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

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 trial coordinators or your doctor.

What data supports the effectiveness of the treatment Deep Brain Stimulation (DBS) for epilepsy?

Deep Brain Stimulation (DBS) has shown promising results in reducing seizures for people with epilepsy that doesn't respond to medication. Studies indicate that targeting specific brain areas, like the anterior nucleus of the thalamus, can help decrease seizure frequency and improve quality of life. ^{1 2 3 4 5}

Is deep brain stimulation (DBS) safe for humans?

Deep brain stimulation (DBS) has been studied for its safety in treating epilepsy and other conditions. The U.S. Food and Drug Administration has approved DBS for epilepsy, indicating it is generally considered safe, though there can be surgical and hardware-related side effects. ^{1 2 6 7 8}

How does the treatment Deep Brain Stimulation (DBS) for epilepsy differ from other treatments?

Deep Brain Stimulation (DBS) is unique because it involves implanting a device that sends electrical impulses to specific brain areas to control seizures, especially for patients who don't respond to medication or surgery. Unlike other treatments, DBS is minimally invasive and reversible, offering a new option for those with drug-resistant epilepsy. ^{1 2 9 10 11}

What is the purpose of this trial?

A primary purpose of this study is to better understand what stimulation parameters work best for patients. For example, for Deep Brain Stimulation (DBS) of the Anterior Nucleus of the Thalamus (ANT), it is not clear what stimulation frequency leads is most effective. This study will help assess the effectiveness of low frequency or high frequency stimulation.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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) 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]

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) 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]

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) 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]

References

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

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

2. Netherlands 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. [2022]

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

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

4. Italy pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for intractabile epilepsy. [2022]

5. Singapore pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for the treatment of epilepsy. [2009]

6. Turkey pubmed.ncbi.nlm.nih.gov

Surgical-Related and Hardware-Related Adverse Effects of Deep Brain Stimulation: A Retrospective Single-Center Analysis. [2022]

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

Deep brain stimulation for epilepsy. [2019]

8. Austria pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]

9. Poland pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for refractory epilepsy. [2021]

10. Spain pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in drug-resistant epilepsy]. [2021]

11. Scotland pubmed.ncbi.nlm.nih.gov

Refractory epilepsy and deep brain stimulation. [2011]