Using Neurotechology to Help Children With Physical Disability Due to Cerebral Palsy

NCT07269353 | Recruiting

• 1 other identifier: Pro00156777
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemiparetic Cerebral Palsy

Keywords

Cerebral Palsy; BCI; FES; BCI-FES; Rehabilitation; Pediatric; Children

Outcome Measures

Primary Outcomes (2)

• Melbourne Assessment 2

  It is a standardized tool used to assess the quality of upper limb movement in children aged 2.5 to 15 years with neurological conditions such as cerebral palsy. It evaluates components like range of motion, accuracy, fluency, and dexterity through functional tasks.

  Baseline and immediately after the intervention

• Safety and Tolerability Measure

  Safety and tolerability assessment questionnaire will be completed following every session capturing and scaling predefined and any other potential side effects.

  Baseline and immediately after the intervention

Secondary Outcomes (3)

• The ReJoyce Automated Hand Function Test (RAHFT)

  Baseline and immediately after the intervention

• Box and Block Test (BBT)

  Baseline and immediately after the intervention

• Stanford Expectations Scale (SETS)

  Baseline and immediately after the intervention

Study Arms (1)

Participants

EXPERIMENTAL

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.

Device: Brain Computer Interface - Functional Electrical Stimulations

Interventions

Brain Computer Interface - Functional Electrical Stimulations DEVICE

This intervention combines EEG-based brain-computer interface (BCI) technology with functional electrical stimulation (FES), allowing participants to control muscle activation using their brain signals. Unlike traditional FES or passive rehabilitation methods, this approach actively engages the user's intent, potentially enhancing neuroplasticity and motor recovery.

Participants

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Bilateral perinatal stroke
• Motor strength of wrist extension zero
• Severe hemiparesis (MACS V)
• Severe developmental delay and/or other inability to comply with study protocol
• Severe wrist contractures limiting wrist extension
• Upper extremity orthopedic surgery or botulinum toxin in the preceding 6 months,
• Initial classification accuracy below level of significance (as determined by the BCI system)

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Ephrem Zewdie, MD, PhD

CONTACT

(780) 492-2463; etakele@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 8, 2025
• Study Start: February 5, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)