An interventional study of Brain Computer Interface - Functional Electrical Stimulations in Hemiparetic Cerebral Palsy, sponsored by University of Alberta. Recruiting at 1 site in Canada. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by University of Alberta · Not applicable, Interventional, and Treatment
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.
Purpose Hemiparetic cerebral palsy leads to severe unilateral motor weakness that impairs upper limb function and daily living in children. Effective, evidence-based therapies-particularly engaging, intensive interventions such as Brain-Computer Interface combined with Functional Electrical Stimulation (BCI-FES)-remain limited and underexplored in pediatric populations. The study aims to address this gap by adapting and validating a child-centered BCI-FES rehabilitation model for upper-extremity motor impairments, enabling effective and engaging therapy for children with hemiparetic cerebral palsy.
Objectives Aim 1: Determine the efficacy of BCI-activated FES for children with hemiparetic cerebral palsy in improving functional outcomes.
Aim 2: Develop, validate, and optimize a child-centered BCI-FES rehabilitation model that improves upper-extremity motor function and daily living activities in children with hemiparetic cerebral palsy, enabling scalable, effective neurotechnology-based therapies that enhance functional independence and quality of life within pediatric rehabilitation.
Method The setup combines EEG, FES, and real-time visual feedback to create a closed-loop training system. During each session, an EEG cap records motor-related brain activity while a participant imagines a specific movement (for example, wrist extension). When the system correctly identifies motor imagery, the system delivers FES to the corresponding muscles and displays the associated movement on a screen through an animated avatar.
The project uses the g.tec recoveriX system (g.tec, Schiedlberg, Austria), a commercially available BCI suite that integrates EEG recording and functional electrical stimulation.
BCI: EEG signals are recorded using a 16-channel, gel-based EEG headset. Recording electrodes are placed according to the international 10-10 system. The classification algorithm generates classification accuracy, defined as the percentage of correct predictions produced by the BCI when identifying intended motor-imagery commands.
FES: Electrical muscle stimulation is delivered bilaterally through two g.Estim electrical stimulators (g.tec, Graz, Austria), which generate rectangular biphasic constant-current pulses.
Visual Feedback: A monitor positioned directly in front of each participant displays two virtual hand avatars that provide real-time visual feedback mirroring intended movement. When the system successfully detects motor imagery, the avatar performs the corresponding movement on the screen.
Intervention The intervention consists of two components: Training Sessions and Rehabilitation Sessions.
Training Sessions: Training calibrates the system by recording EEG signals during motor imagery of left or right wrist extension. Participants are guided to visualize wrist extension for both hands. Each session includes three trials of approximately 15 minutes. Each trial contains 80 runs lasting 8 seconds.
Rehabilitation Sessions: During rehabilitation, the classifier generated during training drives visual and electrical feedback. Participants complete up to three trials per session, using audio cues to guide motor-imagery attempts. Visual feedback and electrical stimulation are provided only when motor imagery is accurately classified and matches the cue direction.
Participants attend 15 to 20 recoveriX sessions over three consecutive weeks. Each session lasts up to 90 minutes and includes randomized motor-imagery trials involving both limbs. Sessions are adjusted according to participant tolerance, with scheduled rest periods and optional additional breaks to maintain comfort and engagement.
1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.
This study's planned enrollment of 8 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Time frame: 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.
Time frame: Baseline and immediately after the intervention
The ReJoyce Automated Hand Function Test (RAHFT)
It is a quick, easy, and standardised assessment tool which assesses a participants's range of motion, hand control, speed, and ¬finger dexterity through a variety of ADLs.
Time frame: Baseline and immediately after the intervention
Box and Block Test (BBT)
The BBT is an easy-to-administer, valid and reliable assessment of gross manual dexterity
Time frame: Baseline and immediately after the intervention
Stanford Expectations Scale (SETS)
It will be administered at baseline to assess participants' and parents' pre-treatment expectations.
Time frame: Baseline and immediately after the intervention
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Alberta