Digital Cognitive Rehabilitation for Sickle Cell Disease

(ALL IN Trial)

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

Trial Summary

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 data supports the effectiveness of the treatment Cogmed+ for cognitive rehabilitation in sickle cell disease?

Research on Cogmed, a computerized cognitive training program, shows it can help improve attention, working memory, and processing speed in children with brain injuries and cancer-related cognitive issues. This suggests it might also be beneficial for cognitive challenges in sickle cell disease. ^{1 2 3 4 5}

Is digital cognitive rehabilitation, like Cogmed+, safe for humans?

The research does not provide specific safety data for digital cognitive rehabilitation like Cogmed+ in humans, but it has been evaluated for feasibility and efficacy in children with sickle cell disease. ^{6 7 8 9 10}

How is the treatment Cogmed+ different from other treatments for sickle cell disease?

Cogmed+ is a digital cognitive rehabilitation treatment that uses computer-based exercises to improve cognitive function, which is different from traditional treatments for sickle cell disease that focus on managing pain and preventing complications. This approach is unique because it targets cognitive impairments that can occur in sickle cell patients, offering a novel way to enhance their quality of life. ^{3 11 12 13 14}

What is the purpose of this trial?

This is a single site nonrandomized pilot clinical trial of the feasibility, acceptability, and efficacy of a combination treatment involving digital Cogmed working memory skills training, social support components, and memory strategy training to improve adherence to Cogmed in youth with sickle cell disease ages 7-16 years.

Research Team

Steven Hardy, PhD

Principal Investigator

Children's National Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. England 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. [2022]

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

Disseminability of computerized cognitive training: Performance across coaches. [2020]

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

Neuropsychological benefits of computerized cognitive rehabilitation training in Ugandan children surviving severe malaria: A randomized controlled trial. [2023]

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

Does cognitive impairment affect rehabilitation outcome? [2021]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

[Development of an integrative cognitive rehabilitation program for brain injured patients in the post-acute stage]. [2019]

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

Feasibility of Home-Based Computerized Working Memory Training With Children and Adolescents With Sickle Cell Disease. [2018]

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

Patient-reported neurocognitive symptoms influence instrumental activities of daily living in sickle cell disease. [2022]

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

A Randomized Controlled Trial of Working Memory Training in Pediatric Sickle Cell Disease. [2021]

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

Transition planning for youth with sickle cell disease: embedding neuropsychological assessment into comprehensive care. [2010]

10. Switzerland 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. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Computer-based cognitive rehabilitation program GRADIOR for mild dementia and mild cognitive impairment: new features. [2023]

12. Canada pubmed.ncbi.nlm.nih.gov

A New App for At-Home Cognitive Training: Description and Pilot Testing on Patients with Multiple Sclerosis. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Rehabilitation Training for Ugandan Seniors Living with HIV: A Validation Study. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Computer-based cognitive rehabilitation: the CoRe system. [2018]