Neural Computations for Decision-Making in Epilepsy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Cognitive limits, Psychological limits, Pain

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

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

Do I need to stop my current medications for this 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 data supports the effectiveness of the treatment Adtech Behnke-Fried micro-electrodes, Cedrus RB-844 response pad, Neurolynx electrophysiology system for decision-making in epilepsy?

Research shows that using microelectrode arrays can help predict epileptic seizures by analyzing brain signals, which may improve seizure management and treatment planning. High-density micro-electrocorticography electrode arrays have been effective in identifying microseizures, potentially aiding in more accurate localization of epileptogenic tissue for surgical interventions. ^{1 2 3 4 5}

Is the neural computation treatment for decision-making in epilepsy safe for humans?

Research shows that the neural interfaces used in epilepsy treatments, like the Adtech Behnke-Fried micro-electrodes, have been safely used in humans and animals. Studies indicate that these devices can be used for up to two weeks in humans with minimal tissue reaction, suggesting they are generally safe for short-term use. ^{2 6 7 8 9}

How does the treatment using Adtech Behnke-Fried micro-electrodes, Cedrus RB-844 response pad, and Neurolynx electrophysiology system differ from other epilepsy treatments?

This treatment is unique because it uses advanced technology to predict and detect seizures by recording and analyzing brain activity in real-time, allowing for timely interventions. Unlike traditional treatments that rely on continuous medication or electrical stimulation, this approach focuses on precise, data-driven responses to seizure activity. ^{1 5 10 11 12}

What is the purpose of this trial?

The purpose of this research is to better understand how the human brain accomplishes the cognitive task of making goal-directed decisions. These investigations are critical to better understand human cognition and to design treatments for disorders of decision making and performance monitoring.

Research Team

Adam Mamelak, MD

Principal Investigator

Cedars-Sinai Medical Center

Ueli Rutishauser, PhD

Principal Investigator

Cedars-Sinai Medical Center

John O'Doherty, PhD

Principal Investigator

California Institute of Technology

Eligibility Criteria

This trial is for individuals aged 13 or older with intractable epilepsy who are undergoing invasive monitoring. Participants must be able to understand and perform tasks using a computer response pad, and have an IQ over 70. Those unable to complete the tasks due to cognitive, psychological limits, or pain cannot join.

Inclusion Criteria

I am 13 years old or older.

I can understand and respond to simple tasks on a computer.

Full Scale Intelligence Quotient > 70

Exclusion Criteria

Determination by clinicians and investigators that a patient is unable to complete the behavioral tasks required for the protocol due to either cognitive limits, psychological limits, or pain

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Behavioral Testing

Participants undergo behavioral and neuronal recordings to assess decision-making processes

5 years

Follow-up

Participants are monitored for safety and effectiveness after the main testing phase

4 weeks

Treatment Details

Interventions

• Adtech Behnke-Fried micro-electrodes
• Cedrus RB-844 response pad
• Neurolynx electrophysiology system

Trial Overview The study tests how people with epilepsy make decisions by using a Cedrus RB-844 response pad, Adtech Behnke-Fried micro-electrodes, and Neurolynx electrophysiology system during goal-directed tasks.

Participant Groups

Group I: Behavioral Testing Experimental Treatment 1 Intervention

Behavioral and Neuronal Recordings

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

California Institute of Technology

Collaborator

Trials

17

Recruited

4,300+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

A new hybrid depth electrode (HDE) method allows for high-quality in vivo microelectrode recordings from individual neurons in patients with epilepsy, enhancing the ability to study brain activity during clinical procedures.

In a study involving six patients with medically refractory epilepsy, the HDE provided excellent recordings over 5 to 14 days, enabling detailed physiological investigations while patients remained comfortable and cooperative.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hybrid clinical-research depth electrode for acute and chronic in vivo microelectrode recording of human brain neurons. Technical note. Howard, MA., Volkov, IO., Granner, MA., et al.[2006]

References

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

Intracortical neural activity distal to seizure-onset-areas predicts human focal seizures. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Multiple microelectrode-recording system for human intracortical applications. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Intraoperative microseizure detection using a high-density micro-electrocorticography electrode array. [2023]

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

Evolving into epilepsy: Multiscale electrophysiological analysis and imaging in an animal model. [2013]

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

Towards real-time in-implant epileptic seizure prediction. [2020]

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

A hybrid clinical-research depth electrode for acute and chronic in vivo microelectrode recording of human brain neurons. Technical note. [2006]

7. Germany pubmed.ncbi.nlm.nih.gov

Long-term recording performance and biocompatibility of chronically implanted cylindrically-shaped, polymer-based neural interfaces. [2019]

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

Selective electrical interfaces with the nervous system. [2005]

9. England pubmed.ncbi.nlm.nih.gov

Three dimensional microelectrodes enable high signal and spatial resolution for neural seizure recordings in brain slices and freely behaving animals. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Early seizure detection for closed loop direct neurostimulation devices in epilepsy. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Online detection and sorting of extracellularly recorded action potentials in human medial temporal lobe recordings, in vivo. [2006]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Detection of epileptiform discharges in the EEG by a hybrid system comprising mimetic, self-organized artificial neural network, and fuzzy logic stages. [2019]