18 Participants NeededMy employer runs this trial

Brain Computer Interface for Severe Disabilities in Children

(BCI@home Trial)

Recruiting at 1 trial location
CC
Overseen ByCentral Contact Person
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how brain-computer interfaces (BCI) can help children with severe physical disabilities achieve personal goals at home. The main focus is to determine if BCI technology can improve life participation and assess the feasibility of this home-based program. Families will receive a BCI kit, including a headset and software, and participate in 12 virtual sessions over 3-6 months with flexible scheduling. Children aged 5-18 with severe motor or communication impairments who can follow simple instructions may be suitable candidates. The trial aims to make daily life easier for these children by using technology to help them reach their goals. As an unphased trial, it offers families the opportunity to explore innovative technology that could significantly enhance their child's daily life.

What prior data suggests that this brain computer interface is safe for children with severe disabilities?

Research has shown that brain-computer interfaces (BCIs) are generally well-tolerated by children with severe disabilities. One study found that these systems work well for children and are easy for them to use, allowing them to operate the technology without major issues. However, as with any new technology, minor challenges may arise during setup and operation. Overall, the research supports the safety of BCIs for children and highlights their potential to enhance daily activities for kids with severe disabilities.12345

Why are researchers excited about this trial?

Researchers are excited about the Brain Computer Interface (BCI) for severe disabilities in children because it offers a groundbreaking way for kids to interact with their environments using just their thoughts. Unlike typical therapies that rely on physical exercises or speech therapy, BCI taps directly into brain signals, allowing children to set and achieve personalized goals through a user-friendly headset and software. This at-home system provides flexibility and independence, empowering families to integrate therapy into their daily lives with ongoing support. The potential for BCI to significantly enhance communication and engagement for children with severe disabilities sets it apart from conventional methods.

What evidence suggests that this BCI is effective for severe disabilities in children?

Research has shown that brain-computer interfaces (BCIs) can significantly aid children with severe disabilities. Studies have found that these systems greatly enhance how these children interact with various applications. BCIs enable children to control devices with their thoughts, helping them achieve personal goals and improve their quality of life. Past experiences demonstrated that BCIs are practical and can be learned quickly, especially when tailored to the child. This technology is becoming a valuable tool for children with complex physical and social needs. Although more research is needed, the potential benefits for improving participation in daily activities are promising. Participants in this trial will use BCI at home, with support provided to help them achieve their goals.34678

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 5 and 18 years old.
My home is suitable for the treatment based on discussions with my doctor and family.
I cannot walk and have very limited use of my hands.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Home Program Setup

Families complete an in-person visit to review available activities, set goals, and learn to use BCI independently. A BCI 'kit' is provided.

1 visit
1 visit (in-person)

Home Program

Families participate in 12 virtual sessions over 3-6 months with flexible scheduling and daily online support.

3-6 months
12 visits (virtual)

Follow-up

Participants are monitored for achievement of participation-based goals and quality of life improvements.

6 months

Open-label extension (optional)

Participants may continue using BCI beyond 12 sessions with ongoing support.

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • BCI

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: BCI at homeExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Citations

Establishing a Clinical Brain-Computer Interface Program for ...

Patient-centered clinical BCI programs are feasible for children with severe disabilities. Carefully selected participants can often learn quickly to perform ...

BCI@Home: Brain Computer Interface Solutions to Enable ...

The goal of this trial is to evaluate use of brain computer interfaces (BCI) at home for children with severe severe physical disabilities.

On the feasibility of simple brain-computer interface ...

BCI-enabled PM access appears feasible in disabled children based on evaluations of performance, tolerability, workload, and setup/calibration.

Summary of the Inaugural Pediatric BCI Canada Meeting - PMC

Advancing brain-computer interface applications for severely disabled children through a multidisciplinary national network.

Effectiveness of brain-computer interface interventions in ...

However, the effectiveness of BCI-based interventions in ASD rehabilitation remains inconsistent across studies. Therefore, this protocol outlines a systematic ...

Brain-Computer Interfaces for Children With Complex ... - PMC

This systematic review presents the state-of-the-art of pediatric BCIs focused on developing advanced technology to support children and youth with ...

Family Experiences in a Pediatric Clinical Brain–Computer ...

Access to qualitative data collection methods designed to meet cognitive and communication needs of children with severe neuromotor disabilities ...

A Brain–Computer Interface System for Severe Disability ...

This research introduces a comprehensive BCI framework created to help people with severe disabilities interact with computer APIs merely by ...