Deep Brain Stimulation for Epilepsy

Overseen By Karla Crockett

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Drug or alcohol use, others

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

Compensation: Varies

Number of Visits: Unknown

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to detect seizures in individuals with medication-resistant epilepsy. The study uses a deep brain stimulation system, a device implanted in the brain, to monitor seizures and compares the results to standard hospital tests. It suits individuals who have had a deep brain stimulator implanted for epilepsy. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance seizure detection methods.

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 study team or your doctor.

What prior data suggests that this deep brain stimulation system is safe for thalamus seizure detection?

Research has shown that deep brain stimulation (DBS) for epilepsy is generally safe. Studies have found that long-term DBS can significantly reduce seizures in people with epilepsy. For example, one study reported a seizure reduction of about 64% to 69%, with over 61% of patients responding well to the treatment. This indicates that most patients experienced fewer seizures over time.

Additionally, patients usually tolerate the treatment well. While side effects can occur, they are often manageable. DBS has also been used successfully in other cases of epilepsy that do not respond to medication, suggesting it is relatively safe. For concerns, it is advisable to consult the trial team for more detailed information on what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Deep Brain Stimulation (DBS) system for epilepsy because it offers a novel approach to managing seizures. Unlike traditional treatments like anti-seizure medications, which can have widespread effects on the brain, this system targets specific brain regions. The DBS system detects seizures using a device implanted in the thalamus, potentially providing real-time intervention and reducing seizure frequency. This precision targeting is particularly promising for patients who haven't responded well to existing therapies, offering hope for improved quality of life with fewer side effects.

What evidence suggests that thalamus seizure detection with a deep brain stimulator system is effective for epilepsy?

Research has shown that deep brain stimulation (DBS) can significantly reduce the frequency and severity of seizures in people with epilepsy. In this trial, participants will receive thalamus seizure detection with a DBS system. Studies have found that targeting the anterior thalamus with DBS can lead to a 69% reduction in seizure frequency. Another review found that DBS in the anterior and centromedian parts of the brain reduced seizures by about 64% and 69%, respectively. These findings suggest that DBS is a promising treatment for individuals whose epilepsy does not respond to medication. Overall, DBS not only reduces seizure frequency but also continues to improve over time, making it an effective treatment for epilepsy. ^{1 3 4 6 7}

Who Is on the Research Team?

Nicholas Gregg

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for a small group of 5 patients with drug-resistant epilepsy. Participants must be eligible for in-patient video EEG monitoring to validate seizure detection via thalamus activity.

Inclusion Criteria

I understand the study procedures and can follow them throughout the study.

Participants must be implanted with a clinical DBS system for epilepsy with brain recording capabilities (Medtronic Percept™ DBS)

Exclusion Criteria

Health status or any clinical conditions that, in the opinion of the site investigator, would pose undue risk to undergo epilepsy monitoring unit evaluation for the purpose of seizure characterization

Women must verify not pregnant and, if applicable, have a urine pregnancy test

Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

In-patient Monitoring

Participants undergo in-patient monitoring with video-EEG to validate thalamus seizure detection using a DBS system

2-4 weeks

In-patient stay

Ambulatory Monitoring

Participants are monitored for thalamus seizure detection using a DBS system in an ambulatory setting

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Thalamus Seizure Detection with Deep Brain Stimulator System

Trial Overview The study aims to test the accuracy of detecting seizures through thalamus activity, using a deep brain stimulator system alongside standard video EEG monitoring.

How Is the Trial Designed?

Group I: Thalamus seizure detection with a DBS system Experimental Treatment 2 Interventions

Thalamus seizure detection by a DBS system, validated with concurrent in-hospital gold standard video EEG monitoring.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Deep brain stimulation (DBS) of the anterior nuclei of thalamus is considered effective for reducing seizures, particularly in patients with temporal or frontal seizures that do not respond to at least two medications, based on a survey of 141 clinicians.

The survey revealed that most clinicians adjust stimulation parameters based on patient response, with common side effects like mood changes and memory issues influencing these adjustments, highlighting the need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience and consensus on stimulation of the anterior nucleus of thalamus for epilepsy. Fasano, A., Eliashiv, D., Herman, ST., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11791334/

Effect of deep brain stimulation on the severity of seizures ... Post-operative data revealed significantly reduced seizure frequency, duration, and severity scores. Notably, this reduction was more pronounced ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06700356

Thalamus Seizure Detection With a Deep Brain Stimulator ... The sensitivity, specificity, and false alarm rate of thalamus seizure detection will be calculated using recordings from a deep brain stimulation system, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0920121125001081

Deep brain stimulation for epilepsy: A systematic review ... Overall seizure reduction was 64.28 % for the anterior nucleus (ANT) and 69.11 %for the centromedian nucleus (CMN). •. Overall responder rates were 61.51 % for ...

4. europe.medtronic.com europe.medtronic.com/xd-en/healthcare-professionals/therapies-procedures/neurological/deep-brain-stimulation/indications/epilepsy/clinical-outcomes.html

CLINICAL OUTCOMES: EPILEPSY Deep Brain Stimulation EFFECTIVENESS RESULTS · REDUCED SEIZURE FREQUENCY. DBS for Epilepsy was shown to reduce median seizure frequency, and these results improved over time. · FREEDOM ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000001334

Long-term efficacy and safety of thalamic stimulation for ... Anterior thalamic stimulation is associated with a 69% reduction in seizure frequency and a 34% serious device-related adverse event rate at 5 years.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4352097/

Long-term efficacy and safety of thalamic stimulation for ... Long-term deep brain stimulation (DBS) for epilepsy showed a sustained and statistically significant seizure frequency reduction from baseline after 1, 2, 3 ...

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000206887

Deep Brain Stimulation of the Anterior Nucleus ... This study provides Class IV evidence that ANT DBS reduces the frequency of seizures in patients with drug-resistant focal epilepsy. Discussion.