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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
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 belowSelect...
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:Select...
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
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.
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.
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
2 Trials studying Epilepsy
80 Patients Enrolled for Epilepsy
Abou-Khalil BasselPrincipal InvestigatorVanderbilt University Medical Center
Abou-Khalil Bassel, M.DPrincipal InvestigatorVanderbilt University Medical Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My seizures originate from specific areas in my brain.I've had a detailed brain MRI in the last 3 years, after any major skull surgery.I have had 3 or more seizures each month for the last year.My seizures have a specific area in my brain that can be targeted.You have metal implants in your head, except for thin titanium skull plates and dental fillings, or certain medical devices like pacemakers, brain stimulators, and cochlear implants.I have more than one area in my brain where seizures start.I do not have damaged skin on my scalp that could affect tDCS treatment.I've had surgery on my skull that left a space big enough for a small cylinder.I am on one or more seizure medications with no changes in the last 3 weeks and no planned changes during the trial.You have a history of seizures and have records to prove it.I am of childbearing age and will use highly effective birth control.I have been diagnosed with epilepsy that causes focal seizures.My epilepsy hasn't improved despite trying at least two different medications.My seizures have a specific area in my brain that can be targeted.I am 9 years old or older.I experience seizures that affect both sides of my brain.I have not had a continuous seizure lasting more than 5 minutes in the past year.My seizures are not localized to one specific area of my brain.I have had non-epileptic seizures that are different from my epileptic seizures, confirmed by video EEG.
Research Study Groups:
This trial has the following groups:- Group 1: Sham treatment
- Group 2: STARSTIM device treatment
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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