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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.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 12 post-treatment
Awards & highlights
Study Summary
This trial is testing a device that sends electrical current to the brain to treat depression. Subjects will use the device daily for 2 weeks and be followed for 10 weeks after to see if their depression improves.
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.Check my eligibility
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.See study design
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.
Select...
I have been diagnosed with epilepsy that causes focal seizures.
Select...
My seizures have a specific area in my brain that can be targeted.
Select...
I am 9 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to week 12 post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 12 post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Placebos
Secondary outcome measures
Seizures
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.
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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
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for prospective participants in this experiment?
"According to the clinicaltrials.gov database, this research is currently recruiting patients; it was submitted on October 25th 2021 and updated lastly on October 26th 2022."
Answered by AI
How many participants are currently being recruited for this scientific investigation?
"Yes, the online data indicates that this study is presently open for recruitment. It was posted on October 25th 2021 and last edited a year later. At present, 190 patients are needed across 14 different sites."
Answered by AI
In what geographical regions is the research taking place?
"This medical trial has 14 running sites, such as Seattle Children's Hospital and University of Washington in Seattle. Other listed locations include LifeBridge Health in Baltimore, Robert Wood Johnson Medical School (Rutgers) in New Brunswick, and 10 additional hospitals."
Answered by AI
Who else is applying?
What state do they live in?
Washington
What site did they apply to?
Seattle Children's Hospital, University of Washington
Southern Illinois University School of Medicine
Sinai Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Average response time
- < 1 Day
Typically responds via
Phone Call
Email
Most responsive sites:
- Seattle Children's Hospital, University of Washington: < 24 hours
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