Digital Cognitive Rehabilitation for Sickle Cell Disease

(ALL IN Trial)

Recruiting at 1 trial location

Overseen By Sara Ropeta, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's National Research Institute

Must not be taking: Stimulants

Disqualifiers: Motor impairment, Mental health condition, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5-8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Cogmed+, which combines digital memory training and social support to help children with sickle cell disease improve their working memory. The trial aims to determine if this approach is practical and can be used daily by patients. Children and teens, ages 7-16, who have sickle cell disease and struggle with memory tasks may be suitable for this study. As an unphased trial, it offers a unique opportunity to explore innovative ways to enhance memory in young patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you recently started or changed the dose of a stimulant medication for attention problems, you might not be eligible to participate.

What prior data suggests that this digital cognitive rehabilitation is safe for youth with sickle cell disease?

Research on digital cognitive rehabilitation tools like Cogmed+ lacks specific safety data for humans. However, tests have assessed its usability and user satisfaction. Cogmed+ aims to improve memory skills through digital exercises. As it doesn't involve medication, it is generally considered safe and easy to use. No reports of harmful side effects have emerged, which is encouraging for potential trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for cognitive issues in sickle cell disease, which often includes medications and cognitive therapy, Cogmed+ offers a digital approach. This treatment is unique because it provides home-based cognitive rehabilitation and memory strategy training specifically targeting working memory. Researchers are excited about Cogmed+ because it allows patients to engage with their treatment in the comfort of their own homes and is tailored to improve specific cognitive functions impacted by sickle cell disease. By utilizing a digital platform, it could offer more flexibility and accessibility than traditional methods.

What evidence suggests that this digital cognitive rehabilitation is effective for sickle cell disease?

Research has shown that Cogmed, a digital training program, may improve memory in young people with sickle cell disease (SCD). This trial will evaluate Cogmed+, an enhanced version of the program, as a home-based digital cognitive rehabilitation and memory strategy training targeting working memory functioning. Studies have examined the ease of use of Cogmed at home for children with SCD. Early results suggest that Cogmed can enhance memory skills, which are often challenging for these children. The program aims to improve daily life by training the brain to better hold and manage information, which is particularly useful for boosting attention and memory in young people with SCD. ^{1 6 7 8 9}

Who Is on the Research Team?

Steven Hardy, PhD

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

This trial is for young people aged 7-16 with sickle cell disease who have working memory challenges. They must be able to use a computer and speak English well, without recent changes in attention disorder medication or mental health conditions that would interfere with the study.

Inclusion Criteria

I have been diagnosed with sickle cell disease.

Patients will only enter the treatment phase if they score >1 SD below the normative mean on at least one standardized working memory assessment (i.e., Digit Span or Spatial Span subtests) or demonstrate a relative weakness in working memory (>1 SD below the estimated IQ)

I am between 7 and 16 years old.

Exclusion Criteria

Motor, visual, or auditory impairment that prevents computer use

History of photosensitive seizures

I have a mental health condition that needs treatment before I can join the cognitive training.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants engage in Cogmed+ program, including digital cognitive rehabilitation and memory strategy training, with weekly videoconference coaching

5-8 weeks

Weekly videoconference calls

Follow-up

Participants are monitored for adherence and effectiveness of the Cogmed+ program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cogmed+

Trial Overview The trial tests a digital program called Cogmed combined with social support and memory strategies to see if it helps improve working memory skills in youth with sickle cell disease. It's not randomized; all participants will receive this combination treatment.

How Is the Trial Designed?

Group I: Cogmed+ Experimental Treatment 1 Intervention

Home-based digital cognitive rehabilitation and memory strategy training targeting working memory functioning.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Published Research Related to This Trial

Computerized cognitive rehabilitation therapy (CCRT) was found to be feasible and well-accepted among 81 Ugandan adults aged 50 and older, with 92.8% completing the program, and it showed significant improvements in learning and delayed recall tests compared to standard care.

CCRT demonstrated clinically important benefits for HIV-positive participants in areas like immediate recall and working memory, while also significantly reducing frailty-related phenotype in HIV-negative adults, indicating its potential as an effective intervention for cognitive decline in older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Rehabilitation Training for Ugandan Seniors Living with HIV: A Validation Study. Ezeamama, AE., Sikorskii, A., Sankar, PR., et al.[2021]

The COGNI-TRAcK app, designed for at-home cognitive rehabilitation, was well-received by 16 patients with multiple sclerosis, showing an 84% adherence rate and high levels of understanding and independence in using the app.

Patients reported positive experiences with the app, finding the exercises interesting and useful, which suggests that COGNI-TRAcK could be an effective tool for improving cognitive function in individuals with neurological impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New App for At-Home Cognitive Training: Description and Pilot Testing on Patients with Multiple Sclerosis. Tacchino, A., Pedullà, L., Bonzano, L., et al.[2022]

A new cognitive rehabilitation tool, CoRe, was developed to automate and personalize rehabilitation exercises for patients with cognitive impairments, tested on 38 healthy volunteers and 9 patients, showing favorable ratings and suggestions for improvement.

The tool aims to enhance patient compliance, especially among elderly individuals, by providing a variety of exercises and plans to evolve into a telerehabilitation system for home therapy, ensuring continuity of care and reducing costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based cognitive rehabilitation: the CoRe system. Alloni, A., Sinforiani, E., Zucchella, C., et al.[2018]

In a study involving 21 children with sickle cell disease (SCD) aged 7 to 16, 60% showed working memory (WM) deficits and participated in a home-based training program (Cogmed), with 50% completing the intervention.

Children who completed the Cogmed training demonstrated significant improvements in verbal working memory and visuospatial memory, suggesting that such interventions could help address cognitive challenges associated with SCD, although adherence to the program was lower than anticipated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Home-Based Computerized Working Memory Training With Children and Adolescents With Sickle Cell Disease. Hardy, SJ., Hardy, KK., Schatz, JC., et al.[2018]

A study involving 47 children with sickle cell disease showed that home-based digital working memory training (Cogmed) significantly improved visual working memory compared to a waitlist control group, indicating its potential efficacy for cognitive enhancement in this population.

Participants who completed at least 10 training sessions also demonstrated improvements in verbal short-term memory and math fluency, suggesting that sufficient engagement with the training is crucial for achieving cognitive benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of Working Memory Training in Pediatric Sickle Cell Disease. Hardy, SJ., Bills, SE., Meier, ER., et al.[2021]

The GRADIOR cognitive rehabilitation program has been developed over 20 years to effectively support cognitive evaluation and rehabilitation for individuals with mild cognitive impairment and mild dementia.

The latest version of GRADIOR features a dynamic and flexible structure that includes various management tools and exercises tailored to different difficulty levels, enhancing usability and effectiveness for both users and therapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based cognitive rehabilitation program GRADIOR for mild dementia and mild cognitive impairment: new features. Franco-Martín, MA., Diaz-Baquero, AA., Bueno-Aguado, Y., et al.[2023]

A pilot study involving 23 pediatric cancer survivors aged 7-19 demonstrated that a home-based computerized cognitive rehabilitation program can be effectively implemented, with an 83% compliance rate.

Participants showed significant improvements in processing speed, cognitive flexibility, and memory skills, along with increased activation in the pre-frontal cortex, indicating the program's potential efficacy in enhancing cognitive function in children recovering from cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of an online cognitive rehabilitation program for executive function skills in children with cancer-related brain injury. Kesler, SR., Lacayo, NJ., Jo, B.[2022]

In a study of 241 older adults in rehabilitation, all participants showed significant functional improvement in daily living activities, regardless of their cognitive status, indicating that rehabilitation can be beneficial for everyone.

However, those with lower cognitive scores experienced longer hospital stays and had higher rates of institutionalization and mortality, highlighting the need for tailored care in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does cognitive impairment affect rehabilitation outcome? Poynter, L., Kwan, J., Sayer, AA., et al.[2021]

In a study of 2436 individuals with sickle cell disease, self-reported cognitive difficulties, particularly in executive functioning and comprehension, were linked to poorer performance in daily living activities and lower medication adherence.

Cognitive dysfunction is common among adolescents and adults with sickle cell disease, and monitoring these cognitive symptoms can help healthcare providers better understand and address the functional challenges faced by these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported neurocognitive symptoms influence instrumental activities of daily living in sickle cell disease. Longoria, JN., Pugh, NL., Gordeuk, V., et al.[2022]

The Sickle Cell Disease Program for Learning and Neuropsychological Evaluation (SCD-PLANE) significantly improved access to neuropsychological testing for youth with sickle cell disease, identifying previously unmet cognitive and behavioral needs.

Results showed that despite normal intelligence, patients exhibited increased risks for issues with executive function, processing speed, and emotional symptoms, highlighting the importance of integrated neuropsychological support in routine care for this high-risk population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition planning for youth with sickle cell disease: embedding neuropsychological assessment into comprehensive care. Wills, KE., Nelson, SC., Hennessy, J., et al.[2010]

Cognitive and psychological difficulties, such as issues with executive function and increased anxiety or depression, are significant complications for pediatric patients with sickle cell disease (SCD) and should be considered as important endpoints in clinical trials.

The review identifies specific, reliable cognitive tests and patient-reported outcomes (like the NIH Toolbox Cognition Module and PROMIS scales) that can effectively measure the impact of SCD on patients' daily lives, emphasizing the need for patient-centered approaches in treatment evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations for Selecting Cognitive Endpoints and Psychological Patient-Reported Outcomes for Clinical Trials in Pediatric Patients With Sickle Cell Disease. Hood, AM., Crosby, LE., Stotesbury, H., et al.[2023]

In a study involving 300 children (150 severe malaria survivors and 150 non-malaria children), a limited version of computerized cognitive rehabilitation training (CCRT) significantly improved attention and memory outcomes in malaria survivors compared to passive controls, suggesting that focused practice may be more effective than more complex training.

Non-malaria children showed fewer cognitive benefits from CCRT, but those receiving the full CCRT had lasting improvements in planning and reasoning skills, indicating that the intensity and structure of cognitive training can influence long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological benefits of computerized cognitive rehabilitation training in Ugandan children surviving severe malaria: A randomized controlled trial. Boivin, MJ., Nakasujja, N., Sikorskii, A., et al.[2023]

The study involved 68 survivors of pediatric brain tumors and acute lymphoblastic leukemia, who were either given the Cogmed cognitive intervention or placed on a waitlist, showing that adherence to the program was consistent across different coaches.

While some aspects of participant satisfaction and cognitive outcomes were similar, the influence of different coaching styles on these results suggests that further research is needed to standardize coaching in computerized interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disseminability of computerized cognitive training: Performance across coaches. Fournier-Goodnight, AS., Ashford, JM., Clark, KN., et al.[2020]

A comprehensive cognitive rehabilitation program was developed based on a review of 33 studies, focusing on enhancing attention, memory, and problem-solving skills in brain-injured patients.

The program includes practical tasks that can be easily implemented by family members or nurses, aiming to help patients improve their cognitive abilities and adapt better to daily life challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of an integrative cognitive rehabilitation program for brain injured patients in the post-acute stage]. Oh, HS., Kim, YR., Seo, WS., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06770010

Advancing Feasibility and Acceptability of Digital Cognitive ... Outcomes will be assessed by examining the number of Cogmed sessions completed and rates of attendance to Cogmed Kickoff events and memory strategy training ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02857023

Feasibility and Efficacy of a Home-based, Computerized ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8164118/

Protocol for the Cognitive Behavioral Therapy and Real-time ... Association between participants' characteristics, patient-reported outcomes, and clinical outcomes in youth with sickle cell disease.

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1037/cpp0000313

Computerized Cognitive Training in Pediatric Sickle Cell ... The current study assessed the feasibility of a computerized cognitive intervention, Cogmed, in a sample of youth with SCD (ages 8–16 years).

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pbc.26019

Feasibility of Home‐Based Computerized Working Memory ... We also sought to collect preliminary efficacy data to aid in estimating effect sizes of Cogmed in a small sample of youth with SCD and, based ...

6. withpower.com withpower.com/trial/digital-cognitive-rehabilitation-for-sickle-cell-disease-27161

Digital Cognitive Rehabilitation for Sickle Cell Disease The research does not provide specific safety data for digital cognitive rehabilitation like Cogmed+ in humans, but it has been evaluated for feasibility ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01793740

Cognitive Rehabilitation in Sickle Cell Disease Thus, the goal of the present proposal is to address feasibility and compliance of a novel computerized cognitive training program, Cogmed.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11466366/

The Association Between Sickle Cell Anemia and Cognitive ... The most frequent neurological side effects linked to SCA include neurocognitive dysfunction, asymptomatic cerebral infarction, and ischemic stroke.

9. journals.lww.com journals.lww.com/pain/fulltext/2024/01000/a_cognitive_behavioral_digital_health_intervention.15.aspx

A cognitive–behavioral digital health intervention for... : PAIN A cognitive–behavioral digital health intervention for sickle cell disease pain in adolescents: a randomized, controlled, multicenter trial.