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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses advanced computer programs and real-time brain measurements to study how the brain works in epilepsy surgery patients. By recording and stimulating brain activity, researchers aim to understand how brain chemicals like dopamine, serotonin, and norepinephrine affect mood, attention, and behavior.

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 data supports the effectiveness of the treatment Behavioral testing under intracranial monitoring for epilepsy?

Research shows that combining behavioral testing with brain monitoring techniques, like EEG and microdialysis, can help understand how seizures affect brain activity and behavior. This approach has been useful in animal studies to track changes in brain chemicals and electrical activity during seizures, which can help in developing better treatments for epilepsy. ^{1 2 3 4 5}

Is the treatment for epilepsy safe for humans?

Research suggests that monitoring brain activity with EEG (a test that measures electrical activity in the brain) can help identify potential risks early in drug development, but animal studies don't always predict human safety. Some studies propose using EEG to detect early signs of seizures, which could help ensure safety in human trials. ^{6 7 8 9 10}

How does the treatment in the 'Brain Activity and Neurochemical Monitoring for Epilepsy' trial differ from other epilepsy treatments?

This treatment is unique because it uses a novel method to monitor brain activity and neurochemical changes simultaneously during seizures, providing real-time insights into the relationship between neurotransmitter levels and seizure activity. Unlike traditional methods, it offers high temporal resolution and less invasive monitoring, which can help better understand and manage epilepsy. ^{1 2 11 12 13}

Research Team

Robert Bina, MD

Principal Investigator

University of Arizona

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Novel method of monitoring electroencephalography at the site of microdialysis during chemically evoked seizures in a freely moving animal. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Microdialysis of Excitatory Amino Acids During EEG Recordings in Freely Moving Rats. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Behavioral seizure correlates in animal models of epilepsy: a road map for assay selection, data interpretation, and the search for causal mechanisms. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cerebral microdialysis combined with single-neuron and electroencephalographic recording in neurosurgical patients. Technical note. [2007]

5. England pubmed.ncbi.nlm.nih.gov

To quantify experience? Methodological issues in the behavioural/psychological treatment of complex partial seizures. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Novel test strategies for in vitro seizure liability assessment. [2023]

7. Denmark pubmed.ncbi.nlm.nih.gov

Adverse effects of anti-epileptics in trigeminal neuralgiform pain. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Behavioral toxicity associated with antiepileptic drugs: concepts and methods of assessment. [2019]

9. United States 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. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

A Framework Proposal to Follow-Up on Preclinical Convulsive Signals of a New Molecular Entity in First-in-Human Studies Using Electroencephalographic Monitoring. [2020]

11. England pubmed.ncbi.nlm.nih.gov

A microdialysis and enzymatic reactor sensing procedure for the simultaneous registration of online glutamate measurements at high temporal resolution during epileptiform activity. [2017]

12. United States pubmed.ncbi.nlm.nih.gov

An analytical flow injection system to measure glutamate in microdialysis samples based on an enzymatic reaction and electrochemical detection. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Use and Future Prospects of in Vivo Microdialysis for Epilepsy Studies. [2020]