairment is common in kidney transplant (KT) recipients and affects quality of life, graft survival, morbidity, and mortality. Failure to identify patients with cognitive impairment can withhold appropriate and timely intervention. This study determines whether measured cognition with standard screening tools offers any advantage over perceived cognition in screening transplant patients for cognitive impairment.
Current recommendations regarding evaluation of cognitive functioning in organ transplant candidates. [2023]Cognitive impairment is associated with negative effects on solid organ transplant candidates, recipients, and their care partners. However, because of the heterogeneity of mechanisms, presentations, and assessment measures, research suggests a wide array of impairments, patterns of impairments, and unclear trajectories posttransplant. This review provides an abbreviated synthesis of recent research on cognitive impairments observed in organ-eligible candidates and potential trajectories through posttransplant, current clinical recommendations regarding integration of assessment into routine clinical transplant practice, as well as recommendations for future research.
Cognitive Function in Kidney Transplantation. [2022]Cognitive impairment is common in kidney transplant recipients and affects quality of life, graft survival, morbidity, and mortality. In this review article we discuss the epidemiology, diagnosis, pathophysiology and future directions for cognitive impairment in kidney transplantation. We describe the potential role of pre-transplant cognition, immunosuppression and peri-transplant factors in post -transplant cognitive impairment.
Prevalence and Correlates of Cognitive Impairment in Kidney Transplant Patients Using the DemTect-Results of a KTx360 Substudy. [2020]Cognitive impairment in kidney transplantation (KTx) patients is associated with allograft survival and mortality. However, the prevalence of cognitive impairment after KTx is still understudied. Thus, we aimed to assess the prevalence of cognitive impairment in KTx patients and to identify sociodemographic, medical, donation-specific, and psychological variables associated with cognitive impairment. In this cross-sectional two-center study, 583 KTx patients participated in a structured post-transplant care program. The DemTect was used to assess cognition, and cognitive impairment was defined as a score of < 13. Mean age was 52.11 years, 59% were male, 27.4% had ≥12 years of school attendance, and 85.9% had hypertension. The prevalence of cognitive impairment was 15.6%. Cognitive impairment was significantly associated with higher age, male sex, lower educational level, subjective perception of cognitive decline, higher rates of hypertension, lower kidney functioning, and obesity (BMI > 30 kg/m2). Using logistic regression analysis, all variables except age remained significant. Our results suggest that cognitive impairment affects a significant number of patients after KTx. Transplant centers may consider screening for cognitive impairment using objective tests, especially in patients with a high-risk profile. Furthermore, studies with longitudinal designs are required in order to assess moderators and mediators for cognitive trajectories.