Brain Activity and Neurochemical Monitoring for Epilepsy

Overseen By Stephanie Marsh, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arizona

Disqualifiers: Cognitive dysfunction, Terminal illness, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore brain function by monitoring activity during epilepsy-related surgeries. Advanced technology records brain signals as participants engage in simple computer-based tasks. The study seeks to understand how these signals relate to conditions like anxiety and depression. People undergoing surgery for epilepsy who can perform these tasks may be suitable candidates. Participants should maintain stable medication doses for at least a month before surgery. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance understanding and treatment of neurological conditions.

Will I have to stop taking my current medications?

The trial requires that your medications be at stable doses for at least 1 month before surgery, so you may not need to stop taking them, but they should not be changed during this time.

What prior data suggests that this protocol is safe for epilepsy patients?

Research has shown that behavioral testing with intracranial monitoring is generally safe, though some risks exist. Studies have found that safety issues, such as multiple seizures occurring close together, occur in about 9% of people admitted for epilepsy monitoring. This indicates that while most people do not experience problems, some might.

One study demonstrated that a similar procedure, brain-responsive neurostimulation, significantly reduced seizures over nine years and maintained a good safety record. This suggests that while potential risks exist, they are often manageable, and the benefits can be significant.

Overall, these findings indicate that although some safety concerns may arise, the procedures involved in intracranial monitoring are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to monitor and understand epilepsy. Unlike traditional treatments that primarily focus on controlling seizures with medication, this approach uses intracranial electrodes to directly monitor brain activity and neurochemical changes during behavioral tasks. This method offers a unique opportunity to gain insights into the brain's real-time response to epilepsy, potentially leading to more targeted therapies in the future. By understanding these neurochemical processes, researchers hope to develop personalized treatment strategies that could improve outcomes for epilepsy patients.

What evidence suggests that behavioral testing under intracranial monitoring is effective for understanding epilepsy?

Research shows that special brain monitoring during tests can help locate the part of the brain causing seizures. In this trial, participants will undergo behavioral testing under intracranial monitoring to identify seizure origins. For some patients, this method greatly reduces seizures. Studies indicate that up to 50% of epilepsy surgeries require this type of direct brain recording to succeed. Advanced tools like machine learning enhance seizure tracking and aid in creating personalized treatment plans. While not every patient experiences improvement, many have fewer seizures, and some become seizure-free for extended periods. ^{1 2 6 7 8}

Who Is on the Research Team?

Robert Bina, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with intractable epilepsy or similar conditions requiring brain surgery, fluent in English, and able to consent. Excluded are those with significant cognitive dysfunction, terminal illness, MRI contraindications (like pacemakers), current or planned pregnancy during the study.

Inclusion Criteria

My medications have been the same for at least 1 month.

Fluency in English (necessary for uniform cognitive testing)

I am able to understand and agree to the study's requirements.

Exclusion Criteria

Terminal illness associated with <12 month survival

Current pregnancy or pregnancy planned during the course of the study

Cognitive function less than 2 standard deviations below normal on preoperative neuropsychological testing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Assessment

Standard clinical neuropsychological battery to assess aspects of cognitive function prior to surgery

1-2 weeks

Intracranial Monitoring and Behavioral Testing

Patients undergo behavioral tasks while being monitored by intracranial electrodes, including neurotransmitter concentration recording during cognitive tasks

1-2 weeks

During hospitalization

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Behavioral testing under intracranial monitoring

Trial Overview

The study tests how cognition and emotion behaviors are linked to brain activity using intracranial monitoring during behavioral tasks on a computer/iPad. It involves standard neuropsychological assessments pre-surgery and additional characterizations through questionnaires.

How Is the Trial Designed?

Group I: Behavioral testing under intracranial monitoring Experimental Treatment 1 Intervention

Patients will undergo behavioral tasks while being monitored by intercranial electrodes

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Arizona State University

Collaborator

Trials

311

Recruited

109,000+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

Published Research Related to This Trial

Monitoring brain activity using electroencephalography (EEG) during preclinical toxicology studies can help identify potential central nervous system (CNS) risks early in drug development, which is crucial for ensuring safety before human trials.

There is no single definitive marker for seizure risk in drug testing, but observing behavioral changes and plasma drug levels can help establish safety margins, indicating that a full EEG study may not always be necessary under current regulatory standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A predictive index of biomarkers for ictogenesis from tier I safety pharmacology testing that may warrant tier II EEG studies. Gauvin, DV., Zimmermann, ZJ., Yoder, J., et al.[2018]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12549316/

Seizure outcomes and complications associated with ...

For up to 50% of resective epilepsy surgeries, invasive monitoring with direct brain recordings is necessary to identify the EZ. Invasive ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9887634/

Intracranial electroencephalographic biomarker predicts ...

Although RNS is effective for many patients, approximately 10% of those who receive the device demonstrate no change or an increase in seizure frequency after 9 ...

3.

epilepsybehavior.com

epilepsybehavior.com/article/S1525-5050(25)00258-6/fulltext

Seizure outcomes after cortical stimulation-induced seizures

Among those with SIS, 20.0 % (1/5) became seizure free compared to 33.3 % (3/9) without SIS. A 50 % or greater seizure reduction occurred in ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1525505025000666

Unlocking new frontiers in epilepsy through AI

Machine learning and deep learning technologies improve seizure monitoring, automate EEG analysis, and facilitate tailored therapeutic strategies, addressing ...

5.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000010154

Nine-year prospective efficacy and safety of brain- ...

We found that 18.4% (47 of 256) experienced ≥1 year of seizure freedom, with 62% (29 of 47) seizure-free at the last follow-up and an average seizure-free ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1525505016301445

Safety in the epilepsy monitoring unit: A retrospective study ...

Safety adverse events occur in nearly 9% of EMU admissions. · Seizure clustering is the most common safety adverse event in the EMU. · Safety adverse events occur ...

7.

epilepsybehavior.com

epilepsybehavior.com/article/S1525-5050(23)00490-0/fulltext

Epilepsy monitoring unit practices and safety among NAEC ...

This study examines EMU staffing, safety practices, and reported outcomes. Method. We analyzed NAEC annual report data and results from a ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11144575/

Challenges and Prospects in Epilepsy Monitoring Units

The present article will concentrate on the logistic challenges of EMUs, discussing existing data and limitations and offering suggestions for future planning.