Brain Stimulation for Epilepsy

Overseen By Amy Headlee

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: No follow-up expected

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the most effective brain stimulation settings for people with epilepsy using Deep Brain Stimulation (DBS). Researchers are comparing two different stimulation patterns to assess whether low or high frequency is more effective. Participants will have their devices set to either Stimulation Set A first, followed by B, or vice versa. This trial suits individuals already using a brain stimulation device targeting the anterior nucleus of the thalamus. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve treatment options for epilepsy.

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 trial coordinators or your doctor.

What prior data suggests that this brain stimulation technique is safe for epilepsy patients?

Research shows that Deep Brain Stimulation (DBS) is generally safe for people with epilepsy. Studies indicate that this treatment can significantly reduce the number of seizures. For instance, one study reported a 56% decrease in seizures after two years. Another study found a 64.28% reduction in seizures for those who received stimulation in a specific brain area called the anterior nucleus.

The FDA has approved DBS for certain uses, confirming its safety for those conditions. People using DBS for epilepsy have demonstrated positive results in terms of safety and effectiveness. These findings suggest that DBS is generally well-tolerated, though, like any treatment, it can have side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these brain stimulation treatments for epilepsy because they offer a unique approach compared to standard medications or surgical options. Unlike traditional treatments that often focus on altering brain chemistry, these devices use electrical stimulation with specific frequency parameters to manage seizures. Stimulation Set A/B and Set B/A groups vary the order of applying high and low frequency stimulation, which could provide more personalized and effective control of seizures. This method has the potential to offer quicker results and fewer side effects, making it a promising alternative for those who haven't found relief with existing treatments.

What evidence suggests that this trial's treatments could be effective for epilepsy?

Research has shown that deep brain stimulation (DBS) can greatly help people with epilepsy. On average, patients experienced 62% fewer seizures. In another study, about 70% of patients responded well to DBS, showing noticeable improvement. Results often improve over time, with some individuals experiencing over a 60% reduction in seizures after five years. This trial will compare two different stimulation parameter sets: one group will start with Stimulation Set B followed by Set A, while the other group will start with Stimulation Set A followed by Set B. These findings suggest that DBS could be a promising treatment for those dealing with epilepsy. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with seizures or epilepsy. Participants should be candidates for Deep Brain Stimulation (DBS) and specifically targeting the Anterior Nucleus of the Thalamus (ANT). The study will exclude certain people, but those details are not provided here.

Inclusion Criteria

I have a brain stimulation device implanted for epilepsy.

Exclusion Criteria

Patients for whom clinical follow-up is not expected during the initial 6-8 months following implant

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) with varying frequency parameters to assess effectiveness

12 months

Regular visits for monitoring and adjustment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Stimulation Set A and B

Trial Overview The study is testing two different sets of stimulation parameters, referred to as Set A and B, to determine which frequency is more effective in controlling seizures when using DBS on the ANT.

How Is the Trial Designed?

Group I: Stimulation set B/A group Experimental Treatment 1 Intervention

Device will be set to use stimulation parameters from set B first (e.g. low frequency stimulation) and then from set A (e.g. 145 Hz).

Group II: Stimulation set A/B group Experimental Treatment 1 Intervention

Device will be set to use stimulation parameters from set A first (e.g. 145 Hz) and then from set B (e.g. low frequency stimulation).

Stimulation Set A and B is already approved in European Union, United States for the following indications:

Approved in European Union as Deep Brain Stimulation for:

• Parkinson's disease
• Essential tremor
• Dystonia
• Epilepsy
• Obsessive-compulsive disorder

Approved in United States as Deep Brain Stimulation for:

• Parkinson's disease
• Essential tremor
• Dystonia
• Epilepsy
• Obsessive-compulsive disorder

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) is an emerging and powerful treatment option for patients with drug-resistant epilepsy, particularly for those with extratemporal epilepsy.

DBS involves a minimally invasive surgical procedure to implant a pacemaker that electrically stimulates specific brain structures, similar to its established use in treating Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refractory epilepsy and deep brain stimulation. Pereira, EA., Green, AL., Stacey, RJ., et al.[2011]

In a study of 47 patients who underwent deep brain stimulation (DBS) surgery, 70.2% experienced no adverse effects, indicating a generally favorable safety profile for this treatment.

However, the study identified that 19.1% of patients had hardware-related complications, including infections and lead malposition, highlighting the need for careful monitoring and management of these risks post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical-Related and Hardware-Related Adverse Effects of Deep Brain Stimulation: A Retrospective Single-Center Analysis. Erdem, NS., Ozkaynak, SS., Cakin, H., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Deep brain stimulation (DBS) is a promising treatment for patients with medically refractory epilepsy who do not respond to medications or surgery, targeting areas like the anterior thalamic nucleus and hippocampus.

While DBS shows effectiveness in controlling seizures, there are potential side effects related to electrode implantation and stimulation, highlighting the need for careful patient selection and treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for refractory epilepsy. Tykocki, T., Mandat, T., Kornakiewicz, A., et al.[2021]

Deep brain stimulation (DBS) for drug-resistant epilepsy may work by desynchronizing neuronal activity or modulating brain circuits involved in epilepsy, but the exact mechanism is still unclear.

Currently, there is strong evidence (class I) supporting the use of DBS specifically targeting the anterior nucleus of the thalamus, while other targets require further research with larger randomized trials to confirm their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in drug-resistant epilepsy]. Torres, CV., Iza-Vallejo, B., Navas-García, M., et al.[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]

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 (DBS) shows promising results in reducing seizure frequency for various types of epilepsy, particularly with the anterior nucleus of the thalamus (ANT) and responsive neurostimulation (RNS), which have been tested in larger patient groups and achieved strong evidence for efficacy and safety.

While all stimulation targets (ANT, hippocampus formation, and centromedian nucleus of the thalamus) showed encouraging results, ANT stimulation is effective for multifocal seizures, and hippocampus stimulation can help with temporal lobe epilepsy, indicating that different targets may be better suited for specific epileptic syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for intractabile epilepsy. Morace, R., DI Gennaro, G., Quarato, P., et al.[2022]

Deep brain stimulation (DBS) has shown promising results in treating epilepsy by targeting different brain regions, but there is still uncertainty about which specific seizure types respond best to which stimulation targets and parameters.

The review highlights the need for further research to identify clinical and anatomical features that could predict successful outcomes after DBS surgery for epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for the treatment of epilepsy. Hamani, C., Andrade, D., Hodaie, M., et al.[2009]

Deep brain stimulation (DBS) of the anterior nucleus of the thalamus (ANT) has been shown to be effective in reducing seizure frequency in adults with epilepsy that does not respond to multiple medications, based on a randomized trial involving this treatment.

The U.S. Food and Drug Administration has approved DBS therapy for epilepsy as an adjunctive treatment, specifically for patients aged 18 and older with partial onset seizures that are resistant to three or more antiepileptic drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for epilepsy. Salanova, V.[2019]

Deep brain stimulation (DBS) for Parkinson's disease is generally safe, with a low mortality rate of 0.2% and permanent morbidity at 0.6%, but complications such as intracerebral hemorrhage (ICH) and seizures can occur in a small percentage of cases.

The study found that the type of lead used in DBS can influence complications, with Medtronic's leads associated with higher rates of perielectrode brain edema compared to Boston Scientific's, highlighting the need for further research on hardware design to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. Servello, D., Galbiati, TF., Iess, G., et al.[2023]

Citations

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

Effect of deep brain stimulation on the severity of seizures ... Two-year follow-up data showed a median seizure frequency reduction of 56 % and a response rate (patients exhibiting more significant than 50 % ...

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

Deep brain stimulation for epilepsy: A systematic review ... Results. Fourty-nine articles met the inclusion criteria. The mean seizure reduction (SR) across 21 studies was 62.31 % (95 % CI: 55.99 ...

3. 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​​ DBS for Epilepsy was shown to reduce median seizure frequency, and these results improved over time. Our therapy benefits were consistent ...

4. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1169105/full

Deep brain stimulation for patients with refractory epilepsy Results: Out of the 65 included patients, 46 (70.8%) responded to DBS. Among the 65 patients, 45 underwent ANT-DBS, 29 (64.4%) responded to the treatment, and ...

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

The Evolving Landscape of DBS in Epilepsy - PMC The study reported a median seizure reduction of over 60% at 5 years, whereas the MORE study, demonstrated a median seizure reduction of 56% ...

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

P960009/S478 Summary of Safety and Effectiveness (SSED) Medtronic's Deep Brain Stimulator (DBS) System was approved for the following indications for use: • P960009 approved on July 31, 1997: Unilateral thalamic ...

7. aesnet.org aesnet.org/abstractslisting/single-center-retrospective-analysis-of-epilepsy-surgery-outcomes-from-deep-brain-stimulation-therapy-for-epilepsy

Single-Center-Retrospective-Analysis-of-Epilepsy-Surgery ... Results: The average seizure reduction was 65.83% at one year. If we exclude the patient who received concurrent surgeries of DBS and laser ...