Creating an Engaging BCI/FES Therapy for Children With Perinatal Stroke Using Social Media

NCT07133347 | Completed Phase 1

• 1 other identifier: REB24-0528
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to evaluate the feasibility of a brain-computer interface controlled functional electrical stimulation (BCI-FES) social media integrated system for children with hemiparetic cerebral palsy . The main questions it aims to answer is: (1) Is the social media BCI-FES system a feasible therapeutic intervention?

Conditions

Perinatal Stroke; Hemiparetic Cerebral Palsy

Keywords

pediatric brain computer interface; brain computer interface controlled electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Training accuracy and Cohen' Kappa

  Cohen's kappa (a quantification of agreement in attempt accuracy) was calculated by defining a true positive value (TP) as FES being triggered within 6 seconds of the participant attempting a movement and defining false positive (FP) as the FES firing without an attempted movement. A true negative (TN) was defined as 6 seconds of the FES not firing when the participant did not attempt movement. A false negative (FN) was defined if the participant attempted a movement and Flick Tok did not trigger the FES for 6 seconds, in this case, the video was manually swiped. Repetitions with excessive movement/talking were removed for this calculation. Values were extracted by reviewing videos of participants during the three sessions. Cohen's kappa (κ): κ=(2(TP× TN- FN× FP))/((TP+FP)×(FP+TN)+(FP+ FN) ×(FN+TN)) Offline accuracy was extracted using a Riemannian Geometry based motor imagery classifier.

  Taken on Day 1, Day 2 and Day 3 of the study

Secondary Outcomes (5)

• Qualitative Interview

  Day 3

• Enjoyability survey

  end of session on Day 1, Day 2, Day 3

• Range of Motion Assessment

  ROM was taken immediately before and immediately after the intervention (day 1, day 2, day 3)

• Box and Blocks Assessment

  The box and blocks assessment was completed immediately before and immediately after the intervention (day 1, day 2, day 3)

• Repetitions with and without electrical stimulation

  Repetition were recorded during the sessions (day 1, day 2, day 3)

Study Arms (1)

Participant receiving three sessions of BCI + FES + Social Media intervention

EXPERIMENTAL

All sessions= 90 minutes Visit 1: Explain the study, confirm eligibility with an occupational therapist, and select a target movement. Hand function assessments were completed (AHA, box blocks), BRIEF survey, and range of motion testing. The investigators fit an EEG headset to record brain signals to control FES and social media. End with Box and blocks and range of motion Visits 2: Took these measures before and after: box and blocks, fatigue survey, and range of motion testing. Use EEG headset to record brain signals to control FES and social media. Visit 3 : Took these measures before and after: box and blocks, fatigue survey, and range of motion testing. Use EEG headset to record brain signals to control FES and social media. Afterwards the investigators conducted a qualitative interview to assess experience and therapy

Device: Brain computer interface controlled functional electrical stimulation therapy integrated with social media

Interventions

Brain computer interface controlled functional electrical stimulation therapy integrated with social media DEVICE

The investigators created an app interface (FlickTok) to have brain computer interface (g.tech gel 16 channel EEG headset) controlled functional electrical stimulation (NeuroTrac Electrical Stimulator) integrated with social media (Instagram reels or YouTube Shorts)

Participant receiving three sessions of BCI + FES + Social Media intervention

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The investigators recruited participants 10-25 years, with perinatal stroke and disabling hemiparetic cerebral palsy.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Study Officials

• Adam C Kirton, MD MSc FRCPC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Neurologist

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 21, 2025
• Study Start: November 25, 2024
• Primary Completion: April 20, 2025
• Study Completion: June 15, 2025
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)