Deep Brain Stimulation for Epilepsy

(EPI-BOOST Trial)

Overseen By Lutz Weise, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Lack of consent, MRI preclusion, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to evaluate the effectiveness of objective neural response feedback on deep brain stimulation (DBS) programming for drug-resistant epilepsy in a prospective observational cohort study.

Do I need to stop my current medications for the trial?

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 the treatment Neuromodulation programming for epilepsy?

Deep brain stimulation (DBS) has shown benefits in treating epilepsy, especially in cases where other treatments have failed. Studies have found that DBS can help reduce seizures, particularly when targeting specific brain areas like the anterior nucleus of the thalamus (ANT) and the hippocampus. Additionally, combining DBS with other treatments like vagus nerve stimulation (VNS) may enhance its effectiveness. ^{1 2 3 4 5}

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS) is generally considered safe, but it can have complications. Overall, about 25% of patients may experience complications, with 4-6% having lasting neurological issues. The risk of seizures after DBS is low, estimated at less than 2.4%, and even lower for long-term stimulation. ^{6 7 8 9 10}

How is deep brain stimulation different from other treatments for epilepsy?

Deep brain stimulation (DBS) for epilepsy is unique because it involves delivering electrical impulses to specific deep brain areas to reduce seizures, especially in patients who cannot undergo surgery. Unlike medications, DBS targets brain circuits directly, and its effectiveness can increase over time, although the exact mechanisms are still being studied. ^{1 9 11 12 13}

Research Team

Lutz Weise, MD, PhD

Principal Investigator

Dalhousie University

Eligibility Criteria

This trial is for individuals with drug-resistant epilepsy who have consented to participate and qualify for deep brain stimulation (DBS). It's not suitable for those who cannot undergo an MRI due to electrical or other devices in their body.

Inclusion Criteria

Informed consent

My epilepsy does not improve with medication.

Exclusion Criteria

Lack of consent

Electrical or other devices that preclude the performance of an MRI for pre-operative imaging

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive deep brain stimulation (DBS) programming tailored based on neuronal activity to manage drug-resistant epilepsy

12 months

Regular visits for DBS programming and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of seizure reduction and quality of life

4 weeks

Treatment Details

Interventions

• Neuromodulation programming

Trial Overview The study is testing how effective it is to use objective neural response feedback when setting up DBS programming for managing drug-resistant epilepsy, in a forward-looking observational group of patients.

Participant Groups

Group I: Participant Group Experimental Treatment 1 Intervention

Participants who meet eligibility criteria and provide informed consent.

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Findings from Research

Deep brain stimulation (DBS) is a safe and effective treatment for movement disorders and is increasingly being used for medically refractory epilepsy, showing promise in seizure control.

Recent advancements in understanding epileptogenic networks and improved trial designs have enhanced the evidence supporting DBS for epilepsy, although the exact mechanisms and optimal stimulation parameters are still being researched.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for the treatment of epilepsy: circuits, targets, and trials. Laxpati, NG., Kasoff, WS., Gross, RE.[2021]

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

Deep brain stimulation (DBS) targeting the anterior nucleus of the thalamus (ANT) and hippocampus (HC) has been shown to significantly reduce seizure frequency in drug-resistant epilepsy, with about 50% of patients experiencing a 46%-90% reduction with ANT-DBS and a 48%-95% reduction with HC-DBS.

Approximately 75% of patients receiving stimulation from ANT, HC, or centromedian nucleus of the thalamus (CMT) report at least a 50% reduction in seizures, with factors like the absence of structural brain abnormalities and specific seizure types influencing the effectiveness of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for drug-resistant epilepsy. Li, MCH., Cook, MJ.[2018]

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal non-invasive deep-brain stimulation with temporal interference for the suppression of epileptic biomarkers. Acerbo, E., Jegou, A., Luff, C., et al.[2022]

References

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

Deep brain stimulation for the treatment of epilepsy: circuits, targets, and trials. [2021]

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

Deep Brain Stimulation for Epilepsy: Biomarkers for Optimization. [2020]

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

Is thalamic deep brain stimulation synergistic with vagus nerve stimulation in drug-resistant genetic generalized epilepsy? [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Refractory Temporal Lobe Epilepsy. Current Status and Future Trends. [2023]

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

Improving the effectiveness of ANT DBS therapy for epilepsy with optimal current targeting. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. [2007]

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

Deep brain stimulation for drug-resistant epilepsy. [2018]

8. England pubmed.ncbi.nlm.nih.gov

The incidence of seizures following Deep Brain Stimulating electrode implantation for movement disorders, pain and psychiatric conditions. [2022]

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

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

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

Deep brain stimulation of thalamus for epilepsy. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for epilepsy. [2013]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Focal non-invasive deep-brain stimulation with temporal interference for the suppression of epileptic biomarkers. [2022]

13. Austria pubmed.ncbi.nlm.nih.gov

Rationale, mechanisms of efficacy, anatomical targets and future prospects of electrical deep brain stimulation for epilepsy. [2019]