tDCS for Focal Epilepsy
Recruiting in Palo Alto (17 mi)
+32 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Neuroelectrics Corporation
Must be taking: Antiepileptic drugs
Disqualifiers: Generalized seizures, Status epilepticus, others
No Placebo Group
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.
Will I have to stop taking my current medications?
The trial does not specify that you need to stop taking your current medications. However, you must be on at least one antiepileptic drug (AED) without any dose changes in the 3 weeks before starting the trial, and there should be no planned dose changes during the trial unless necessary for your health.
What data supports the effectiveness of the treatment tDCS for focal epilepsy?
Research shows that transcranial direct current stimulation (tDCS) can reduce seizure frequency and spikes in patients with focal epilepsy, including those with drug-resistant forms. Studies have demonstrated its potential benefits in both clinical and critical care settings, suggesting it may help manage seizures.12345
Is transcranial direct current stimulation (tDCS) safe for humans?
Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with no serious adverse effects reported in over 33,200 sessions and 1,000 subjects, including vulnerable populations. Common mild side effects include itching, tingling, and headaches, which are usually temporary.16789
How is tDCS treatment different from other treatments for focal epilepsy?
tDCS (Transcranial Direct Current Stimulation) is unique because it is a noninvasive treatment that uses a small electrical current applied to the scalp to reduce seizures, unlike traditional medications that are taken orally or injected. It works by modulating brain activity directly at the site of the seizure focus, offering a novel approach for patients with drug-resistant focal epilepsy.123510
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'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.
See 9 more
Exclusion Criteria
Nursing mothers.
My seizures originate from specific areas in my brain.
Pregnant or unwilling to practice birth control during participation in the study.
See 12 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
12 weeks
Treatment
Participants receive daily sessions with the STARSTIM device or sham for 10 sessions over a 2-week period
2 weeks
10 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including seizure rate, adverse events, and quality of life
10 weeks
3 visits (in-person)
Treatment Details
Interventions
- tDCS (Procedure)
Trial OverviewThe 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.
Participant Groups
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
More Trial Locations
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Who Is Running the Clinical Trial?
Neuroelectrics CorporationLead Sponsor
References
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.
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.
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.
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.
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.
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.
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.
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.
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.