Enhancing Pediatric Neurorehabilitation: Integration of Brain-Computer Interface (BCI) and Functional Electrical Stimulation (FES) Technologies to Improve Upper Extremity Function in Children With Cerebral Palsy

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Hemiparetic cerebral palsy is a condition in which one side of a child's body becomes weak due to brain injury occurring around birth, often caused by stroke. Weakness on the affected side reduces the ability to use the involved hand and arm, limiting everyday activities such as dressing, eating, and playing. Few effective treatments currently exist, especially for children with severe weakness. The study described here examines a new therapy that combines Brain-Computer Interface (BCI) technology with Functional Electrical Stimulation (FES). BCI technology uses brain signals to control external devices; in this therapy, brain signals activate muscles through electrical stimulation. When a child imagines wrist movement, the system detects the associated brain activity and delivers electrical stimulation to generate actual movement. Such paired activity supports neural rewiring and strengthens connections between the brain and muscles, leading to improved arm function. Previous research demonstrates strong benefits of BCI-FES for adults after stroke, but minimal testing has been conducted with children. The current study will evaluate whether BCI-FES improves arm and hand function in children aged 12 to 17 with hemiparetic cerebral palsy. Participants will complete 15 to 20 sessions over a two-month period while wearing a cap that records brain signals. During each session, the system provides muscle stimulation and visual feedback through animated hand movements. Outcome measures will include performance of daily tasks, hand dexterity, muscle activity, and the presence of any adverse effects. The overarching goal is to create a fun, engaging, and effective therapy that supports recovery of hand use and greater independence. Successful results could guide larger studies and inspire new technology-based treatments that enhance quality of life for children with cerebral palsy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• Clinically confirmed and functionally disabling moderate to severe hemiparetic CP (GMFCS levels I-IV and MACS levels II\&III) with personalized goals that include improvement of wrist extension of affected upper extremity

• Age 12-17 years,

• Informed Consent/assent,

• Normal corrected vision and hearing

• Ability to maintain supported sitting for 30 min or more

Locations
Other Locations
Canada
Glenrose Rehabilitation Hospital
RECRUITING
Edmonton
Contact Information
Primary
Ephrem Zewdie, MD, PhD
etakele@ualberta.ca
(780) 492-2463
Time Frame
Start Date: 2026-02-05
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 8
Treatments
Experimental: Participants
Participant receiving 20 sessions of BCI + FES using recoveriX All Sessions = 90 Minutes During the first visit, participants will receive a detailed explanation of the study and undergo an eligibility screening conducted by an occupational therapist. Before the intervention start, at mid-point and after the intervention, several hand function assessments will be performed, including the Melbourne Assessment, Box and Blocks Test, and the ReJoyce Automated Hand Function Test (RAHFT). Participants will also complete a Safety and Tolerability Survey and the Stanford Survey. Investigators will then fit an EEG headset to record brain signals used to control Functional Electrical Stimulation (FES).~The intervention session will be take 90 mins and will include 60min of BCI-FES using a system called recoveriX.
Related Therapeutic Areas
Sponsors
Collaborators: Alberta Health services
Leads: University of Alberta

This content was sourced from clinicaltrials.gov