Exploration for Epilepsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand the relationship between certain brain activities and visual and physical exploration in people with epilepsy. Participants will either explore virtual environments using VR glasses or walk between rooms while researchers monitor brain signals. Suitable candidates include individuals with epilepsy who have specific brain implants and experience fewer than one debilitating seizure per week, as well as healthy individuals who can walk and wear research equipment without assistance. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research in understanding epilepsy and brain function.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the treatments under study in this trial, Ambulatory Exploration and Visual Exploration, are generally safe.
For Ambulatory Exploration, studies have found that using devices to monitor seizures is usually well-tolerated. One long-term study lasting nine years showed that these brain devices reduced seizures by an average of 75%, with no major safety issues reported.
Regarding Visual Exploration, safety appears promising as well. Past research on visually sensitive seizures found that treatments involving visual tasks are safe for patients. Studies on pattern-sensitive epilepsy, a type of epilepsy triggered by visual patterns, have shown that patients handle these visual treatments well over long periods.
Overall, both treatments have been studied extensively, and the results suggest they are safe for people with epilepsy. This should provide some reassurance for those considering joining a trial testing these methods.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores innovative techniques to understand and potentially improve epilepsy management. Unlike traditional epilepsy treatments, which often rely on medications or surgeries to control seizures, this trial uses immersive virtual reality environments to study eye movements and brain activity. By analyzing how patients interact with different visual and physical spaces, the trial aims to uncover new insights into brain function and how it relates to epilepsy. These findings could open the door to more personalized and effective strategies for managing the condition.
What evidence suggests that this trial's treatments could be effective for epilepsy?
In this trial, participants will engage in various exploration tasks to manage epilepsy. Research has shown that walking around and monitoring for seizures can aid in epilepsy management. Studies have found that a portable brain wave test, known as ambulatory EEG, detects seizures 72% of the time, outperforming older methods. This improved detection helps doctors better understand and treat epilepsy.
Research has also explored the relationship between visual experiences and epilepsy. Some studies suggest that specific visual tasks can help predict seizures. These studies use advanced methods like machine learning to analyze brain activity patterns and foresee possible seizures, providing a valuable tool for managing epilepsy. Participants in this trial will engage in either ambulatory exploration or visual exploration tasks to further investigate these findings.14678Who Is on the Research Team?
Anli Liu, MD, MA
Principal Investigator
NYU Langone Health
Are You a Good Fit for This Trial?
This trial is for individuals with epilepsy who are undergoing surgical treatment or have been implanted with RNS devices. It aims to understand the brain's activity during visual and physical exploration tasks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Visual Exploration in Surgical Patients
Participants will view between 10-15 panoramic environments using Meta Quest AR/VR glasses while their eye movements and head turns are tracked.
Ambulatory Exploration in RNS Patients and Healthy Controls
Participants will walk through and explore visually distinct rooms while wearing synchronized high-density EEG (hdEEG), eye-tracking glasses, and body position sensors.
Follow-up
Participants are monitored for safety and effectiveness after exploration activities
What Are the Treatments Tested in This Trial?
Interventions
- Ambulatory Exploration
- Visual Exploration
Trial Overview
The study examines hippocampal activity in two scenarios: when patients visually explore while monitored by iEEG during surgery, and when they move around (ambulatory exploration) with an RNS device.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Aim 2: Participants will walk between 4-6 rooms within an office floor. Each office will contain generic objects (office furniture, computers, lighting) and unique objects (artwork, photographs, books, and personal items). As control conditions, subjects will first be asked to walk around and between two empty rooms under different lighting conditions and speeds. Participants will also be asked to participate in all awake saccade control conditions (without a visual cognitive load).
Aim 2: Participants will walk between 4-6 rooms within an office floor. Each office will contain generic objects (office furniture, computers, lighting) and unique objects (artwork, photographs, books, and personal items). As control conditions, subjects will first be asked to walk around and between two empty rooms under different lighting conditions and speeds. Participants will also be asked to participate in all awake saccade control conditions (without a visual cognitive load).
Aim 1: Participants will be presented with between 10-15 unique immersive virtual environments (depending on patient tolerance) for patients to explore using VR glasses. Control tasks will be run to account for eye movements during non-navigation. For recording eye movements in darkness during REM sleep, as part of a control task, 4 electrodes will be placed above and below both eyes, a standard technique in polysomnographic studies.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NYU Langone Health
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Citations
Clinical utility of an ambulatory absence seizure detection ...
Novel absence seizure detection systems have emerged in recent years, showing consistent results in ambulatory monitoring.
A retrospective review of ambulatory video-EEG reports
This study evaluates the sensitivity and positive predictive value (PPV) of seizure diaries compared to ambulatory video-EEG reports.
Impact of ambulatory EEG in the management of patients ...
In patients with confirmed epilepsy and a first normal routine EEG, ambulatory EEG showed a diagnostic yield of 86%. •. The results of ...
Ambulatory seizure forecasting with a wrist-worn device ...
These results provide the first clear evidence that direct seizure forecasts are possible using wearable devices in the ambulatory setting for ...
Diagnostic Accuracy of Ambulatory EEG vs Routine EEG in ...
Results. Ambulatory EEG captured IED/seizures with a sensitivity of 72%, compared with 11% for the first rEEG and 22% for the second rEEG. The ...
Safety considerations in the epilepsy monitoring unit for ...
We reviewed EMU records from 116 PNES and compared them to 170 ES. Three falls (2.6%) occurred in PNES without injury compared to 6 falls (3.5%) in ES with 1 ...
Nine-year prospective efficacy and safety of brain- ...
At the completion of 9 years of treatment, the median percent seizure reduction was 75%, the responder rate was 73%, and more than one-third of patients had a ≥ ...
A Digital Intervention for Capturing the Real-Time Health ...
This innovative approach aims to tackle the apparently unpredictable nature of seizures by collecting real-time data on various seizure ...
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