Recruiting

BCI

Sponsor:

University of Calgary

Code:

NCT07073378

Conditions

Cerebral Palsy

Pediatric Stroke

Genetic Condition

Acquired Brain Injury (Including Stroke)

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

Brain computer interface

Study Details

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

Conditions

Cerebral Palsy

Pediatric Stroke

Genetic Condition

Acquired Brain Injury (Including Stroke)

Study ID

NCT07073378

Start date

Nov 1, 2025

Status verified date

Jul, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BCI at home

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.

Interventions

Brain computer interface

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.

Primary outcome measure

  • Canadian Occupational Performance Measure [ Time Frame: Baseline and end of treatment at 6 months ]
  • Implementation Reach [ Time Frame: through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Central Contact Person

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

Locations

Alberta Children's Hospital

Recruiting

Calgary, Alberta, Canada

Contacts

Alicia Hilderley, PhD

403-955-2296alicia.hilderley@ucalgary.ca

Principal Investigator:

Adam Kirton, MD MSc

Glenrose Rehabilitation Hospital

Recruiting

Edmonton, Alberta, Canada

Contacts

Alicia Hilderley, PhD

403-955-2296alicia.hilderley@ucalgary.ca

Principal Investigator:

John Andersen, MD

More Information

Sponsor

University of Calgary

Last update posted

May 5, 2026

Last verified

Jul, 2025

Keywords

  • pediatric brain computer interface

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-05-05.