20 Participants Needed

DBS Parameter Optimization for Epilepsy

AJ
Overseen ByAlec Jonason
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Minnesota
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 is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for epilepsy?

Deep brain stimulation (DBS) has shown promise in reducing seizures for people with epilepsy who do not respond to medication. Studies have demonstrated that DBS can modulate brain circuits and decrease the abnormal brain activity associated with seizures, leading to a reduction in seizure frequency.12345

Is deep brain stimulation (DBS) generally safe for humans?

Deep brain stimulation (DBS) has been used in humans for various conditions, including epilepsy and Parkinson's disease. While it is generally considered safe, there can be complications related to the surgery and the device itself, as reported in studies involving a large number of cases.15678

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

Deep Brain Stimulation (DBS) for epilepsy is unique because it involves implanting a device that sends electrical impulses to specific brain areas to reduce seizures, especially in patients who do not respond to medications. Unlike traditional treatments, DBS can be adjusted in real-time to optimize its effects, and it offers a reversible and minimally invasive option for managing epilepsy.145910

What is the purpose of this trial?

Deep brain stimulation (DBS) is used to treat epilepsy in cases where patients are medically refractory and are not candidates for surgical resection. This therapy has been shown to be effective in seizure reduction, yet very few patients achieve the ultimate goal of seizure freedom. Implantable neural stimulators (INSs) have many parameters that may be adjusted, and could be tuned to achieve very patient specific therapies. This study will develop a platform for stimulation setting optimization based on power spectral density (PSD) measures.

Research Team

RM

Robert McGovern, MD

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for patients with epilepsy that doesn't respond to medication and who already have a deep brain stimulator implanted. It's not suitable for individuals with severe dementia as determined by the study investigator.

Inclusion Criteria

My epilepsy does not improve with medication.
Patients who already have a deep brain stimulator in place

Exclusion Criteria

Patients with severe dementia at investigator discretion

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive deep brain stimulation with optimized parameters based on power spectral density measures

12 months
Regular in-clinic visits for parameter adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Implantable Neural Stimulators (INSs)
Trial Overview The study tests how changing settings on an implantable neural stimulator can better control seizures in epilepsy patients. Different orders of stimulation (PS and OS) are being compared to find the most effective parameter adjustments.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Stimulation Group CExperimental Treatment1 Intervention
Participants with already implanted DBS will receive stimulation order 1. OS, OS, PS.
Group II: Stimulation Group BExperimental Treatment1 Intervention
Participants with already implanted DBS will receive stimulation order 1. OS, PS, OS.
Group III: Stimulation Group AExperimental Treatment1 Intervention
Participants with already implanted DBS will receive stimulation order 1. PS, OS, OS.

Implantable Neural Stimulators (INSs) is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Medtronic DBS System for:
  • Focal-onset seizures with or without focal to bilateral seizures in adults who have not responded to three or more antiseizure medications
🇪🇺
Approved in European Union as Deep Brain Stimulation (DBS) devices for:
  • Epilepsy in adults with focal-onset seizures who have not achieved adequate seizure control despite appropriate trials of antiepileptic medication

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Findings from Research

Deep brain stimulation (DBS) targeting the anterior nucleus of thalamus (ANT) for epilepsy can be effectively visualized using 3 T MRI, allowing for better anatomical delineation of the target area.
There is significant individual variation in the location of ANT among patients, making direct targeting more effective than indirect methods; however, microelectrode recording (MER) alone may not provide reliable localization without detailed imaging.
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.Möttönen, T., Katisko, J., Haapasalo, J., et al.[2022]
Temporal Interference (TI) stimulation at 130 Hz non-invasively stimulates the hippocampus, leading to increased physiological brain activity (ripples) and decreased harmful brain activity (Fast Ripples and interictal discharges) in mouse models of epilepsy.
TI stimulation shows better penetration into the human hippocampus compared to traditional transcranial current stimulation (TCS), suggesting its potential as a focused therapeutic approach for treating epilepsy without affecting surrounding brain tissue.
Focal non-invasive deep-brain stimulation with temporal interference for the suppression of epileptic biomarkers.Acerbo, E., Jegou, A., Luff, C., et al.[2022]
Deep brain stimulation (DBS) is a safe and effective treatment for refractory epilepsy, as it can modulate brain circuits and reduce the abnormal neuronal activity associated with seizures.
The video outlines the importance of precise surgical planning and targeting of specific brain nuclei (anterior thalamus, centromedian thalamus, and hippocampus) to optimize DBS outcomes, highlighting that each target has unique advantages and challenges.
Deep Brain Stimulation for Treatment of Refractory Epilepsy.de Oliveira, TVHF., Cukiert, A.[2022]

References

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]
Focal non-invasive deep-brain stimulation with temporal interference for the suppression of epileptic biomarkers. [2022]
Deep Brain Stimulation for Treatment of Refractory Epilepsy. [2022]
Deep brain stimulation for intractabile epilepsy. [2022]
Sensing-enabled hippocampal deep brain stimulation in idiopathic nonhuman primate epilepsy. [2015]
Brain stimulation for epilepsy--local and remote modulation of network excitability. [2019]
Deep brain stimulation for drug-resistant epilepsy. [2018]
Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]
Deep Brain Stimulation for Treatment of Refractory Epilepsy. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Effects of hippocampal low-frequency stimulation in idiopathic non-human primate epilepsy assessed via a remote-sensing-enabled neurostimulator. [2018]
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