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

ConditionsCerebral Palsy Pediatric Stroke Genetic Condition Acquired Brain Injury (Including Stroke)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age5-18

SponsorUniversity of Calgary

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Epileptic encephalopathy

Unstable epilepsy, or

Brain imaging incompatible with BCI functionality

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

18 Participants

are divided into 1 treatment group

Group A: BCI at homeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

through study completion, an average of 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Source ClinicalTrials.gov

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