Brain Stimulation for Epilepsy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Unable to provide informed consent

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the involvement of certain brain areas, specifically parts of the thalamus, in epilepsy and memory. Researchers seek to understand how seizures affect these areas and how stimulating them might impact memory formation. Participants will undergo cognitive tests and receive gentle electrical brain stimulation. This trial suits epilepsy patients who already have electrodes implanted in their brains and can understand and consent to the study.

As an unphased study, this trial offers a unique opportunity for patients to contribute to groundbreaking research that could enhance understanding and treatment of epilepsy-related memory issues.

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 is safe for epilepsy patients?

Research has shown that electrical stimulation of the brain is usually safe and well-tolerated. For instance, studies have found that deep brain stimulation, a type of electrical treatment, reduces seizures in people with epilepsy. These studies demonstrate long-term benefits and acceptable safety for those whose epilepsy does not respond to medication.

One study on brain-responsive neurostimulation reported a significant decrease in focal seizures over nine years, with manageable safety concerns. This indicates the treatment did not cause any unexpected or severe side effects.

Additionally, using electrical stimulation during sEEG, a type of brain monitoring, is considered safe and well-tolerated in children, suggesting it is likely safe for adults as well.

Overall, while safety can vary depending on the specific type of electrical stimulation, current research supports its general safety in humans, especially for those with epilepsy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the brain stimulation techniques being explored for epilepsy because they offer a unique approach compared to traditional treatments like anti-seizure medications and surgery. Unlike most treatments that aim to control symptoms chemically or through invasive procedures, electrical stimulation of the brain targets the thalamus directly with the potential to modulate neural activity and prevent seizures before they start. This method could offer more precise control over seizures and reduce side effects associated with long-term medication use. Additionally, the integration of cognitive experiments alongside electrical stimulation may provide insights into how brain function relates to seizure control, paving the way for personalized treatment strategies.

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

Research has shown that electrical stimulation of the brain can greatly reduce seizures in people with epilepsy. Participants in this trial will undergo cognitive testing and electrical stimulation experiments. One study found that stimulating the thalamus reduced seizure frequency by more than half in 90% of patients. Another study reported an average seizure reduction of 93%, with some patients achieving full control. Many patients also report significant improvements in their quality of life. These findings suggest that electrical stimulation is a promising method for managing epilepsy symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Josef Parvizi, MD PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with epilepsy. Participants should be able to undergo cognitive experiments and electrical stimulation of the brain. Specific details about inclusion and exclusion criteria are not provided, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I have no health issues preventing me from getting an electrode implant.

I understand the study details and can sign the consent form myself.

Exclusion Criteria

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experiment

Participants undergo cognitive testing and electrical stimulation experiments to map thalamocortical and corticothalamic connectivity and assess memory formation

2 weeks

5 sessions

Follow-up

Participants are monitored for safety and effectiveness after the experiment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive experiment
• Electrical stimulation of the brain

Trial Overview The study investigates how two parts of the thalamus (ANT and PLV) interact with other brain areas during seizures and memory processes. It involves mapping these interactions (Aim 1), understanding seizure propagation in these regions (Aim 2), and studying how stimulating them affects memory formation (Aim 3).

How Is the Trial Designed?

Group I: Epilepsy Patients with Thalamic Electrode Implants Experimental Treatment 2 Interventions

Patients will undergo cognitive testing and electrical stimulation experiments.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9133258/

Brain stimulation treatments in epilepsy: Basic mechanisms ... In addition to the seizure reduction, patients reported an overall improvement in their quality of life, with 43% reporting a 5-point or more improvement on the ...

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

Deep brain stimulation for epilepsy: A systematic review ... Our findings demonstrate high responder rates and reductions in seizure frequency for DBS targeting the ANT or CMN of the thalamus with low rates of seizure ...

3. nature.com nature.com/articles/s41467-025-64922-w

Thalamocortical hodology to personalize electrical ... Indeed, in a recent clinical trial, Cukiert and colleagues reported a significant seizure reduction (> 50%) with CM electrical stimulation in 90 ...

4. academic.oup.com academic.oup.com/braincomms/advance-article/8196834

Thalamocortical network neuromodulation for epilepsy Seven patients with a median age at implant of 22 years (range 14–42 years) had a median disabling seizure reduction of 93% (range 50–100%, P = 0.0156), with ...

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000001334

Long-term efficacy and safety of thalamic stimulation for ... Several clinical markers improved in addition to seizure frequency. Five years after implantation, nearly half of the subjects experienced a clinically ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24228081/

Electrical stimulation for drug-resistant epilepsy The studies of DBS and VNS in adults found significantly improved rates of seizure frequency, but the study of VNS in children did not find a ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1525505025002586

Review Seizure outcomes after cortical stimulation-induced ... High frequency stimulation is more likely to elicit seizures. •. Low frequency stimulation induced seizures may be more predictive of surgical outcomes.

8. neurology.org neurology.org/doi/10.1212/WNL.0000000000010154

Nine-year prospective efficacy and safety of brain- ... This study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years. About 30% ...

9. medrxiv.org medrxiv.org/content/10.1101/2025.06.17.25329709v1.full-text

Electrical Stimulation for the Induction of Seizures is Safe ... Significance Comprehensive seizure stimulation during sEEG is safe, well-tolerated, and high-yield in children. Both 1 Hz and 50 Hz stimulation ...

10. 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 The study's outcomes demonstrated the safety, effectiveness and long-term benefits of Deep Brain Stimulation therapy for medically refractory partial-onset ( ...