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Recruiting NCT07269353

NCT07269353 Using Neurotechology to Help Children With Physical Disability Due to Cerebral Palsy

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Clinical Trial Summary
NCT ID NCT07269353
Status Recruiting
Phase
Sponsor University of Alberta
Condition Hemiparetic Cerebral Palsy
Study Type INTERVENTIONAL
Enrollment 8 participants
Start Date 2026-02-05
Primary Completion 2027-10-01

Eligibility & Interventions

Sex All sexes
Min Age 12 Years
Max Age 17 Years
Study Type INTERVENTIONAL
Interventions
Brain Computer Interface - Functional Electrical Stimulations

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 8 participants in total. It began in 2026-02-05 with a primary completion date of 2027-10-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

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)

Contact & Investigator

Central Contact

Ephrem Zewdie, MD, PhD

✉ etakele@ualberta.ca

📞 (780) 492-2463

Frequently Asked Questions

Who can join the NCT07269353 clinical trial?

This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Hemiparetic Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07269353 currently recruiting?

Yes, NCT07269353 is actively recruiting participants. Contact the research team at etakele@ualberta.ca for enrollment information.

Where is the NCT07269353 trial being conducted?

This trial is being conducted at Edmonton, Canada.

Who is sponsoring the NCT07269353 clinical trial?

NCT07269353 is sponsored by University of Alberta. The trial plans to enroll 8 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology