Neurotechnology for Cerebral Palsy

Overseen By Ephrem Zewdie, MD, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Bilateral stroke, Severe hemiparesis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy for children with hemiparetic cerebral palsy, a condition causing weakness on one side of the body and affecting daily activities like dressing and playing. The therapy combines Brain-Computer Interface (BCI) technology with Functional Electrical Stimulation (FES) to improve arm and hand function. When a child imagines moving their wrist, the system detects brain activity and stimulates the muscles to create movement, promoting better brain-muscle connections. Children aged 12 to 17 with moderate to severe weakness in one arm, who struggle with tasks like extending their wrist, might be suitable for this trial. The goal is to develop a fun and effective therapy that helps children gain more independence.

As an unphased trial, this study provides a unique opportunity for children to access innovative therapy and contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this therapy is safe for children with cerebral palsy?

Research has shown that Brain-Computer Interface (BCI) technology combined with Functional Electrical Stimulation (FES) can improve arm and hand function in adults after a stroke. This method is now being tested for children with hemiparetic cerebral palsy. Earlier studies with children have successfully used BCI-FES, and it is generally well-tolerated.

In a small trial, BCI-FES proved safe and workable for children with hemiparetic cerebral palsy. Reports from this trial did not indicate any major side effects, suggesting that the treatment is well-tolerated. While most information comes from adult studies, early results from trials with children are promising. This therapy aims to be engaging and effective, helping children improve hand use and gain independence in daily activities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Brain-Computer Interface (BCI) with Functional Electrical Stimulation (FES) for cerebral palsy because it offers a novel approach to improving motor function. Unlike traditional therapies that focus on physical exercises and medications, this treatment directly engages the brain's neural pathways to enhance movement control. By using an EEG headset to capture brain signals and translate them into electrical stimulation, it helps retrain the brain and muscles to work together more effectively. This innovative method could lead to more significant improvements in hand function and overall mobility for people with cerebral palsy.

What evidence suggests that this BCI-FES therapy is effective for cerebral palsy?

Research has shown that Brain-Computer Interface (BCI) technology combined with Functional Electrical Stimulation (FES) may improve arm movement in individuals with brain injuries. Studies on adults who have experienced strokes found that BCI-FES enhances upper limb function by strengthening the connection between the brain and muscles. Although testing with children has been limited, early results suggest that BCI-FES can boost brain activity in children with cerebral palsy. In this trial, participants will receive BCI-FES therapy, which detects brain signals when a child imagines moving their wrist and then stimulates the muscles to make the movement occur. The goal is to help children regain hand use and perform everyday tasks more easily. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged 12 to 17 with hemiparetic cerebral palsy, which causes weakness on one side of the body due to a brain injury around birth. Participants should be able to complete multiple therapy sessions and have a goal of improving arm function.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit (in-person)

Training Sessions

Training calibrates the system by recording EEG signals during motor imagery of left or right wrist extension

3 weeks

15 to 20 sessions

Rehabilitation Sessions

Participants complete motor-imagery trials with visual and electrical feedback using the recoveriX system

3 weeks

15 to 20 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brain-Computer Interface (BCI) with Functional Electrical Stimulation (FES)

Trial Overview The study tests a new therapy combining Brain-Computer Interface (BCI) technology with Functional Electrical Stimulation (FES). It aims to improve hand and arm function by using brain signals to activate muscles during imagined movements.

How Is the Trial Designed?

Group I: Participants Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5080159/

Clinical usefulness of brain-computer interface-controlled ... The results of the present study suggest that BCI-controlled FES training may be helpful in improving brain activity in patients with cerebral palsy.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07269353

Using Neurotechology to Help Children With Physical ... Objectives Aim 1: Determine the efficacy of BCI-activated FES for children with hemiparetic cerebral palsy in improving functional outcomes.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0361923025001662

Advances in brain-computer interface controlled functional ... This paper reviews the application of BCI-FES in the recovery of upper limb function after stroke and explores its underlying mechanisms.

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1643536/full

Efficacy of brain–computer interface with functional ... Conclusion: The combined application of BCI-FES and tDCS appears promising for upper limb rehabilitation after stroke, with potential ...

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.120.030596?doi=10.1161/STROKEAHA.120.030596

Can Children With Perinatal Stroke Use a Simple Brain ... Children with perinatal stroke can achieve proficiency in basic tasks using simple BCI systems. Future directions include exploration of BCI- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10656959/

Boosting brain–computer interfaces with functional ... A technique that could potentially enrich the communication capacity of BCIs is functional electrical stimulation (FES) of paralyzed limbs and face.

7. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2023.1006242/full

BCI-activated electrical stimulation in children with ... We conducted a pilot clinical trial to assess the safety and feasibility of BCI-FES in children with hemiparetic CP.

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/1743-0003-8-49

Brain-Computer Interface Controlled Functional Electrical ... We describe the first successful integration of a noninvasive electroencephalogram (EEG)-based BCI with a noninvasive functional electrical stimulation (FES) ...