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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a special program with fun games on tablets to help children with mild intellectual disabilities improve their thinking skills. The program aims to make their brains work better through consistent game play.

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 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 disability, studies show that intensive cognitive rehabilitation programs can improve functioning in people with brain injuries, suggesting that similar approaches might help those with intellectual disabilities. ^{1 2 3 4 5}

Is the Cognitive Rehabilitation Program for Intellectual Disability, also known as D-kit/EF1, safe for humans?

The available research highlights the importance of monitoring medication side effects in individuals with intellectual disability, as they are at higher risk for adverse effects due to complex healthcare needs and polypharmacy (use of multiple medications). While specific safety data for D-kit/EF1 is not provided, the general recommendation is to use medications cautiously, with regular monitoring to manage potential side effects. ^{6 7 8 9 10}

How is the D-kit/EF1 treatment for intellectual disability different from other treatments?

The D-kit/EF1 treatment is unique because it focuses on cognitive rehabilitation, which can be done in the patient's home or work environment, making it more accessible and personalized compared to traditional methods that often require clinical settings. ^{1 11 12 13 14}

Research Team

Young Shin Kim, MD PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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 is between 4 and 8 years old.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Community integration and satisfaction with functioning after intensive cognitive rehabilitation for traumatic brain injury. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Description of an interdisciplinary, holistic cognitive rehabilitation program for adults with mild to moderate cognitive impairment after acquired brain injury. [2023]

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

Does intensive rehabilitation improve the functional outcome of patients with traumatic brain injury (TBI)? A randomized controlled trial. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Programme evaluation of a geriatric rehabilitation day hospital. [2017]

5. England pubmed.ncbi.nlm.nih.gov

A home programme for patients with cognitive dysfunction: a pilot study. [2019]

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

Psychotropic medication use for adults and older adults with intellectual disability; selective review, recommendations and future directions. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The convergent and divergent validity of the Matson Evaluation of Drug Side-effects (MEDS) and the Dyskinesia Identification System: Condensed User Scale (DISCUS). [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Rating scales to measure adverse effects of medications in people with intellectual disability: a scoping review. [2022]

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

Pharmacogenomic Studies in Intellectual Disabilities and Autism Spectrum Disorder: A Systematic Review. [2022]

10. Argentina pubmed.ncbi.nlm.nih.gov

[Pharmacological interventions for intellectual disability and autism]. [2020]

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

Cognitive training in home environment. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in patients with mild cognitive impairment. [2022]

13. England pubmed.ncbi.nlm.nih.gov

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

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

Cognitive training in adults with intellectual disability: pilot study applying a cognitive tele-rehabilitation program. [2022]