Brain-Computer Interface for Epilepsy
Trial Summary
What is the purpose of this trial?
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 by producing brain changes in the networks that modulate attention. The investigators intend to work with epileptic participants who do not respond to pharmacological treatment, who will undergo neurosurgery. The questions the study sets out to answer are: 1. is there an improvement of symptoms in an experimental group receiving the treatment versus a sham group receiving a simulation of the treatment? 2. does the application of the therapy before surgery reduce the recovery times of post-surgery cognitive deficits described in the literature? Making use of the information recorded from brain electrodes implanted before a participant's epilepsy surgery, the investigators will create a BCI decoder that works with the available activity sources to establish the level of attention of each participant when performing tasks. Participants: * will perform an offline phase first, which will consist of one day of evaluation, in which they will be familiarized with an attentional task. * will perform a training phase later, which will consist of several days of evaluation, where they will learn to modulate their level of attention. This modulation will be facilitated by the BCI decoder, which will classify the level of attention directly from the brain and provide visual feedback that the participant will use as a guide. If the participant is part of the experimental group (or BCI group), the feedback will work as described and should be easy to follow, but if the participant is part of the Sham group, the feedback will not work according to the brain activity of the actual participant, but according to that of another person. Because of this, a mismatch will be created between the moments a brain experiences inattention, and participants believe they are experiencing inattention. This is a randomized, double-blind study, in which the experimenters will evaluate how the effect of the attentional therapy with BCI affects an BCI group and a Sham group.
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 data supports the effectiveness of the treatment Invasive Brain-Computer Interfaces for epilepsy?
Research shows that invasive brain-computer interfaces, which involve implanting electrodes in the brain, help accurately locate the areas causing seizures in epilepsy patients. This precise localization can make epilepsy surgery more effective and safer, as it allows doctors to target the problematic brain regions more accurately.12345
Is the Brain-Computer Interface for Epilepsy generally safe for humans?
Research on invasive brain-computer interfaces, often used in epilepsy treatment, suggests that these devices can be safely used in humans. Studies involving subdural and depth electrodes, which are similar to brain-computer interfaces, have shown that with careful monitoring and proper use, the procedures are generally safe and effective.12678
How is the Brain-Computer Interface treatment for epilepsy different from other treatments?
The Brain-Computer Interface (BCI) treatment for epilepsy is unique because it uses invasive devices to collect and interpret brain signals directly from the cortical surface, allowing for real-time processing and insights that are not possible with traditional methods. This approach can help in precisely localizing epileptic brain regions, which is crucial for effective epilepsy surgery, especially in patients who do not respond to medication.123910
Research Team
Diego Mac-Auliffe, Postdoc
Principal Investigator
The University of Texas at Austin
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Offline Phase
Participants perform an offline phase consisting of one day of evaluation to familiarize with an attentional task
Training Phase
Participants undergo several days of evaluation to learn to modulate their level of attention using the BCI decoder
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Invasive Brain-Computer Interfaces
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas at Austin
Lead Sponsor