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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves monitoring brain cell activity and using small electrical pulses to understand how memories are formed and used. It targets patients with drug-resistant epilepsy because their treatment allows direct study of brain activity. By observing and stimulating brain cells, researchers aim to learn more about memory and decision-making.

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 data supports the effectiveness of this treatment for understanding episodic memory in epilepsy?

The research suggests that certain brain activities, like theta-band coherence and hippocampal gamma oscillations, are important for memory tasks. These findings indicate that monitoring and potentially modulating these brain activities with devices like the ones used in the trial could help improve memory function in epilepsy patients. ^{1 2 3 4 5}

Is the treatment for understanding episodic memory in epilepsy safe for humans?

The RNS System, which is similar to the devices mentioned, has been used safely in humans for treating epilepsy by monitoring brain activity and delivering electrical stimulation to prevent seizures. It has been tested in clinical trials over several years, showing it to be a safe option for patients who do not respond to other treatments. ^{2 3 6 7 8}

How does this treatment for epilepsy differ from other treatments?

This treatment is unique because it focuses on understanding and improving episodic memory in epilepsy patients by studying brain activity, particularly in the hippocampus, which is crucial for memory. Unlike standard epilepsy treatments that primarily aim to control seizures, this approach investigates the underlying memory processes and brain networks involved, potentially offering insights into cognitive improvements. ^{1 3 8 9 10}

Research Team

Adam Mamelak, MD

Principal Investigator

Cedars-Sinai Medical Center

Ueli Rutishauser, PhD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

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+

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+

Findings from Research

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]

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]

References

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

Theta band network supporting human episodic memory is not activated in the seizure onset zone. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Epilepsy Personal Assistant Device-A Mobile Platform for Brain State, Dense Behavioral and Physiology Tracking and Controlling Adaptive Stimulation. [2022]

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

Hippocampal gamma predicts associative memory performance as measured by acute and chronic intracranial EEG. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Electrocorticographic events from long-term ambulatory brain recordings can potentially supplement seizure diaries. [2021]

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

Ripples in the medial temporal lobe are relevant for human memory consolidation. [2022]

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

The RNS System: brain-responsive neurostimulation for the treatment of epilepsy. [2021]

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

Chronic ambulatory electrocorticography from human speech cortex. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Activity of human hippocampal formation and amygdala neurons during memory testing. [2019]

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

Field potentials in the human hippocampus during the encoding and recognition of visual stimuli. [2007]

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

Coding of episodic memory in the human hippocampus. [2018]