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Perinatal StrokePhase 1NCT07133347

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

A Phase 1 study of Perinatal Stroke and Hemiparetic Cerebral Palsy, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 . Read more about this study

Who is it for?
Ages 10 to 25 years
Conditions the study is for
Perinatal Stroke, Hemiparetic Cerebral Palsy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
25 Nov 2024to 15 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

  • Exclusion criteria include severe intellectual disability, unstable epilepsy, and orthopaedic surgery in the upper limb or botulinum toxin injection in the previous 6 months.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

Other trials in Canada

About this study

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?

Read the detailed description

Perinatal strokes are focal neurovascular brain injuries that affect 5 million people worldwide and can lead to lifelong physical disabilities. It is the leading cause of hemiparetic cerebral palsy (HCP) which is characterized as motor dysfunction on one side of the body. Even modest improvements in a child's hand function can positively impact participation and affect quality of life, which is why there is a push for therapeutic interventions during earlier developmental windows.

Functional electrical stimulation (FES) stimulates muscle contraction during activity performance through low-intensity electrical currents. When applied to the affected limb, it can reduce spasticity-related symptoms and improve range of motion (ROM) and strength. When a patient's attempted movement is paired with FES, it triggers the cortical activation of sensorimotor areas, the degree of which has been associated with functional improvement. In stroke rehabilitation guidelines for adults, upper extremity FES receives the highest evidence-based recommendation. However, it has not been adequately studied in children, largely due to challenges with engagement, since high repetition counts are required to achieve meaningful functional gains. Brain Computer Interfaces (BCI) work by converting intentional brain activity into commands that can be used to control external devices. BCIs have been recently under investigation for their role in stroke rehabilitation.Specifically, BCI paired with FES has been explored as a novel way to drive task-related neuroplasticity to improve motor impairments over time in adults with stroke. Evidence suggests BCI-FES may be effective in adult patients with stroke-induced hemiparesis. Despite the evidence of enhanced neuroplasticity, the use of FES and BCI in children remains limited. One study suggested BCI-FES is feasible and well-tolerated in children with perinatal stroke, but scored poorly on enjoyability, suggesting that uptake and engagement in the therapy require improved system design. Which is why, the investigators created a novel and engaging BCI-FES therapy designed for youth with the aim of increasing long-term efficacy.

Methods:

A multi-disciplinary team of therapists, engineers, researchers, clinicians, and patient partners helped design a BCI FES therapy that is integrated with social media. The resulting application was named FlickTok, a novel BCI/FES social media therapy system. FlickTok integrates three interacting components: 1) an EEG headset, 2) the FES system, and 3) an application to coordinate the two components with social media interactions.

Patient Partner Engagement The investigators engaged three youth patient partners to design and build a BCI-FES integrated with social media to ensure research focus was on patient identified priorities. Before development began, the investigatorsworked with the patient partners to ensure that the system aligned with target users They helped us pilot test the system to evaluate and improve technical performance and usability. Our patient partners were also actively involved in the study design, helping to develop and conduct the qualitative interviews and supported results interpretation.

EEG:

An EEG headset and sensors were used to read and record the user's brain activity. A gel-based g.tec97 headset used an EEG montage at FC5, FC1, FCz, FC2, FC6, C5 C3, C1, Cz, C2, C4, C6, CP5, CP1, CP2, CP6 with a reference electrode placed at FPZ and a ground electrode on the participant's earlobe.3 Data was recorded using the g.USBamp amplifier and EEG was sampled at 256 Hz.

FES:

The FES component was driven by a computer and stimulates the desired muscles for the execution of the target functional movement. Working with an occupational therapist (OT), the investigators chose three functional movements to target: wrist extension, thumb abduction, and finger extension. A set of disposable "2 × 2" carbon rubber electrodes were applied to the targeted motor nerves on the forearm individualized for each participant. Electrode placement differed between participants based on individual anatomy, function, and target movement chosen. If a target movement could not be generated with FES, the participant was excluded from the study.

Muscle stimulation was delivered using the Neurotrac Dual Channel Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stimulation (NMES) device with a remote switch. FES parameters differed between participants to maximize tolerability and was adapted if the participant became fatigued. To facilitate connecting the FES to the BCI output, the investigators built a custom designed micro controller-based interface that connected to a USB port, enabling direct communication from the computer to control the FES stimulator.

Application:

The FlickTok application was structured in two parts: a Python server that coordinated EEG signals built in-house using our open-source BCI software package, BCI-Essentials system. The custom BCI was used to classify the EEG signal as either 'Action' or 'Rest'. The second part consisted of an Electron-based user-facing application that integrated social media content and FES stimulation with the BCI. YouTube Shorts and Instagram Reels were used during both the training of the BCI and the session itself to increase participant engagement and motivation. To personalize the sessions, each participant chose a specific type of content they wanted to engage with.

Calibration of the BCI system consisted of twenty repetitions using a 2-second on, 2-second off protocol, adapted to identify periods of intentional "action" (on-condition) from "rest" (off- condition). This binary classification utilized a Riemannian Geometry based motor imagery classifier.100 After the training calibration, the application selected 2 second segments of the EEG data and triggered the FES if it was classified as attempted movement and did nothing if it was classified as rest (participants had the choice to trigger it if desired). There was a 5 second latency or 'rest' period after a swipe. The social media application was displayed on a monitor and coloured icons that represented the attempted movement were integrated to improve understanding of the system.

Being tested
Brain computer interface controlled functional electrical stimulation therapy integrated with social media
Keywords
pediatric brain computer interface, brain computer interface controlled electrical stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brain computer interface controlled functional electrical stimulation therapy integrated with social mediaDevice

    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)

Study groups in NCT07133347
Study groupRoleWhat they receive
Participant receiving three sessions of BCI + FES + Social Media interventionExperimentalAll 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
Receives: Device: Brain computer interface controlled functional electrical stimulation therapy integrated with social media

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)
  1. Qualitative Interview

    The qualitative, semi-structured interviews were conducted by a patient partner. She was trained by an experienced qualitative researcher and had previously conducted multiple practice interviews. An interview guide was used throughout. Interviews were audio-recorded and transcribed verbatim using Rev.com. Interview transcripts were analyzed using NVivo 14. Analysis was informed by an interpretivist paradigm, and that they were analysed using conventional content analysis. Two team members independently coded all transcripts, eventually leading to the generation of a codebook.

    Measured: Day 3

  2. Enjoyability survey

    A nominal ranked survey that asks the participant to rank the invention against 7 other common childhood activities. (going to the dentist, shot at the doctors, long car ride, birthday party, playing a game, watching TV, throwing up)

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

  3. Range of Motion Assessment

    A range of motion (ROM) assessment evaluates the extent to which a joint can move. ROM was assessed by measuring joint angles, using a goniometer.

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

  4. Box and Blocks Assessment

    The Box and Blocks Test (BBT) is a clinical assessment used to measure gross manual dexterity. It involves moving 1-inch blocks, one at a time, from one compartment of a partitioned box to the other, over a period of 60 seconds. The number of blocks transferred is used as a measure of hand dexterity.

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

  5. Repetitions with and without electrical stimulation

    All FlickTok sessions were recorded so that repetitions could be reviewed offline for accuracy and to code movement attempts. To ensure consistency across participants, all repetition counts were scaled to a per-hour rate. Repetitions per hour were calculated by counting the number of attempts with and without assistance from FES. Repetitions without FES included the full training duration, as training did not incorporate FES-assisted repetitions. All repetitions were the sum of repetitions with and without FES.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2025
  2. Study start25 Nov 2024
  3. Primary completion20 Apr 2025
  4. Study completion15 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07133347
Sponsor's protocol ID
REB24-0528
Status last verified
Aug 2025
First submitted
15 Jul 2025
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Not not gather required permissions from the participants.

Publications

  • Bourgeois A, Maiani M, Minhas A, Shaw P, Nikitovic D, Irvine B, Robu I, Brand N, Jadavji Z, Wilding G, Ambrogiano M, Schrag E, Hilderley A, Marquez DC, Carlson HL, Romanow N, Kirton A, Kinney-Lang E. Creating an engaging brain computer interface, electrical stimulation therapy for children with hemiparesis: a pilot study. J Neuroeng Rehabil. 2026 Apr 24;23(1):183. doi: 10.1186/s12984-026-01990-z.

    PubMed 42032610

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Perinatal Stroke and Hemiparetic Cerebral Palsy, run by University of Calgary at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Training accuracy and Cohen' Kappa (time frame: Taken on Day 1, Day 2 and Day 3 of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07133347, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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