What side effects are associated with this type of intervention?

Common treatments for epilepsy, particularly those involving intracranial EEG sensing and electrical brain stimulation, such as the Medtronic RC+S Summit, can have several side effects. These may include infection at the implantation site, bleeding, and discomfort or pain at the site of the device. Additionally, patients may experience headaches, mood changes, and cognitive effects such as memory issues. Broader treatments for epilepsy, including antiepileptic drugs, often have side effects like dizziness, fatigue, weight gain, and gastrointestinal issues. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for the treatment of epilepsy, which are similar to the Medtronic RC+S Summit trial. One notable example is the Vagus Nerve Stimulation (VNS) therapy, which involves an implanted device that sends electrical impulses to the vagus nerve to reduce seizure frequency. Another approved device is the Responsive Neurostimulation (RNS) System, which monitors brain activity and delivers electrical stimulation to prevent seizures before they start. These treatments represent significant advancements in epilepsy management, offering alternatives for patients who do not respond to traditional anti-seizure medications.

What other types of research exist?

Promising alternatives to the Medtronic RC+S Summit for epilepsy treatment include transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS). Both have shown potential in reducing symptoms in various neurological conditions and are being explored for their efficacy in epilepsy. Additionally, other forms of non-invasive electrical brain stimulation (EBS) are under investigation and may offer viable options in the near future.

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Neurostimulation Device

Brain Monitoring and Stimulation Device for Epilepsy

Phase 1

Waitlist Available

Led By Gregory A Worrell

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disabling seizure counts >3 per month (Disabling seizures are those with significant negative impact on the patient's life)

Age 18 to 75

Must not have

Subject is on anticoagulants and is unable to discontinue them peri-surgically, as required by the neurosurgeon or Investigator

Subject has had therapeutic surgery to treat epilepsy that may interfere with electrode placement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 15 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a brain implant and handheld device to monitor and prevent seizures in patients with specific types of epilepsy. The system detects seizures and uses electrical pulses to stop them, learning from the data it collects. There is now experimental and clinical evidence that direct electrical stimulation of the brain can prevent or decrease seizure activity.

Who is the study for?

Adults aged 18-75 with focal epilepsy, experiencing more than 3 disabling seizures per month despite stable medication use. Candidates should not be suitable for resective surgery and must be able to maintain a seizure diary and attend regular study visits. Women of childbearing potential must use reliable birth control.

What is being tested?

The trial is testing an implantable brain device (Medtronic RC+S Summit) paired with a handheld patient assistant device for tracking and potentially preventing seizures through electrical brain stimulation, using machine learning algorithms to predict seizure occurrence.

What are the potential side effects?

Potential side effects may include discomfort or complications from the surgical implant procedure, possible skin irritation from the device, adverse reactions to electrical brain stimulation such as changes in mood or cognition, and risks associated with long-term implantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I experience more than 3 severe seizures a month that disrupt my life.

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I am between 18 and 75 years old.

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I have focal epilepsy with various types of seizures.

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My body can accommodate the implantation of a Medtronic device close to my skin.

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My epilepsy originates from one or both sides of my brain's temporal lobes.

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I or my caregiver can clearly count and describe my seizure episodes.

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My seizures haven't improved with at least two different medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot stop taking my blood thinners for surgery as advised by my doctor.

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I had surgery for epilepsy that might affect where electrodes can be placed.

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I have been diagnosed with generalized seizures.

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I have been hospitalized for a mental health condition or had psychosis in the last two years.

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I have had a severe seizure without a clear cause in the last year.

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I cannot have surgery on my brain.

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I have been diagnosed with seizures not caused by epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24/7 continuous iEEG monitoring

Adverse events (AE) experienced with the RC+S system

Change in anxiety

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EpilepsyExperimental Treatment1 Intervention

Patients with dominant temporal lobe epilepsy and bilateral temporal lobe epilepsy

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Medtronic RC+S Summit trial involves intracranial EEG sensing and electrical brain stimulation, which are advanced treatments for epilepsy. Intracranial EEG sensing monitors brain activity to detect abnormal electrical patterns that precede seizures. Electrical brain stimulation then delivers targeted electrical impulses to disrupt these patterns and prevent seizures. This approach is significant for epilepsy patients as it offers real-time, personalized intervention, potentially reducing seizure frequency and improving quality of life. These treatments are particularly beneficial for patients with refractory epilepsy who do not respond to conventional medications.