25 Participants Needed

Deep Brain Stimulation for Epilepsy

SP
JH
Overseen ByJaison Hampson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 the treatment RNS/DBS activation for epilepsy?

Research shows that responsive neurostimulation (RNS) can significantly reduce seizures in people with epilepsy who do not respond to medication. In a long-term study, 60% of patients experienced a 50% or greater reduction in seizures, and 16% became seizure-free. Additionally, deep brain stimulation (DBS) has been used in Europe for difficult-to-treat epilepsy with similar success rates.12345

Is deep brain stimulation for epilepsy safe for humans?

The RNS System, a type of deep brain stimulation for epilepsy, has been approved by the FDA based on safety data from clinical trials. While it is generally considered safe, some complications have been reported, such as cerebral vasospasm (narrowing of blood vessels in the brain). More research is needed to fully understand all potential side effects.56789

How is the RNS/DBS treatment for epilepsy different from other treatments?

The RNS/DBS treatment for epilepsy is unique because it uses a device that detects abnormal brain activity and delivers electrical stimulation directly to the seizure focus to prevent seizures. Unlike medications that affect the whole brain, this treatment targets specific areas, making it suitable for patients who do not respond to drugs or cannot undergo surgery.12101112

What is the purpose of this trial?

The purpose of this study is to map the acute, short-term cortical evoked responses to thalamic electrical stimulation in persons with intractable epilepsy

Research Team

SP

Sandipan Pati, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for individuals with intractable epilepsy who are already receiving neuromodulation therapy (like DBS or RNS) and are monitored at an outpatient epilepsy clinic. It's not suitable for pregnant women, those with recent severe mental health issues, an IQ below 70, or anyone unwilling to share their medical records for research.

Inclusion Criteria

I am receiving therapy with an implanted device for nerve stimulation.
I have been diagnosed with epilepsy.
Followed in the outpatient epilepsy clinic

Exclusion Criteria

Do not agree to share their medical records for research purposes
Pregnant women
Intelligence quotient (IQ) less than 70 as measured by clinical neuropsychological evaluation
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive thalamic electrical stimulation to map cortical evoked responses

Short-term (approximately 20 minutes)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • RNS/DBS activation
Trial Overview The study aims to understand the immediate brain response to thalamic electrical stimulation provided by implanted devices in patients with difficult-to-treat epilepsy. This could help improve therapeutic outcomes of deep brain stimulation.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention

RNS/DBS activation is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as RNS System for:
  • Partial-onset seizures with one or two seizure onset zones in adults with epilepsy who have not been controlled with two or more antiepileptic drugs
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as DBS Therapy for:
  • Focal seizures in adults with epilepsy who have not been responsive to two or more antiepileptic drugs and could not be treated with other types of epilepsy surgery
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as DBS Therapy for:
  • Refractory epilepsy in adults

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Findings from Research

Responsive neurostimulation (RNS) directly targets seizure foci using electrocorticography (ECoG) patterns, making it a promising option for patients with drug-resistant epilepsy who cannot undergo surgery.
Other devices like the AspireSR vagal nerve stimulator and deep brain stimulation of the anterior thalamus show similar efficacy in managing intractable epilepsy, highlighting the potential of various stimulation techniques in improving patient outcomes.
Responsive brain stimulation in epilepsy.Hartshorn, A., Jobst, B.[2023]
The NeuroPaceยฎ RNSยฎ 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.
The RNS System: brain-responsive neurostimulation for the treatment of epilepsy.Jarosiewicz, B., Morrell, M.[2021]
The RNSยฎ System, which uses closed-loop responsive neurostimulation, significantly reduces the frequency of disabling seizures in adults with medically intractable focal seizures, achieving median reductions of 75% after 9 years of treatment.
This treatment is well tolerated and not only improves seizure control but also enhances quality of life and cognitive function, while providing valuable data for ongoing epilepsy management and research.
Brain-responsive neurostimulation for epilepsy (RNS® System).Skarpaas, TL., Jarosiewicz, B., Morrell, MJ.[2019]

References

Responsive brain stimulation in epilepsy. [2023]
The RNS System: brain-responsive neurostimulation for the treatment of epilepsy. [2021]
Brain-responsive neurostimulation for epilepsy (RNS® System). [2019]
Responsive Neurostimulation Targeting the Anterior, Centromedian and Pulvinar Thalamic Nuclei and the Detection of Electrographic Seizures in Pediatric and Young Adult Patients. [2022]
Electrostimulation for Refractory Epilepsy: A Review. [2018]
Vasospasm secondary to responsive neurostimulator placement: a previously unreported complication. Illustrative case. [2023]
Real-world experience with direct brain-responsive neurostimulation for focal onset seizures. [2021]
The RNS System: responsive cortical stimulation for the treatment of refractory partial epilepsy. [2014]
Characterizing Complications of Intracranial Responsive Neurostimulation Devices for Epilepsy Through a Retrospective Analysis of the Federal MAUDE Database. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Robot-Assisted Responsive Neurostimulator System Placement in Medically Intractable Epilepsy: Instrumentation and Technique. [2020]
11.United Statespubmed.ncbi.nlm.nih.gov
Robotic Orthogonal Implantation of Responsive Neurostimulation (RNS) Depth Electrodes in the Mesial Temporal Lobe: Case Series. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
A Novel Robotic-Assisted Technique to Implant the Responsive Neurostimulation System. [2021]
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