Brain Activity Monitoring for Epilepsy

Recruiting at 2 trial locations

Overseen By Sameer Sheth, MD, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Inability to understand, Epilepsy, others

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

Compensation: Varies

Number of Visits: Unknown

205 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how the brain creates and manages new plans and behaviors, focusing on areas involved in memory and decision-making. Researchers will monitor brain activity using computer tasks and questionnaires in an Epilepsy Monitoring Unit (EMU) and through the Neuropace RNS System, a device that can help control seizures. The trial is open to individuals with epilepsy who require intracranial electrodes for their treatment. Participants will help advance understanding of how the brain adapts and responds to different situations. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on brain function and epilepsy management.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What prior data suggests that this brain activity monitoring method is safe for epilepsy patients?

Research has shown that the Neuropace RNS System is generally safe for people with epilepsy. Studies have found that those using the RNS System have a much lower chance of experiencing SUDEP (sudden unexpected death in epilepsy) compared to individuals with difficult-to-treat epilepsy, indicating a positive safety profile.

Additionally, over time, patients have reported fewer seizures, suggesting that the device works well without causing major issues. Most importantly, the FDA has approved the device for treating epilepsy, confirming it has passed safety checks for this condition.

Overall, evidence suggests that the Neuropace RNS System is well-tolerated and safe for people with seizure conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for epilepsy focus on managing symptoms with medication. However, the Neuropace RNS System offers something different by using a responsive neurostimulator device that actively monitors brain activity and delivers electrical stimulation precisely when needed to prevent seizures. This real-time, personalized approach can lead to fewer side effects and improved seizure control. Researchers are excited about this technology because it represents a shift towards more tailored and proactive epilepsy management, potentially improving quality of life for patients.

What evidence suggests that this trial's treatments could be effective for epilepsy?

Studies have shown that the Neuropace RNS System, a treatment option in this trial, helps reduce seizures in people with drug-resistant focal epilepsy. On average, users experience a 62% reduction in seizures within the first six months. Over time, patients have seen a 75% reduction in seizures after nine years. Another study found that the system reduced seizures by 67% in many patients. These findings suggest that the RNS System is a promising option for those who haven't responded well to other treatments. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for male and female epilepsy patients aged between 10 and 64 who are having intracranial electrodes placed for their condition. Participants must be able to understand instructions and concentrate well enough to respond correctly during tasks.

Inclusion Criteria

Undergo placement of intracranial electrodes for clinical characterization of epilepsy

I am between 10 and 64 years old.

Exclusion Criteria

Inability to understand and follow instructions

I struggle to concentrate and often get things wrong because of it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Behavioral Task Performance

Participants perform novel computerized tasks to assess behavioral performance and accuracy

1-2 weeks

Daily sessions in the Epilepsy Monitoring Unit

Neurophysiological Activity Monitoring

Neural activity is measured using depth electrodes to understand neural representations during tasks

1-2 weeks

Continuous monitoring in the Epilepsy Monitoring Unit

Follow-up

Participants are monitored for safety and effectiveness after task performance

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EMU
• NEUROPACE RNS SYSTEM

Trial Overview The study is examining how the brain responds when creating new behaviors on-the-spot, focusing on specific brain areas: medial temporal lobe (MTL) and ventral prefrontal cortex (vPFC). It involves novel tasks, virtual reality environments, and direct brain stimulation.

How Is the Trial Designed?

Group I: Neuropace RNS Device Experimental Treatment 1 Intervention

Patients are implanted with RNS device to treat their seizure activity

Group II: Epilepsy Monitoring Unit Experimental Treatment 1 Intervention

Patient's behavioral and neural activity via computer tasks and questionnaires are monitored in the Epilepsy Monitoring Unit

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

The responsive neurostimulator (RNS) has been clinically used since 2013 to treat patients with medically refractory partial epilepsy, showing significant seizure reduction compared to sham stimulation in a randomized clinical trial.

Long-term use of the RNS has provided valuable data on epilepsy dynamics, including insights into seizure onset patterns and the potential for early detection of treatment benefits, although optimal patient selection and lead placement remain areas for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsive neurostimulation: Review of clinical trials and insights into focal epilepsy. Geller, EB.[2019]

In a study involving 16 patients with medically refractory focal epilepsy, robotic-assisted implantation of the responsive neurostimulation system (RNS) led to an impressive average seizure reduction of 82% at 6 months and 90% at 1 year, demonstrating its efficacy as a treatment.

The use of the ROSA robot for targeting ictal-onset zones resulted in a highly accurate lead placement, with only a 0.165-mm discrepancy between the expected and actual lead locations, indicating a precise method for improving seizure control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Robotic-Assisted Technique to Implant the Responsive Neurostimulation System. Tran, DK., Paff, M., Mnatsakanyan, L., et al.[2021]

In a study of 15 inpatients with frequent partial-onset seizures and cognitive or affective disorders, intravenous lacosamide significantly reduced seizure frequency by 75% in some patients, with 11 out of 15 experiencing no seizures after 2-3 days of treatment.

Lacosamide also positively impacted the emotional well-being and quality of life in 73.4% of patients, with only mild to moderate side effects reported in 2 patients, indicating it is a well-tolerated and effective option for drug-resistant seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The efficacy of intravenous lacosamide in psychiatric hospital]. Vakula, IN., Bojko, EO., Vorona, UA., et al.[2018]

Lacosamide is an effective antiepileptic drug that works by enhancing sodium channel inactivation and binding to CRMP2, helping to stabilize neuronal membranes and reduce seizures in patients with uncontrolled partial-onset seizures.

In clinical trials, lacosamide was generally well tolerated, with common side effects including dizziness and headache, and it has a favorable pharmacokinetic profile allowing for twice-daily dosing with low potential for drug interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lacosamide for the prevention of partial onset seizures in epileptic adults. Kelemen, A., Halász, P.[2021]

Lacosamide is effective as both monotherapy (in the USA) and adjunctive therapy for focal seizures in adults and adolescents, showing significant reductions in seizure rates compared to placebo in clinical trials.

Patients can safely switch from oral to intravenous lacosamide therapy at the same dosage, making it a flexible treatment option, especially when oral administration is not feasible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lacosamide: A Review in Focal Seizures in Patients with Epilepsy. Scott, LJ.[2018]

Lacosamide (Vimpat) is an antiepileptic drug that works through a dual mechanism: it enhances the slow inactivation of voltage-gated sodium channels and modulates the CRMP-2 protein, which is involved in neuroprotection.

Clinical studies have shown that lacosamide effectively reduces seizure frequency in patients with partial-onset seizures when used alongside other antiepileptic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Lacosamide. A new antiepileptic drug as adjunctive therapy in patients with partial-onset seizures]. Saussele, T.[2018]

In a study involving six patients with brain tumor-related epilepsy (BTRE) who completed four months of treatment with lacosamide (LCM), the drug showed good efficacy in seizure control, with one patient becoming seizure-free and four experiencing a reduction in seizure frequency by 50% or more.

Lacosamide had only a mild effect on EEG background activity, indicating that it may not significantly alter brain function while still providing therapeutic benefits for seizure management in BTRE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lacosamide on background eeg activity in brain tumor-related epilepsy patients: A case series study. Maschio, M., Zarabla, A., Maialetti, A., et al.[2021]

Lacosamide was generally well tolerated in adults with cerebrovascular epilepsy etiology (CVEE), with common treatment-emergent adverse events including headache, dizziness, and fatigue, reported by 74.1% of patients on lacosamide.

In terms of efficacy, a higher proportion of patients on lacosamide completed 6 and 12 months of treatment without seizures compared to those on carbamazepine-CR, and during monotherapy, 56.7% of patients were 50% responders, with 20% achieving seizure freedom.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lacosamide in patients with epilepsy of cerebrovascular etiology. Rosenow, F., Brandt, C., Bozorg, A., et al.[2020]

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 RNS® System offers a promising treatment for patients with refractory partial onset seizures, achieving a 44% reduction in seizures at one year, which improves to 60-66% over three to six years.

This closed-loop brain stimulation method does not negatively affect cognitive function or mood, and the risks associated with the device are comparable to those of other implanted medical devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsive Direct Brain Stimulation for Epilepsy. Morrell, MJ., Halpern, C.[2022]

In patients with the RNS System for epilepsy, a significant reduction in 'long episodes' of electrographic seizures within the first week of starting new antiseizure drugs (ASDs) was highly predictive of the medication's efficacy.

In a larger multicenter study, a decrease in 'episode starts' by 50% or more within the first 1-2 weeks was 90% specific for effective medications, suggesting that early neurophysiological data can guide quicker medication adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection rate changes from a brain-responsive neurostimulation system predict efficacy of newly added antiseizure drugs. Quraishi, IH., Mercier, MR., Skarpaas, TL., et al.[2021]

In a study of 21 epilepsy patients taking lacosamide, the concentration of the drug in cerebrospinal fluid (CSF) was found to be approximately 85% of that in serum, indicating that serum levels can effectively reflect CNS exposure.

The study demonstrated a strong correlation between CSF and serum concentrations of lacosamide, suggesting that monitoring serum levels could be a reliable method for assessing drug exposure in the central nervous system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of lacosamide concentrations in cerebrospinal fluid and serum in patients with epilepsy. May, TW., Brandt, C., Helmer, R., et al.[2018]

A dosing scheme using valproate sodium injection (VPA-IV) followed by divalproex sodium extended-release (VPA-ER) was developed for 42 patients in an epilepsy monitoring unit, allowing for rapid initiation of therapy without increasing seizure risk.

The treatment was well tolerated, with only mild side effects reported, and all patients showed improved seizure control within a week after discharge, indicating the efficacy of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful initiation of combined therapy with valproate sodium injection and divalproex sodium extended-release tablets in the epilepsy monitoring unit. Boggs, JG., Preis, K.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8083819/

Evidence of state-dependence in the effectiveness ... In clinical trials, RNS System treatment results in median seizure frequency reduction of 75% after nine years [1,2]. However, therapeutic ...

2. neuropace.com neuropace.com/blog/epilepsy-treatment-rns-system-epilepsy-research-post-approval-study/

Epilepsy Treatment Results with the RNS System New study shows the RNS System helps reduce seizures by 62% within the first 6 months in adults with drug-resistant focal epilepsy.

3. neuropace.com neuropace.com/press-release/neuropace-rns-system-seizure-reduction-new-data/

New Published Data Show NeuroPace's RNS® System ... New Published Data Show NeuroPace's RNS® System Provides Patients with Unprecedented Seizure Reduction and Improved Quality of Life · Real-World ...

4. neuropace.com neuropace.com/press-release/new-data-aes-2019-neuropace-rns-system/

New Data Presented at the American Epilepsy Society ... Results from the multicenter, retrospective study of 150 patients showed that patients receiving the RNS System experienced 67% median seizure ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000212230

Multicenter Post-approval Study of the RNS System in ... Data from 255 participants were included in the primary effectiveness endpoint. The reduction in seizures overall was 82% (1st quartile 100%; 3 ...

6. neuropace.com neuropace.com/providers/rns-system-safety-data/

RNS System | Proven Safety Profile Patients treated with the RNS System have a statistically significantly lower rate of SUDEP than a comparable refractory population.1. Read More About Lower ...

7. neuropace.com neuropace.com/patients/neuropace-rns-system/

NeuroPace RNS System | Focal Epilepsy Treatment Device 35% of patients achieved ≥ 90% seizure frequency reduction*; 28% of patients had at least one ≥ 6 month period with no seizures. *during last 6 months of follow ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4233950/

Final results of the RNS System Pivotal trial - PMC The median percent reduction in seizures in the OLP was 44% at 1 year and 53% at 2 years, which represents a progressive and significant improvement with time ( ...