Deep Brain Stimulation for Epilepsy
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive thalamic electrical stimulation to map cortical evoked responses
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- RNS/DBS activation
RNS/DBS activation is already approved in United States, European Union for the following indications:
- 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
- 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
- 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