Recruiting

BCI-FES

Sponsor:

University of Alberta

Code:

NCT07269353

Conditions

Hemiparetic Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Brain Computer Interface - Functional Electrical Stimulations

Study Details

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

Study ID

NCT07269353

Start date

Feb 5, 2026

Status verified date

Feb, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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
2. Age 12-17 years,
3. Informed Consent/assent,
4. Normal corrected vision and hearing
5. Ability to maintain supported sitting for 30 min or more

Exclusion Criteria:

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

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Brain Computer Interface - Functional Electrical Stimulations

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.

Primary outcome measure

  • Melbourne Assessment 2 [ Time Frame: Baseline and immediately after the intervention ]
  • Safety and Tolerability Measure [ Time Frame: Baseline and immediately after the intervention ]

Central Contacts and Locations

Central contacts

Ephrem Zewdie, MD, PhD

(780) 492-2463etakele@ualberta.ca

Locations

Glenrose Rehabilitation Hospital

Recruiting

Edmonton, Alberta, Canada, T5G 0B7

Contacts

Monica Gorassini, PhD

(780) 492-2463mag4@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

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

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 Alberta on 2026-02-09.