What side effects are associated with this type of intervention?

The most common side effects of transcranial cathodal direct current stimulation (tDCS) for epilepsy include mild skin irritation or redness at the site of electrode placement, headache, dizziness, and a tingling sensation during the procedure. Similar noninvasive neuromodulation therapies like repetitive transcranial magnetic stimulation (rTMS) may also cause transient scalp discomfort, mild headaches, and, rarely, seizures. These side effects are generally mild and temporary, making these treatments relatively well-tolerated options for managing epilepsy.

What prior FDA approvals exist?

The FDA has approved various drugs for the treatment of epilepsy, including lamotrigine, valproate, carbamazepine, and levetiracetam, among others. These medications are used to manage different types of seizures and have shown efficacy in clinical trials. While transcranial cathodal direct current stimulation (tDCS) like the STARSTIM device is still under investigation and not yet FDA-approved for epilepsy, other neuromodulation techniques such as vagus nerve stimulation (VNS) and responsive neurostimulation (RNS) have received FDA approval for treatment-resistant epilepsy.

What other types of research exist?

Promising, novel alternatives to the STARSTIM device for epilepsy patients include: 1) Repetitive Transcranial Magnetic Stimulation (rTMS), which uses magnetic fields to stimulate specific brain areas and has shown efficacy in various neurological conditions. 2) Vagus Nerve Stimulation (VNS), an invasive procedure that involves stimulating the vagus nerve to reduce seizure frequency. 3) Deep Brain Stimulation (DBS), another invasive technique that targets specific brain regions to control seizures. These alternatives offer different mechanisms of action and may be considered based on individual patient needs and treatment responses.

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Procedure

tDCS for Focal Epilepsy

N/A

Recruiting

Led By Abou-Khalil Bassel

Research Sponsored by Neuroelectrics Corporation

Eligibility Criteria Checklist

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

Must have

Seizure frequency ≥3 per month, over the past year.

Diagnosis of epilepsy with focal seizures with or without focal to bilateral tonic clonic seizures (International League Against Epilepsy classification). Diagnosis established by both clinical history and an EEG consistent with focal seizures. (Note: A normal interictal EEG is consistent with focal seizures, if other data is adequate to provide localization.)

Must not have

Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal

Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial tests the STARSTIM device, which sends small electrical currents to the brain, on epilepsy patients over 9 years old who have focal seizures. The goal is to see if this device can help reduce their seizures. Patients will use the device regularly for a short period and be monitored for a few months afterward.

Who is the study for?

This trial is for people aged 9 or older with refractory focal epilepsy, meaning their seizures haven't been controlled despite trying at least two medications. They must have a recent MRI scan and not plan to change their seizure medication during the trial. Women of childbearing age must use effective birth control and not be pregnant or nursing.

What is being tested?

The study tests the STARSTIM device's safety and effectiveness in reducing seizures through daily sessions over two weeks, followed by ten weeks of observation. Participants are randomly assigned to receive either real tDCS treatment with STARSTIM or a sham (fake) device, without knowing which one they're getting.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site on the scalp, headache, fatigue, nausea, or itching under the electrode. Since it's non-invasive brain stimulation, risks are considered low but will be closely monitored.

Eligibility Criteria

Inclusion Criteria

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

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I have had 3 or more seizures each month for the last year.

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I have been diagnosed with epilepsy that causes focal seizures.

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My seizures have a specific area in my brain that can be targeted.

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I am 9 years old or older.

Exclusion Criteria

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

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My seizures originate from specific areas in my brain.

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I've had surgery on my skull that left a space big enough for a small cylinder.

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I experience seizures that affect both sides of my brain.

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I have not had a continuous seizure lasting more than 5 minutes in the past year.

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My seizures are not localized to one specific area of my brain.

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I have had non-epileptic seizures that are different from my epileptic seizures, confirmed by video EEG.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: STARSTIM device treatmentExperimental Treatment1 Intervention

Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.

Group II: Sham treatmentPlacebo Group1 Intervention

Subjects will be randomized in a 1:1 ratio to receive an active STARSTIM treatment or a sham treatment.

0 / 10Eligibility 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

Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that involves applying a low electrical current to the scalp to modulate neuronal activity. In epilepsy, cathodal tDCS is used to reduce cortical excitability at the seizure focus, potentially decreasing the frequency and severity of seizures. This method is particularly relevant for patients with drug-resistant epilepsy, offering a promising alternative when traditional pharmacotherapy fails. Other common treatments for epilepsy include antiepileptic drugs (AEDs), which work by stabilizing neuronal membranes and reducing excitability, and surgical interventions for refractory cases. Understanding these mechanisms is crucial for tailoring individualized treatment plans and improving patient outcomes.

Transcranial direct current stimulation (tDCS) in the management of epilepsy: A systematic review.

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Who is running the clinical trial?

Neuroelectrics CorporationLead Sponsor

7 Previous Clinical Trials

242 Total Patients Enrolled

Abou-Khalil BasselPrincipal InvestigatorVanderbilt University Medical Center

Abou-Khalil Bassel, M.DPrincipal InvestigatorVanderbilt University Medical Center

Media Library

tDCS (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04770337 — N/A

Focal Seizures Research Study Groups: Sham treatment, STARSTIM device treatment

Focal Seizures Clinical Trial 2023: tDCS Highlights & Side Effects. Trial Name: NCT04770337 — N/A

tDCS (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04770337 — N/A

~50 spots leftby Sep 2025

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