60 Participants Needed

Brain Activity Study for Epilepsy

Recruiting at 1 trial location
MS
Overseen ByMatthias Stangl
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston University Charles River Campus
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the brain processes spatial information, particularly in social settings where tracking others' movements is crucial. It focuses on people with epilepsy who have electrodes implanted in their brains, enabling researchers to observe brain activity during navigation tasks, such as the Observation task and Self-navigation task. Participants should have undergone specific epilepsy treatments involving electrode placement. The goal is to uncover how the brain encodes the movement of others and imagined navigation, potentially aiding in the development of therapies for neurological disorders. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could lead to new therapies for these disorders.

Do I need to stop 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.

What prior data suggests that this study's methods are safe for participants?

Research has shown that the activities in the study, such as watching and moving around independently, are generally safe for people with epilepsy. Individuals with epilepsy often engage in similar activities to monitor and manage their condition. In epilepsy monitoring units (EMU), where participants are observed, the risk of complications is low, around 2%. Most issues are minor, such as falls or brief seizures, occurring in up to 10% of cases. These units are designed for safety, providing participants with necessary support. Overall, these activities are well-tolerated and have a strong safety record in similar settings.12345

Why are researchers excited about this trial?

Researchers are excited about the Brain Activity Study for Epilepsy because it focuses on understanding how spatial navigation and memory work in the brain using tasks that involve self-navigation and observation. Unlike traditional treatments for epilepsy, which often include medications like anti-seizure drugs, this study uses electrophysiological recordings from participants with implanted electrodes to gather data directly from the brain. This approach could provide new insights into brain activity patterns and potentially lead to innovative strategies for managing epilepsy beyond medication. By exploring these direct brain interactions, the study aims to uncover new pathways for treatment that could improve the quality of life for those with epilepsy.

What evidence suggests that this trial's tasks could be effective for understanding spatial encoding in epilepsy?

Research has shown that the human brain uses special cells, like place cells and grid cells, to understand our location and movement. These cells also track the movement of others around us through brain activity patterns called deep brain oscillations, which resemble rhythmic waves. In this trial, participants will perform behavioral tasks to test their spatial navigation and memory performance in both self-navigation and observation tasks. The current research aims to learn more about how these brain patterns function when observing others and to determine if they can assist with other tasks, such as tracking objects or imagining movement through space. This could eventually lead to new treatments for brain disorders that affect spatial awareness, such as Alzheimer's disease.

Who Is on the Research Team?

MS

Matthias Stangl

Principal Investigator

Boston University

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-70 with epilepsy who have had depth electrodes placed or a NeuroPace RNS System implanted for treatment. They must be able to see and hear well enough for neuropsychological tests. People with psychiatric disorders (except nicotine-dependence) or brain damage cannot participate.

Inclusion Criteria

I can see and hear well enough for brain function tests.
I have had surgery for epilepsy either with depth electrodes or a NeuroPace RNS System.

Exclusion Criteria

All DSM-V Axis I and II disorders other than nicotine-dependence
History of brain damage

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-3 weeks
1 visit (in-person)

Recruitment and Consent

Participants are recruited and consented for the study, including discussions with the principal investigator and signing of consent forms

1-3 weeks
1 visit (in-person or virtual)

Task Performance and Data Collection

Participants perform spatial navigation and observation tasks while electrophysiological and eye movement data are collected

Up to 14 days
Daily sessions (in-person)

Follow-up

Participants are monitored for any post-study effects and data analysis is conducted

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Observation task
  • Self-navigation task
Trial Overview The study investigates how the human brain tracks spatial information about others' movements. It involves observation tasks and self-navigation tasks, recording deep brain activity in participants with implanted electrodes during these activities.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Electrophysiological recordings in participants with intracranially implanted electrodesExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston University Charles River Campus

Lead Sponsor

Trials
125
Recruited
14,100+

University of California, Los Angeles

Lead Sponsor

Trials
1,594
Recruited
10,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Boston University

Collaborator

Trials
494
Recruited
9,998,000+

Boston Medical Center

Collaborator

Trials
410
Recruited
890,000+

Citations

Evaluation and recommendations for effective data ...People with epilepsy and caregivers ranked hourly radar charts highest for protecting against errors in interpreting forecasts, reducing anxiety ...
The value of self-reported variables in epilepsy monitoring ...Among app and forecast users, 40 % found the forecast accurate for monitoring seizure risk, and 60 % used it for scheduling and mental well-being, while 40 % ...
Automatic Computer-Based Detection of Epileptic SeizuresAutomatic seizure detection systems can be based on direct analysis of epileptiform discharges on scalp-EEG or intracranial EEG.
Epilepsy monitoring units can be safe places; a prospective ...At our EMU, the overall complication risk is 2%. · There is no need for restricted ambulation at an EMU for noninvasive recordings. · Intranasal midazolam is ...
SAFETY-IN-THE-EPILEPSY-MONITORING-UNIT-(EMU)The most frequently reported SRAE are falls/traumatic injuries (up to 10% of recordings), status epilepticus (up to 10% of recordings ), bone ...
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