Brain-Computer Interface for Epilepsy

Overseen By Liberty Hamilton, Professor

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Disqualifiers: Stroke, Brain injury, Severe disorders, others

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

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new brain-machine interface (BCI) therapy, specifically an invasive brain-computer interface, to determine its effectiveness in improving attention problems in individuals with medication-resistant epilepsy. Participants will have brain electrodes placed before their epilepsy surgery, and the BCI will aid them in learning to focus better through visual feedback. One group will receive real feedback based on their brain activity, while a comparison group will receive feedback not based on their own brain activity. The study seeks children and teens with epilepsy that does not respond to medication and who are planning to undergo brain surgery. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in BCI therapy for epilepsy.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, since it involves participants with drug-refractory epilepsy, it seems likely that you can continue your current epilepsy medications.

What prior data suggests that this brain-machine interface is safe for epilepsy patients?

Research has shown that surgically implanted brain-computer interfaces (BCIs) have been used safely in people. A review of several studies found these devices are generally well-tolerated, with most users not experiencing serious side effects. Some reported minor issues, such as headaches or mild discomfort at the implantation site, but these were uncommon.

One study examined the safety of a specific BCI placed in brain blood vessels. This study found the device could be used without causing major problems. It also demonstrated that people could control a computer with this system, indicating it functions as intended without causing harm.

These findings support the safety of BCIs for individuals with epilepsy who might not respond to medication. Although BCIs involve surgery, current research suggests they do not generally pose high risks. Always consult a healthcare provider to understand personal risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Brain-Computer Interfaces (BCIs) for epilepsy because they offer a groundbreaking approach compared to traditional treatments like medications and surgery. Unlike these standard options, BCIs can provide real-time brain activity monitoring and direct brain feedback, potentially allowing for more immediate and personalized seizure management. Specifically, one experimental method in this area involves giving users visual feedback controlled by their own BCI, which could empower patients by helping them understand and control their brain activity in a new way. Another unique method being explored uses feedback from another participant's BCI to test the effects of external brain activity inputs, offering insights into brain network dynamics.

What evidence suggests that this brain-computer interface is effective for improving attention in epilepsy patients?

Research has shown that brain-computer interfaces (BCIs) involving surgery offer potential benefits for people with medication-resistant epilepsy. In this trial, one group will receive visual feedback controlled by its own BCI, while another group will receive visual feedback from another randomly selected participant. Studies have found that BCIs can help control seizures through targeted brain stimulation. Early results suggest these devices might improve attention by teaching people to focus better using visual feedback of their brain activity. Researchers are also studying BCIs for their ability to aid recovery from thinking and memory problems after epilepsy surgery. Overall, while more research is needed, BCIs appear to be a promising option for improving attention and managing epilepsy symptoms. ^{1 2 3 5 6}

Who Is on the Research Team?

Diego Mac-Auliffe, Postdoc

Principal Investigator

The University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 8-21 with drug-resistant epilepsy, scheduled for neurosurgery, who can see normally or with correction, understand instructions in English or Spanish, and give informed consent. Excluded are those with stroke history, brain injuries, color blindness, certain implants or disorders (mental/neurological), severe physical impairments or illnesses (like cancer), substance abuse issues, pregnancy, and MRI safety conflicts.

Inclusion Criteria

iEEG implants on the GK network (ventro-lateral prefrontal cortex and executive network). Also desirable in areas related with attention and Action Phase processing

Normal to corrected vision

Ability to understand instructions to follow protocols

Exclusion Criteria

Severe intellectual and learning disabilities

Compromised consciousness

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Offline Phase

Participants perform an offline phase consisting of one day of evaluation to familiarize with an attentional task

1 day

1 visit (in-person)

Training Phase

Participants undergo several days of evaluation to learn to modulate their level of attention using the BCI decoder

1-2 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Invasive Brain-Computer Interfaces

Trial Overview The study tests if a customized BCI decoder improves attention in epileptic patients by comparing an experimental group using the BCI feedback to a sham group receiving mismatched feedback. It's randomized and double-blind; participants first learn an attention task without feedback then train to modulate attention levels using BCI visual feedback before surgery.

How Is the Trial Designed?

Group I: This arm will receive visual feedback controlled by its own BCI Experimental Treatment 1 Intervention

Group II: This arm will receive visual feedback from another randomly selected participant Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Published Research Related to This Trial

The study demonstrated that home monitoring of epilepsy patients using a subcutaneous EEG device is feasible and well tolerated, with no serious adverse events reported among the nine participants over a monitoring period of up to 3 months.

The device provided objective seizure counts that often differed significantly from patients' self-reported seizure diaries, revealing underreporting and important insights into seizure patterns and responses to antiepileptic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-long-term subcutaneous home monitoring of epilepsy-490 days of EEG from nine patients. Weisdorf, S., Duun-Henriksen, J., Kjeldsen, MJ., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6446441/

Brain–Computer Interface (BCI) Applications in Mapping of ... In this review, we will present the readers with potential targets for BCI in caring for patients with surgical epilepsy.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1878875024008672

The Recent Advances of Brain-Computer Interfaces in ... Recently, BCIs have also been proven effective in drug-resistant epilepsy. This is done through responsive neural stimulation (detection) as well as electrical ...

3. iopscience.iop.org iopscience.iop.org/article/10.1088/1741-2552/adb88e

a systematic review and individual patient meta-analysis Objective. Invasive brain-computer interfaces (iBCIs) have evolved significantly since the first neurotrophic electrode was implanted in a human subject three ...

4. mmrjournal.biomedcentral.com mmrjournal.biomedcentral.com/articles/10.1186/s40779-025-00598-z

Recent applications of EEG-based brain-computer-interface in ... This paper aims to offer a comprehensive review of recent electroencephalogram (EEG)-based BCI applications in the medical field across 8 critical areas.

5. trialx.com trialx.com/clinical-trials/listings/297254/invasive-brain-computer-interfaces-for-attention/

Invasive Brain-Computer Interfaces for Attention The goal of this interventional study is to compare if the use of a brain-machine interface (BCI) therapy can improve the symptoms of attentional deficit.

6. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2799839

Assessment of Safety of a Fully Implanted Endovascular ... This case series assesses the safety of an endovascular brain-computer interface and feasibility of using the system to control a computer ...