Brain Stimulation for Epilepsy
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mayo Clinic
Disqualifiers: No follow-up expected
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
A primary purpose of this study is to better understand what stimulation parameters work best for patients. For example, for Deep Brain Stimulation (DBS) of the Anterior Nucleus of the Thalamus (ANT), it is not clear what stimulation frequency leads is most effective. This study will help assess the effectiveness of low frequency or high frequency stimulation.
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 Deep Brain Stimulation (DBS) for epilepsy?
Deep Brain Stimulation (DBS) has shown promising results in reducing seizures for people with epilepsy that doesn't respond to medication. Studies indicate that targeting specific brain areas, like the anterior nucleus of the thalamus, can help decrease seizure frequency and improve quality of life.12345
Is deep brain stimulation (DBS) safe for humans?
How does the treatment Deep Brain Stimulation (DBS) for epilepsy differ from other treatments?
Deep Brain Stimulation (DBS) is unique because it involves implanting a device that sends electrical impulses to specific brain areas to control seizures, especially for patients who don't respond to medication or surgery. Unlike other treatments, DBS is minimally invasive and reversible, offering a new option for those with drug-resistant epilepsy.1291011
Eligibility Criteria
This trial is for individuals with seizures or epilepsy. Participants should be candidates for Deep Brain Stimulation (DBS) and specifically targeting the Anterior Nucleus of the Thalamus (ANT). The study will exclude certain people, but those details are not provided here.Inclusion Criteria
I have a brain stimulation device implanted for epilepsy.
Exclusion Criteria
Patients for whom clinical follow-up is not expected during the initial 6-8 months following implant
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Deep Brain Stimulation (DBS) with varying frequency parameters to assess effectiveness
12 months
Regular visits for monitoring and adjustment
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 months
Treatment Details
Interventions
- Stimulation Set A and B (Procedure)
Trial OverviewThe study is testing two different sets of stimulation parameters, referred to as Set A and B, to determine which frequency is more effective in controlling seizures when using DBS on the ANT.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Stimulation set B/A groupExperimental Treatment1 Intervention
Device will be set to use stimulation parameters from set B first (e.g. low frequency stimulation) and then from set A (e.g. 145 Hz).
Group II: Stimulation set A/B groupExperimental Treatment1 Intervention
Device will be set to use stimulation parameters from set A first (e.g. 145 Hz) and then from set B (e.g. low frequency stimulation).
Stimulation Set A and B is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Deep Brain Stimulation for:
- Parkinson's disease
- Essential tremor
- Dystonia
- Epilepsy
- Obsessive-compulsive disorder
🇺🇸 Approved in United States as Deep Brain Stimulation for:
- Parkinson's disease
- Essential tremor
- Dystonia
- Epilepsy
- Obsessive-compulsive disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
References
Deep brain stimulation for drug-resistant epilepsy. [2018]To review clinical evidence on the antiepileptic effects of deep brain stimulation (DBS) for drug-resistant epilepsy, its safety, and the factors influencing individual outcomes.
Defining the anterior nucleus of the thalamus (ANT) as a deep brain stimulation target in refractory epilepsy: Delineation using 3 T MRI and intraoperative microelectrode recording. [2022]Deep brain stimulation (DBS) is a minimally invasive and reversible method to treat an increasing number of neurological and psychiatric disorders, including epilepsy. Targeting poorly defined deep structures is based in large degree on stereotactic atlas information, which may be a major source of inconsistent treatment effects.
Experience and consensus on stimulation of the anterior nucleus of thalamus for epilepsy. [2022]Deep brain stimulation of the anterior nuclei of thalamus (ANT-DBS) is effective for reduction of seizures, but little evidence is available to guide practitioners in the practical use of this therapy. In an attempt to fill this gap, a questionnaire with 37 questions was circulated to 578 clinicians who were either engaged in clinical trials of or known users of DBS for epilepsy, with responses from 141, of whom 58.2% were epileptologists and 28.4% neurosurgeons. Multiple regions of the world were represented. The survey found that the best candidates for DBS were considered those with temporal or frontal seizures, refractory to at least two medicines. Motivations for renewing therapy upon battery depletion were reduced convulsive, impaired awareness, and severe seizures and improved quality of life. Targeting of leads mainly was by magnetic resonance imaging, sometimes with intraoperative imaging or microelectrode recording. The majority used transventricular approaches. Stimulation parameters mostly imitated the SANTE study parameters, except for initial stimulation amplitudes in the 2-3-V or -mA range, versus 5 V in the SANTE study. Stimulation intensity was most often increased or reduced, respectively, for lack of efficacy or side effects, but changes in active contacts, cycle time, and pulse duration were also employed. Mood or memory problems or paresthesias were the side effects most responsible for adjustments. Off-label sites stimulated included centromedian thalamus, hippocampus, neocortex, and a few others. Several physicians used DBS in conjunction with vagus nerve stimulation or responsive neurostimulation, although our study did not track efficacy for combined use. Experienced users varied more from published parameters than did inexperienced users. In conclusion, surveys of experts can provide Class IV evidence for the most prevalent practical use of ANT-DBS. We present a flowchart for one protocol combining common practices. Controlled comparisons will be needed to choose the best approach.
Deep brain stimulation for intractabile epilepsy. [2022]Deep brain stimulation (DBS) is currently considered a promising neuromodulation therapy for refractory epilepsy not suitable for resective surgery. Several anatomical targets and different stimulation approaches have been proposed in order to obtain satisfactory seizures reduction. As expected, according with different patterns of neural pathways involvement, the efficacy of each anatomical target stimulation in reducing seizure frequency varies among the different epileptic syndromes.
Deep brain stimulation for the treatment of epilepsy. [2009]During the last decade, deep brain stimulation (DBS) has been used to treat several neurologic disorders, including epilepsy. Promising results have been reported with stimulation in different brain regions. At present however, several issues remain unanswered. As an example, it is still unclear whether particular seizure types and syndromes should be treated with DBS in different targets or with different stimulation parameters. In addition, clinical, electrophysiological and anatomical features capable of predicting a good postoperative outcome are still unknown. We review the published literature on DBS, cortical and cerebellar stimulation for the treatment of epilepsy focusing predominantly on the rationale and clinical outcome in each target.
Surgical-Related and Hardware-Related Adverse Effects of Deep Brain Stimulation: A Retrospective Single-Center Analysis. [2022]To review both the surgical-related, and hardware-related adverse effects of deep brain stimulation (DBS) in a single center over the last five years.
Deep brain stimulation for epilepsy. [2019]The efficacy and safety of deep brain stimulation (DBS) of the anterior nucleus of the thalamus (ANT) for epilepsy (SANTE) trial was demonstrated by a randomized trial by Fisher et al. (2010). Based on this trial, the U.S. Food and Drug Administration recently granted approval for DBS therapy for epilepsy; the indication is as follows: "Bilateral stimulation of the anterior nucleus of the thalamus (ANT) for epilepsy is indicated as an adjunctive therapy for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial onset seizures with or without secondary generalization that are refractory to three or more antiepileptic medications". This paper reviews the experimental data and the clinical experience using DBS for the treatment of epilepsy. "This article is part of the Supplement issue Neurostimulation for Epilepsy."
Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]The number of deep brain stimulation (DBS) procedures is rapidly rising as well as the novel indications. Reporting adverse events related to surgery and to the hardware used is essential to define the risk-to-benefit ratio and develop novel strategies to improve it.
Deep brain stimulation for refractory epilepsy. [2021]Deep brain stimulation (DBS) is a method of treatment utilized to control medically refractory epilepsy (RE). Patients with medically refractory epilepsy who do not achieve satisfactory control of seizures with pharmacological treatment or surgical resection of the epileptic focus and those who do not qualify for surgery could benefit from DBS. The most frequently used stereotactic targets for DBS are the anterior thalamic nucleus, subthalamic nucleus, central-medial thalamic nucleus, hippocampus, amygdala and cerebellum. The DBS is believed to be an effective method of treatment for various types of epilepsy among adults and adolescents. Side effects may be associated with implantation of electrodes and with the stimulation itself. An increasing number of publications and growing interest in DBS application for RE may result in standardization of the qualification and treatment protocol for RE with DBS.
[Deep brain stimulation in drug-resistant epilepsy]. [2021]Deep brain stimulation (DBS) in drug-resistant epilepsy has been applied to several brain targets. However, its exact mechanism of action is not known, and the diversity of targets makes it difficult to know the degree of evidence that supports its use.
Refractory epilepsy and deep brain stimulation. [2011]Up to one-third of all patients with epilepsy have epilepsy refractory to medical therapy. Surgical options include temporal lobectomy, focal neocortical resection, stereotactic lesioning and neurostimulation. Neurostimulatory options comprise vagal nerve stimulation, trigeminal nerve stimulation and deep brain stimulation (DBS). DBS enables structures in the brain to be stimulated electrically by an implanted pacemaker after a minimally invasive neurosurgical procedure and has become the therapy of choice for Parkinson's disease refractory to or complicated by drug therapy. Here we review DBS for epilepsy, a powerful emerging treatment in the surgical armamentarium for drug refractory epilepsy, with a focus on extratemporal epilepsy.