Stimulating Probes and Electrodes for Epilepsy

Overseen By Ron Ball

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Permanent electronic implant, chronic conditions, others

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

Compensation: Varies

Number of Visits: Unknown

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the brain responds to small electrical signals using new types of electrodes. It targets individuals with epilepsy that does not improve with medication and who are considering brain surgery to remove the seizure-causing brain area. The trial will measure brain reactions to these signals. For those with medication-resistant epilepsy considering surgery, this trial may be suitable. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance future epilepsy treatments.

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

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 these stimulating probes and electrodes are safe for epilepsy?

Research has shown that brain stimulation treatments for epilepsy can be safe. For example, one study found that a type of brain stimulation reduced seizures over nine years and was considered safe. The SANTE trial demonstrated that deep brain stimulation decreased seizures by about 40.4%. These treatments send electrical signals to the brain, and long-term data suggests they are generally well-tolerated. However, these findings are based on similar technologies, not the exact treatment under study. It is important to discuss any concerns with a doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about stimulating probes and electrodes for treating medication-intractable epilepsy because they offer a new way to directly target and modulate brain activity. Unlike standard treatments, which often involve medication like anti-seizure drugs to control symptoms, this approach uses electrical stimulation to potentially reduce or even prevent seizures directly at their source. This method could provide a viable option for patients who do not respond well to traditional medications, offering hope for improved management of epilepsy with fewer side effects.

What evidence suggests that these stimulating probes and electrodes are effective for epilepsy?

Research has shown that using special devices, such as stimulating probes and electrodes, can greatly reduce seizures in people whose epilepsy doesn't respond to medication. One study found that seizures decreased by 49% after 44 months, while another study showed a 75% reduction. Additionally, a combined analysis of several studies reported a 52% decrease in seizures after six months of using this method. These results suggest that sending electrical signals to the brain can help control epilepsy when medications aren't effective. Overall, this approach shows promise in reducing the number of seizures and improving patients' lives. ^{1 6 7 8 9}

Who Is on the Research Team?

Matthew Willsey, MD, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with epilepsy that doesn't respond to medication and who are candidates for brain surgery to target seizure focus. Participants must be able to give informed consent. Those with chronic conditions preventing safe electrode placement or with permanent electronic implants cannot join.

Inclusion Criteria

I am willing and able to give my consent to participate in the study.

I have epilepsy that doesn't respond to medication and am recommended for surgery to remove the seizure focus.

Exclusion Criteria

Any chronic medical conditions that prevent safe placement of electrodes

Presence of a permanent electronic implant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Research Phase

Researchers measure brain responses using recording electrodes during a clinically indicated surgery

20 minutes

Follow-up

Participants are monitored for safety and effectiveness after the research phase

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stimulating Probes and Electrodes

Trial Overview Researchers are testing how the brain reacts to small electrical signals using a new combination of stimulating probes and recording electrodes. They aim to measure the brain's response in participants undergoing evaluation for epilepsy surgery.

How Is the Trial Designed?

Group I: Medication-intractable epilepsy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6563690/

Deep Brain Stimulation and Drug-Resistant Epilepsy A 49% reduction of seizure frequency was reported in four patients after 44 months of follow-up (58). Similarly, a mean reduction of 75% was observed in four ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07014592?draw=2&rank=1

NCT07014592 | Characterization and Analysis of Evoked ... Characterization and Analysis of Evoked Cortical Responses in Participants With Medication-intractable Epilepsy ... Device : stimulating probes and electrodes.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0303846725002756

Review article Deep brain stimulation for refractory epilepsy This meta-analysis underscores the importance of tailored DBS parameters to improve outcomes in patients with drug-resistant epilepsy, highlighting DBS as a ...

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

Long-term efficacy and safety of thalamic stimulation for ... The median percent seizure reduction from baseline at 1 year was 41%, and 69% at 5 years. The responder rate (≥50% reduction in seizure frequency) at 1 year was ...

5. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2802793

Focal Cortex Stimulation With a Novel Implantable Device ... A pooled analysis showed a 52% reduction in seizure frequency and at least a 50% response in the sixth month of neurostimulation compared with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12185915/

Deep Brain Stimulation Therapy for Drug-Resistant Epilepsy The seminal SANTE trial provided robust evidence of its efficacy, with an initial median seizure reduction of approximately 40.4% observed ...

7. 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.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0965229925000172

The safety and effectiveness of tDCS for epileptic patients The current evidence is limited to support tDCS treatment for depression, anxiety, and cognitive function in epilepsy patients.

9. practicalneurology.com practicalneurology.com/diseases-diagnoses/epilepsy-seizures/neuromodulation-and-epilepsy/30179/

Neuromodulation for Epilepsy - - Practical Neurology In ongoing follow up over 8 years, 66% of patients enrolled in the trial achieved >50% seizure reduction at year 8, 30% had >90% seizure reduction over the most ...