Trial Summary
What is the purpose of this trial?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.
Is tDCS a promising treatment for focal epilepsy?Yes, tDCS is a promising treatment for focal epilepsy. Studies show it can reduce seizure frequency and has been beneficial in both human and animal models. It is a noninvasive method that uses a small electrical current to help control seizures.167810
Do I need to stop my current medications for the trial?No, you don't need to stop your current medications. Participants must be on at least one antiepileptic drug (ASD) with no changes in doses 3 weeks before the trial and no planned changes during the trial, unless clinically necessary.
What safety data exists for tDCS treatment?The safety of transcranial direct current stimulation (tDCS) has been extensively reviewed. A 2016 evidence-based update found no reports of serious adverse effects or irreversible injury across over 33,200 sessions and 1,000 subjects, including vulnerable populations. Common mild and transient adverse effects include itching, tingling, headache, burning sensation, and discomfort, but these are not statistically significant compared to sham treatments. Systematic reviews suggest that tDCS is generally safe, though there is a need for improved reporting of adverse effects.23489
What data supports the idea that tDCS for Focal Epilepsy is an effective treatment?The available research shows that tDCS can be effective for treating focal epilepsy. One study found that tDCS reduced seizure frequency in patients with difficult-to-treat focal epilepsy. Another study demonstrated that tDCS could reduce spikes and seizures in patients with focal status epilepticus, a severe form of epilepsy. These findings suggest that tDCS can help manage seizures in people with focal epilepsy, especially when other treatments have not worked.567810
Eligibility Criteria
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.Inclusion Criteria
I have had 3 or more seizures each month for the last year.
I have been diagnosed with epilepsy that causes focal seizures.
My seizures have a specific area in my brain that can be targeted.
I am 9 years old or older.
Exclusion Criteria
My seizures originate from specific areas in my brain.
I've had surgery on my skull that left a space big enough for a small cylinder.
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.
Treatment Details
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.
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.
Find a clinic near you
Research locations nearbySelect from list below to view details:
LifeBridge HealthBaltimore, MD
UW Valley Medical CenterRenton, WA
Barrow Neurological Institute, St. Joseph's Hospital & Medical CenterPhoenix, AZ
University of Florida JacksonvilleJacksonville, FL
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Who is running the clinical trial?
Neuroelectrics CorporationLead Sponsor
References
Anticonvulsant effects of transcranial direct-current stimulation (tDCS) in the rat cortical ramp model of focal epilepsy. [2022]Weak direct currents induce lasting alterations of cortical excitability in animals and humans, which are controlled by polarity, duration of stimulation, and current strength applied. To evaluate its anticonvulsant potential, transcranial direct current stimulation (tDCS) was tested in a modified cortical ramp-stimulation model of focal epilepsy.
A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]Transcranial direct current stimulation (tDCS) is a non-invasive method of brain stimulation that has been intensively investigated in clinical and cognitive neuroscience. Although the general impression is that tDCS is a safe technique with mild and transient adverse effects (AEs), human data on safety and tolerability are largely provided from single-session studies in healthy volunteers. In addition the frequency of AEs and its relationship with clinical variables is unknown. With the aim of assessing tDCS safety in different conditions and study designs, we performed a systematic review and meta-analysis of tDCS clinical trials. We assessed Medline and other databases and reference lists from retrieved articles, searching for articles from 1998 (first trial with contemporary tDCS parameters) to August 2010. Animal studies, review articles and studies assessing other neuromodulatory techniques were excluded. According to our eligibility criteria, 209 studies (from 172 articles) were identified. One hundred and seventeen studies (56%) mentioned AEs in the report. Of these studies, 74 (63%) reported at least one AE and only eight studies quantified AEs systematically. In the subsample reporting AEs, the most common were, for active vs. sham tDCS group, itching (39.3% vs. 32.9%, p>0.05), tingling (22.2% vs. 18.3%, p>0.05), headache (14.8% vs. 16.2%, p>0.05), burning sensation (8.7% vs. 10%, p>0.05) and discomfort (10.4% vs. 13.4%, p>0.05). Meta-analytical techniques could be applied in only eight studies for itching, but no definite results could be obtained due to between-study heterogeneity and low number of studies. Our results suggested that some AEs such as itching and tingling were more frequent in the tDCS active group, although this was not statistically significant. Although results suggest that tDCS is associated with mild AEs only, we identified a selective reporting bias for reporting, assessing and publishing AEs of tDCS that hinders further conclusions. Based on our findings, we propose a revised adverse effects questionnaire to be applied in tDCS studies in order to improve systematic reporting of tDCS-related AEs.
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation investigated as a treatment for several neuropsychiatric disorders. Notwithstanding tDCS-induced adverse events (AEs) are considered to be low and transient, systematic review analyses on safety and tolerability of tDCS derive mostly from single-session studies.
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3-13 A/m(2)) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.
HD-tDCS in refractory lateral frontal lobe epilepsy patients. [2017]To evaluate the anticonvulsant effect of the novel high definition transcranial direct current stimulation (HD-tDCS) method on patients with refractory lateral frontal lobe epilepsy. The effects of HD-tDCS on working memory were also examined.
Transcranial direct current stimulation reduces seizure frequency in patients with refractory focal epilepsy: A randomized, double-blind, sham-controlled, and three-arm parallel multicenter study. [2021]Transcranial direct current stimulation (tDCS) has been explored in epilepsy with limited samples, varied parameters, and inconclusive results. We aimed to study the efficacy of tDCS for patients with refractory focal epilepsy.
Delta oscillation underlies the interictal spike changes after repeated transcranial direct current stimulation in a rat model of chronic seizures. [2022]Transcranial direct current stimulation (tDCS) provides a noninvasive polarity-specific constant current to treat epilepsy, through a mechanism possibly involving excitability modulation and neural oscillation.
Acute effects of spaced cathodal transcranial direct current stimulation in drug resistant focal epilepsies. [2021]To evaluate the safety and temporal dynamic of the antiepileptic effect of spaced transcranial direct current stimulation (tDCS) in different focal epilepsies.
Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]Transcranial direct current stimulation (tDCS) is reported to induce irritating skin sensations and occasional skin injuries, which limits the applied tDCS dose. Additionally, tDCS hardware safety profile prevents high current delivery when skin resistance is high.
Transcranial direct current stimulation for focal status epilepticus or lateralized periodic discharges in four patients in a critical care setting. [2023]Transcranial direct current stimulation (tDCS) has been advocated for various neurological conditions, including epilepsy. A 1-4-mA cathodal current applied to the scalp over a seizure focus can reduce spikes and seizures. This series of four patients with focal status epilepticus is among the first case series to demonstrate benefit of tDCS in the critical care setting.