Understanding Episodic Memory in Epilepsy

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Cognitive limits, Psychological limits, Pain, 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 how the brain manages learning, memory, and decision-making. Researchers seek to understand these processes better to eventually design treatments for learning and memory disorders. The trial uses specialized equipment, such as the Adtech Behnke-Fried micro-electrodes and the Blackrock Cerestim stimulator, to monitor brain activity during simple tasks. People with hard-to-control epilepsy who are already undergoing brain monitoring might be suitable candidates, especially if they can press buttons on a laptop to answer questions. As an unphased trial, participants can contribute to groundbreaking research that may lead to future treatments.

Will I have to stop taking my current medications?

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 study?

Previous studies have shown that Adtech Behnke-Fried micro-electrodes carry a very low risk of serious complications. For instance, one study found that only 0.4% of electrodes caused serious issues, with no infections or deaths reported, indicating general safety for brain monitoring.

Human studies have thoroughly tested the Blackrock Cerestim stimulator. It provides safe electrical stimulation, adhering to guidelines that maintain safe levels.

Researchers often use the Cedrus RB-844 response pad to record responses during tests. It poses no direct risks to users, as it serves as a data collection tool rather than a treatment device.

The Neurolynx electrophysiology system records brain activity and is a standard, safe tool for data gathering in research.

Overall, various studies have tested each of these tools for safety, and they are regularly used in research. This ensures they are well-tolerated and safe for participants in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring new ways to understand how epilepsy affects memory. Unlike traditional treatments that mainly focus on controlling seizures with medication, this study uses advanced technology like micro-electrodes and brain stimulators to record and analyze brain activity in real time. By diving deep into how neuronal signals relate to memory, researchers hope to uncover insights that could lead to more targeted therapies in the future. This approach is unique because it aims not just to treat symptoms but to understand the underlying brain processes, potentially paving the way for breakthroughs in managing memory issues in epilepsy patients.

What evidence suggests that these devices are effective for understanding episodic memory in epilepsy?

Research has shown that Adtech Behnke-Fried micro-electrodes, used in this trial, can test memory processes in people with epilepsy. These tiny devices measure brain activity with high accuracy, crucial for understanding memory function. Studies also indicate that the Blackrock Cerestim stimulator, another tool in this trial, can enhance memory by delivering small electrical pulses to specific brain regions. This stimulation has been shown to boost memory performance. The Cedrus RB-844 response pad records answers during memory tasks, aiding in the precise collection of data on memory function. Finally, the Neurolynx electrophysiology system monitors brain activity to study communication between brain areas during memory tasks, helping researchers learn more about memory operations in the brain. ^{3 6 7 8 9}

Who Is on the Research Team?

Adam Mamelak, MD

Principal Investigator

Cedars-Sinai Medical Center

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 already undergoing invasive monitoring. Participants should have an IQ over 70 and be able to understand and perform tasks on a computer by pressing buttons. Those unable to complete the tasks due to cognitive, psychological limits, or pain cannot join.

Inclusion Criteria

I am 13 years old or older.

You have an IQ score higher than 70.

I have severe epilepsy and am undergoing special monitoring.

Exclusion Criteria

I am unable to perform certain tasks due to cognitive, psychological issues, 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 memory strength and decision-making processes

3-5 years

Follow-up

Participants are monitored for safety and effectiveness after the main experimental procedures

6 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

The study aims to understand how humans learn, recall information, and make decisions using various devices: Cedrus response pad for inputs; Adtech micro-electrodes, Neurolynx system for brain activity recording; Blackrock stimulator possibly for stimulating specific brain areas during tests.

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+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

University of California, Santa Barbara

Collaborator

Trials

33

Recruited

3,100+

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+

Published Research Related to This Trial

The NeuroPace® RNS® System is a safe and effective neuromodulation device for patients with epilepsy who do not respond to traditional antiseizure medications, providing a nondestructive alternative to surgical resection.

Clinical trials have shown that the RNS System can detect and respond to epileptiform activity by delivering targeted electrical stimulation, which may lead to improved seizure control and could be adapted for other neurological disorders using advanced machine learning techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The RNS System: brain-responsive neurostimulation for the treatment of epilepsy. Jarosiewicz, B., Morrell, M.[2021]

The Mayo Epilepsy Personal Assistant Device (EPAD) is designed to enhance seizure prediction and management by integrating with the Medtronic Summit RC+STM device for real-time monitoring of brain activity, which could improve the effectiveness of neuromodulation therapy.

The EPAD system is currently undergoing a first-in-human trial involving ten patients with difficult-to-treat epilepsy, following extensive testing on canines, indicating a strong commitment to safety and regulatory compliance in its development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation. Pal Attia, T., Crepeau, D., Kremen, V., et al.[2022]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S1053811922002440

Long-term deep intracerebral microelectrode recordings in ...

Recordings allow testing of cognitive processes such as working and episodic memory, with temporal precision through single-trial studies in ...

2.

med.upenn.edu

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

Brain Stimulation

The research objective was to measure whether memory was better for items that received stimulation than those that did not, and whether this ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7472902/

Microelectrode recordings in human epilepsy: a case for ...

The majority of microelectrode recording studies in human epilepsy have evaluated the neural basis of cognition, most of them via the use of Behnke–Fried ...

4.

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 ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1935861X25003298

Characterizing neuronal and population responses to ...

We collected data from 34 hippocampally implanted Behnke-Fried electrodes across seven epilepsy patients. This unique approach allowed us to ...

6.

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 ...

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 ...

There were no infections or deaths. Serious or hemorrhagic complications occurred in 2 patients (0.4% per-electrode risk). Complications did not ...

9.

adtechmedical.com

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

Instructions for Use Behnke Fried and Wire Bundle Macro- ...

AD-TECH® Behnke Fried Depth Electrodes (BF). •. AD-TECH® Wire Bundle ... AD-TECH® has not verified the safety and performance of the Behnke.