BCI@Home: Brain Computer Interface Solutions to Enable Youth Living With Severe Disabilities

NCT07073378 | Recruiting

• 1 other identifier: REB25-0495
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this trial is to evaluate use of brain computer interfaces (BCI) at home for children with severe severe physical disabilities. The main questions it aims to answer are:

1. 1.Can a home BCI program enable children with disabilities to achieve personalized life participation goals?
2. 2.Can a home BCI program promote implementation reach?

Conditions

Cerebral Palsy; Pediatric Stroke; Genetic Condition; Acquired Brain Injury (Including Stroke)

Keywords

pediatric brain computer interface

Outcome Measures

Primary Outcomes (2)

• Canadian Occupational Performance Measure

  The primary effectiveness outcome is achievement of child and family-identified participation-based goals, as measured by the Canadian Occupational Performance Measure (COPM). Participants/families will set 3-5 goals, and then score the Importance, Performance, and Satisfaction with each goal on a 1-10 scale.

  Baseline and end of treatment at 6 months

• Implementation Reach

  The primary implementation outcome is the proportion of children recruited from equity-deserving groups. A baseline survey will capture comprehensive demographics.

  through study completion, an average of 2 years

Study Arms (1)

BCI at home

EXPERIMENTAL

Home BCI use. Families will first complete an in-person visit to review available activities, set their first goals, and learn to use BCI independently. A BCI "kit" will be given to each family, with a headset and the equipment and software required to pursue their identified goals. Following this, families will participate in 12 virtual sessions over 3-6 months. Scheduling will be flexible to accommodate complex family needs. Daily online support will be provided via a messaging application. Participants who choose to continue using BCI beyond 12 sessions will be provided kits and supported.

Device: Brain computer interface

Interventions

Brain computer interface DEVICE

Families will first complete an in-person visit to review available activities, set their first goals, and learn to use BCI independently. A BCI "kit" will be given to each family, with a headset and the equipment and software required to pursue their identified goals. Following this, families will participate in 12 virtual sessions over 3-6 months. Scheduling will be flexible to accommodate complex family needs. Daily online support will be provided via a messaging application. Participants who choose to continue using BCI beyond 12 sessions will be provided kits and supported.

BCI at home

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 5-18 years
• Severe motor impairment including inability to walk and minimal functional hand use, and/or;
• Severe communication impairment
• Ability to follow simple instructions and attend to simple tasks
• Home environment suitable for the program based on clinician and family discussion;
• Informed assent/consent

You may not qualify if:

• Epileptic encephalopathy
• Unstable epilepsy, or
• Brain imaging incompatible with BCI functionality

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (2)

Alberta Children's Hospital

Calgary, Alberta, Canada

RECRUITING

Glenrose Rehabilitation Hospital

Edmonton, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Genetic Diseases, Inborn; Brain Injuries

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Central Study Contacts

Central Contact Person

CONTACT

403-955-7816; alicia.hilderley@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Neurologist

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 18, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-07

Locations

CA (2)