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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the brain makes decisions, with the goal of designing treatments for decision-making disorders. Researchers will use special sensors and recording devices, such as the Adtech Behnke-Fried micro-electrodes and the Neurolynx electrophysiology system, to track brain activity during simple tasks. The trial seeks participants with treatment-resistant epilepsy who are undergoing invasive monitoring and can respond to questions by pressing buttons on devices like the Cedrus RB-844 response pad. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in understanding brain function and decision-making.

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 prior data suggests that these devices are safe for use in this trial?

Research shows that the treatments in this trial, such as the Adtech Behnke-Fried micro-electrodes, have a good safety record in humans. Studies have found these electrodes to be as safe as standard ones used for brain monitoring. They have been used in patients with difficult-to-treat epilepsy without major issues.

The Cedrus RB-844 response pad is also part of this study, though specific safety data is limited. However, its common use in research to record responses suggests it is likely safe for people.

The Neurolynx system records brain activity and is frequently used in epilepsy and neurological research, indicating it is considered safe and effective for these purposes.

Overall, the devices in the study have been used in similar situations before, suggesting they are well-tolerated in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial on neural computations for decision-making in epilepsy because it uses cutting-edge technology to explore the brain's decision-making process in individuals with epilepsy. Unlike traditional treatments that primarily focus on controlling seizures with medication, this approach uses advanced tools like Adtech Behnke-Fried micro-electrodes and the Neurolynx electrophysiology system to record brain activity with high precision. This could potentially reveal new insights into how brain signals relate to decision-making, offering a deeper understanding of the condition and opening the door to innovative treatment strategies.

What evidence suggests that these devices are effective for decision-making in epilepsy?

Research has shown that Adtech Behnke-Fried micro-electrodes effectively record brain activity in people with epilepsy. Patients with difficult-to-treat epilepsy have safely used them to monitor seizures. Studies indicate that these electrodes can capture complex brain signals, providing insights into brain function and decision-making. In this trial, participants will undergo behavioral testing using these electrodes to gather neuronal recordings.

The Cedrus RB-844 response pad records responses during thinking tasks. It is part of research to understand brain activity related to decision-making. While it doesn't directly treat epilepsy, it helps gather data to understand brain processes. Participants in this trial will use the response pad during behavioral testing to provide insights into decision-making processes.

The Neurolynx electrophysiology system is known for recording detailed brain activity. Studies have used it to track changes in brain signals during seizures, helping researchers learn more about epilepsy. In this trial, the Neurolynx system will be used alongside other tools to study brain function and decision-making in epilepsy, contributing to the development of new treatments. ^{1 3 6 7 8}

Who Is on the Research Team?

Adam Mamelak, MD

Principal Investigator

Cedars-Sinai Medical Center

John O'Doherty, PhD

Principal Investigator

California Institute of Technology

Ueli Rutishauser, PhD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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

Full Scale Intelligence Quotient > 70

I am 13 years old or older.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1053811922002440

Long-term deep intracerebral microelectrode recordings in ... During the last 10 years, we implanted 122 bundles of Behnke-Fried hybrid macro-microelectrodes, in 56 patients with pharmacoresistant focal ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4019382/

Methods for implantation of micro-wire bundles and ... The authors report methods developed for the implantation of micro-wire bundles into mesial temporal lobe structures and subsequent single neuron recording.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6291341/

Safety and Utility of Hybrid Depth Electrodes for Seizure ... Hybrid depth electrodes appear to be as safe and effective as standard depth electrodes for intracranial monitoring and provide unique opportunities to study ...

4. med.upenn.edu med.upenn.edu/ngg/assets/user-content/documents/jc-2021-2022/week1-paper1.pdf

Brain Stimulation The study participants were 22 patients (Table S1) with phar- macoresistant epilepsy who had been implanted with intracranial depth electrodes ...

5. researchgate.net researchgate.net/figure/Automatic-electrode-detection-results-from-48-datasets-containing-4695-total-electrode_fig3_356896915

Automatic electrode detection results from 48 datasets ... In this study, we recorded intracranial EEG data from a cohort of patients with medically refractory epilepsy as they completed a visual recognition memory task ...

6. adtechmedical.com adtechmedical.com/sites/default/files/inline-files/AT10036-1-B%2C%20Rev.%20E%20BF%20and%20WB%20Depth%20Electrodes%20%28EU%29_0.pdf

Instructions for Use Behnke Fried and Wire Bundle Macro- ... Instructions for Use Behnke Fried and Wire Bundle Macro-Micro Depth Electrodes. AT10036-1-B, Rev. E. © AD-TECH ® 2025. Page 1 of 63.

7. adtechmedical.com adtechmedical.com/epilepsy

Epilepsy Epilepsy/LTM* depth electrodes are used for monitoring/mapping the subsurface levels of the brain for the surgical treatment of epilepsy.

8. europepmc.org europepmc.org/article/pmc/6291341

Safety and Utility of Hybrid Depth Electrodes for Seizure ... Invasive electrode monitoring provides more precise localization of epileptogenic foci in patients with medically refractory epilepsy.