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

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 study team or your doctor.

What data supports the effectiveness of the treatment Thalamus Seizure Detection with Deep Brain Stimulator System for epilepsy?

Research shows that deep brain stimulation (DBS) of the anterior thalamus can effectively reduce seizures in patients with epilepsy, especially those who do not respond to medication. Studies have demonstrated that signals from DBS electrodes are more reliable than traditional EEG for predicting and detecting seizures, with high accuracy and low false-alarm rates. ^{1 2 3 4 5}

Is deep brain stimulation for epilepsy safe for humans?

Deep brain stimulation of the anterior thalamus has been studied for safety in people with epilepsy. Common side effects include local infections, sensory disturbances, and issues with the device like battery failure, which can affect seizure control. Overall, it has been considered safe for long-term use, but regular device checks are important to prevent complications. ^{1 6 7 8 9}

How is the Thalamus Seizure Detection with Deep Brain Stimulator System treatment different from other epilepsy treatments?

This treatment is unique because it uses deep brain stimulation (DBS) to target the anterior thalamus, which helps detect and predict seizures more accurately than traditional scalp EEG. It offers a novel approach by potentially delivering therapy only when needed, which can be particularly beneficial for patients with seizures that are hard to localize or control with medication. ^{1 3 4 5 10}

What is the purpose of this trial?

The purpose of this study is to determine the feasibility of chronic ambulatory thalamus seizure detection. The sensitivity, specificity, and false alarm rate of thalamus seizure detection will be calculated using recordings from a deep brain stimulation system, assessed relative to concurrent gold-standard video-EEG monitoring collected in the in-patient setting (epilepsy monitoring unit), in 5 patients with drug resistant epilepsy.

Research Team

Nicholas Gregg

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Subcortical (thalamic) automated seizure detection: A new option for contingent therapy delivery. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Desynchronization of temporal lobe theta-band activity during effective anterior thalamus deep brain stimulation in epilepsy. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Cortical activation with deep brain stimulation of the anterior thalamus for epilepsy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Chronic anterior thalamus stimulation for intractable epilepsy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Prediction and detection of seizures from simultaneous thalamic and scalp electroencephalography recordings. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

De novo status epilepticus possibly related to battery depletion of anterior thalamic brain stimulator. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Electrical stimulation of the anterior nucleus of the thalamus for the treatment of intractable epilepsy. [2022]

8. Denmark pubmed.ncbi.nlm.nih.gov

Anterior thalamic deep brain stimulation in refractory epilepsy: A randomized, double-blinded study. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

The SANTÉ study at 10 years of follow-up: Effectiveness, safety, and sudden unexpected death in epilepsy. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Experience and consensus on stimulation of the anterior nucleus of thalamus for epilepsy. [2022]