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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of deep brain stimulation, which sends electrical pulses to the brain, for individuals with drug-resistant epilepsy. The researchers aim to determine if providing doctors with additional feedback on the brain’s responses can enhance neuromodulation programming, the process of adjusting electrical stimulation settings. This study suits those with epilepsy unresponsive to medication who are considering deep brain stimulation. Participants must consent and cannot have devices that prevent an MRI scan. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research that could improve epilepsy treatment options.

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 prior data suggests that this neuromodulation programming is safe for epilepsy patients?

Research has shown that deep brain stimulation (DBS) is generally safe and effective for treating epilepsy that doesn't improve with medication. In past studies, DBS greatly reduced the frequency and duration of seizures, suggesting it could help people experience fewer and shorter seizures over time.

Reports indicate that patients usually tolerate DBS well. For example, one study found many people responded positively to the treatment. Additionally, the Medtronic DBS System for Epilepsy has demonstrated safety, reassuring those considering this option. It has already been approved for treating epilepsy, confirming its well-established safety.

Overall, DBS has shown promising results for people with drug-resistant epilepsy, with evidence supporting its safety and potential benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard epilepsy treatments, such as anti-seizure medications and surgical interventions, deep brain stimulation (DBS) offers a unique approach by directly modulating brain activity. While most treatments aim to suppress symptoms, DBS targets the source of the seizures by delivering electrical impulses to specific brain areas. Researchers are excited about DBS because it has the potential to provide more precise control over seizures with fewer side effects, offering hope for patients who haven't found relief with current therapies.

What evidence suggests that neuromodulation programming is effective for epilepsy?

Research has shown that deep brain stimulation (DBS) effectively reduces seizures in people whose epilepsy does not respond to medication. For example, one study found a 64% reduction in seizures when targeting the anterior nucleus and a 69% reduction when targeting the centromedian nucleus. Another study demonstrated that DBS reduced the number of seizures from 16 per month to about 8 per month over five years. After six months of DBS, seizure reduction rates ranged from 14% to 75%, with an average reduction of 41%. These findings suggest that DBS can significantly lower the number of seizures and improve the quality of life for people with epilepsy. Participants in this trial will receive neuromodulation programming as part of the DBS treatment to further evaluate its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Lutz Weise, MD, PhD

Principal Investigator

Dalhousie University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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) 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 (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]

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]

Citations

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

Effect of deep brain stimulation on the severity of seizures ... DBS reduced seizure frequency and duration in DRE over a 6-month follow-up. SSQ decreased progressively over time, indicating long-term ...

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11656455/

The Evolving Landscape of DBS in Epilepsy - PMC The 5-year follow-up cohort had a median seizure frequency reduction from 16 per month at baseline to 7.9 per month at 5-year follow up (P < .

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. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923008760

Deep Brain Stimulation for the Treatment of Epilepsy At the end of the 6-month unblinded stimulation period, the mean seizure reduction rate was 41 % (range 14–75 %). Statistical analysis demonstrated a ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf

P960009/S478 Summary of Safety and Effectiveness (SSED) The Medtronic DBS System for Epilepsy has demonstrated safety ... adaptive deep brain stimulation (aDBS) for Parkinson's Disease in existing devices in the.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39534832/

Assessment of the Efficacy of Deep Brain Stimulation (DBS ... Deep brain stimulation (DBS) is a promising alternative, showing effectiveness in reducing seizures for some patients. This systematic review ...