Cognitive Rehabilitation Program for Intellectual Disability

Overseen By Yoon Jae Cho, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Blindness, Deafness, Recent clinical trial, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a computerized cognitive rehabilitation program, D-kit/EF1, might assist children with borderline or mild intellectual disabilities. Participants will use the program on an iOS device for 30 minutes, five times a week, over 12 weeks. The study compares the effects of this digital program with a control group that watches educational videos. Children diagnosed with borderline or mild intellectual disabilities who can engage in tablet activities may be suitable candidates. As an unphased trial, this study provides a unique opportunity for children to potentially benefit from innovative cognitive rehabilitation techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the D-kit/EF1 program is safe for children with intellectual disabilities?

Studies have shown that computerized programs like D-kit/EF1, which assist with thinking skills, are generally safe and well-tolerated. Although specific safety data for D-kit/EF1 is unavailable, similar programs typically pose no significant risks. These programs often use engaging quizzes to enhance brain functions, such as memory and problem-solving, in children with mild intellectual disabilities. Since this trial is exploratory and not focused on a medical procedure or drug, the risks are lower compared to traditional treatments. However, parents or caregivers should supervise the child to ensure safe use of the program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional methods for intellectual disability that often focus on behavioral therapy and medication, the D-kit/EF1 program introduces a unique approach by leveraging cognitive rehabilitation through a mobile tablet. Researchers are excited about this treatment because it offers an accessible, tech-driven solution that can be easily incorporated into daily routines. The program involves interactive sessions guided by the participant's caregivers, which fosters a supportive learning environment and encourages consistent engagement. This innovative delivery method not only makes cognitive training more engaging but also empowers caregivers to actively participate in the therapeutic process.

What evidence suggests that the D-kit/EF1 program is effective for intellectual disability?

Research has shown that the D-kit/EF1 program, a computerized tool for cognitive rehabilitation, aims to improve thinking skills in children, such as memory, flexible thinking, and self-control. In this trial, participants in the D-kit/EF1 group will use the program to enhance these skills. Although direct proof of D-kit/EF1's effectiveness for children with intellectual disabilities is not yet available, previous studies suggest that improving these thinking skills can enhance mental abilities in children with mild intellectual challenges. The program's fun, game-like quizzes aim to make learning enjoyable and effective for young users. ^{1 2 3 5 6}

Who Is on the Research Team?

Young Shin Kim, MD PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for children aged 4-8 with borderline intellectual functioning or mild intellectual disability. They must be able to communicate and participate in tests and activities, and their legal guardians must consent. Children who can't see, hear well, or have been in another drug trial recently can't join.

Inclusion Criteria

My child can communicate and follow instructions for tests and treatments in the trial.

My child is between 4 and 8 years old.

Individuals for whom the legal guardian and primary caregiver have voluntarily decided to participate in this clinical trial after receiving sufficient explanation and have provided written consent to comply with the requirements of the clinical trial.

Exclusion Criteria

Patients with conditions (e.g., blindness, color blindness, hearing loss, or deafness) that make it difficult to perform the digital therapy of the medical device for the clinical trial, D-kit/EF1, and the key assessment item for the clinical trial, NIHTB-CB DCCS test.

If the subject has participated in another clinical trial or has been administered investigational drugs for clinical trial purposes within the 4 weeks prior to screening (except, cases where the subject has not received investigational drugs or has participated in non-interventional observational studies are eligible for enrollment).

If the parents or primary caregiver of the trial subjects, who will perform the key assessments on the trial subjects, are unable to read or write in English, thus are impossible to conduct the assessments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the D-kit/EF1 program or watch educational videos 5 times a week for 30 minutes each session

12 weeks

Follow-up

Participants are monitored for changes in executive function and cognitive improvement

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• D-kit/EF1

Trial Overview The study examines a computerized cognitive rehabilitation program (D-kit/EF1) used on an iOS device versus a sham group watching educational videos. Kids will use the program or watch videos five times a week for 30 minutes over 12 weeks.

How Is the Trial Designed?

Group I: D-kit/EF1 group Experimental Treatment 1 Intervention

The experimental group will use the D-kit/EF1 program on a mobile tablet device at least 5 times a week for 30 minutes each session, for a duration of 12 weeks. The program will be performed under the supervision of the participant's parents or primary caregivers, following the provided program usage guide.

Group II: Sham group Placebo Group 1 Intervention

The sham group will watch an educational animation video on a mobile tablet device at least 5 times a week for 30 minutes each session, for a duration of 12 weeks. The sham program was designed to provide a similar experience as the experimental group by replacing the content within the same app. The control group uses the same mobile tablet device and accesses the app with the provided control group account. When accessing the app with the control group account, instead of the Adaptive Learning Lesson reflecting the principles of D-kit, educational animations created for educational purposes are provided. The educational animations are original animations created by DOBAIN Inc..

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

DoBrain Inc.

Industry Sponsor

Trials

1

Recruited

80+

Korea Health Industry Development Institute

Collaborator

Trials

50

Recruited

91,900+

Published Research Related to This Trial

Patients with mild cognitive impairment (MCI) showed significant improvements in daily living activities, mood, and both verbal and nonverbal episodic memory after participating in a 4-week multi-component cognitive rehabilitation program.

In contrast, patients with mild dementia experienced only a non-significant increase in verbal memory, highlighting that the rehabilitation program may be more beneficial for those with MCI than for those with more advanced cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in patients with mild cognitive impairment. Kurz, A., Pohl, C., Ramsenthaler, M., 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 of 68 patients with moderate-to-severe traumatic brain injury (TBI), those undergoing high-intensity rehabilitation (4 hours/day) showed a faster recovery, achieving higher scores on the Functional Independence Measure (FIM) and Glasgow Outcome Scale (GOS) in the early months compared to those in a lower intensity program (2 hours/day).

While early intensive rehabilitation improved recovery speed, it did not significantly change the final functional outcomes, suggesting that while it helps patients regain independence sooner, it may not affect long-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial. Zhu, XL., Poon, WS., Chan, CC., et al.[2014]

Citations

1. withpower.com withpower.com/trial/phase-intellectual-disability-8-2023-57e09

Cognitive Rehabilitation Program for Intellectual Disability What data supports the effectiveness of the treatment D-kit/EF1 for intellectual disability? While there is no direct evidence for D-kit/EF1 in intellectual ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05933005

Intervention Utilizing a Computerized Cognitive ... D-kit/EF1, a computerized cognitive rehabilitation program, incorporates game-type quizzes to enhance executive function in children with Mild ...

3. clinicaltrial.be clinicaltrial.be/fr/details/272688?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Intervention Utilizing a Computerized Cognitive Rehabilit... D-kit/EF1, a computerized cognitive rehabilitation program, incorporates game-type quizzes to enhance executive function in children with Mild ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8638729/

COGNITIVE FUNCTION AND PERFORMANCE OF ... The aims of this study were to explore cognitive impairments in adults with spina bifida and to consider associations between impairments, educational outcome ...

5. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/167/365

cognitive function and performance of everyday activities in ... This study investigated the relationship between cognitive impairments, school achievements and performance of daily life activities of 35 adults with spina ...

6. ichgcp.net ichgcp.net/clinical-trials-registry/NCT05933005

D-kit/EF1 and Sham group program in Mild Intellectual Disability and ... This clinical trial is a randomized, double-blind, parallel-group, exploratory study to confirm the efficacy of a computerized cognitive rehabilitation program ...