tDCS for Focal Epilepsy

Recruiting at 35 trial locations

Overseen By Susan Herman, M.D

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Neuroelectrics Corporation

Must be taking: Antiepileptic drugs

Disqualifiers: Generalized seizures, Status epilepticus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 13

Duration: 2 weeks

190 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a device called STARSTIM, which uses transcranial direct current stimulation (tDCS), to determine if it can safely reduce seizures in people with focal epilepsy. Participants will receive either actual treatment with the STARSTIM device or a placebo (sham) treatment over ten sessions in two weeks. The trial seeks individuals with epilepsy characterized by focal seizures not controlled by at least two anti-seizure medications and who experience three or more seizures per month. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new treatment options for epilepsy.

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 prior data suggests that the STARSTIM device is safe for treating focal epilepsy?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people with epilepsy. Studies indicate that tDCS can help reduce seizure frequency and is well-tolerated by patients. Most studies have not reported any serious side effects with typical tDCS settings, such as treatments lasting up to 40 minutes, suggesting the technique is quite safe. Some minor side effects, like skin irritation at the device site, can occur but are uncommon. Overall, tDCS has demonstrated minimal negative effects, making it a promising option for treating focal epilepsy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using transcranial direct current stimulation (tDCS) for focal epilepsy because it offers a non-invasive way to potentially reduce seizures. Unlike traditional medications that work by altering brain chemistry, tDCS uses mild electrical currents to modulate brain activity directly. This approach could minimize side effects often associated with epilepsy drugs and provide a new option for those who don't respond well to existing treatments. The ease of use and potential for at-home application make tDCS an appealing alternative for long-term management of epilepsy.

What evidence suggests that the STARSTIM device is effective for focal epilepsy?

Research has shown that transcranial direct current stimulation (tDCS) can reduce seizures in people with focal epilepsy. In this trial, participants will receive either an active STARSTIM device treatment, which uses tDCS, or a sham treatment. One study found that seizures decreased by about 28% one month after tDCS treatment and by 49% two months after. Another study demonstrated that using tDCS for fourteen days reduced seizures in individuals with difficult-to-treat focal epilepsy. This treatment typically has few side effects, offering a promising option for those who haven't found relief with medication alone. ^{1 3 4 6 7}

Who Is on the Research Team?

Abou-Khalil Bassel, M.D

Principal Investigator

Vanderbilt University Medical Center

Abou-Khalil Bassel, M.D

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• tDCS

Trial Overview 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.

How Is the Trial Designed?

Group I: STARSTIM device treatment Experimental Treatment 1 Intervention

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

Group II: Sham treatment Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Neuroelectrics Corporation

Lead Sponsor

Trials

8

Recruited

430+

Published Research Related to This Trial

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Transcranial direct current stimulation (tDCS) significantly reduced seizure frequencies in patients with refractory focal epilepsy, with a notable effect lasting up to 5 weeks after treatment.

The study found that a protocol of 2 sessions of 20 minutes of tDCS per day was more effective than a single 20-minute session, leading to a greater reduction in seizure frequencies compared to a sham treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Yang, D., Wang, Q., Xu, C., et al.[2021]

A systematic review of 64 studies involving 2262 participants found that transcranial direct current stimulation (tDCS) has a low dropout rate (6% for active and 7.2% for sham), indicating good acceptability among participants.

Despite the low dropout rates, many studies inadequately reported adverse events (AEs), highlighting a need for improved guidelines to standardize AE reporting in tDCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. Aparício, LVM., Guarienti, F., Razza, LB., et al.[2018]

Cathodal transcranial direct current stimulation (tDCS) at 100 microA for 60 minutes significantly increased the threshold for localized seizure activity in rats, lasting over 2 hours, indicating its potential as an anticonvulsant treatment.

Higher intensity cathodal tDCS at 200 microA for just 30 minutes also produced a similar lasting effect, while anodal tDCS did not show any significant impact, suggesting that the efficacy of tDCS in epilepsy may depend on the polarity and strength of the stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticonvulsant effects of transcranial direct-current stimulation (tDCS) in the rat cortical ramp model of focal epilepsy. Liebetanz, D., Klinker, F., Hering, D., et al.[2022]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial direct current stimulation (tDCS) is generally considered safe, with mild and transient adverse effects reported in clinical trials, but the frequency and relationship of these effects with clinical variables remain unclear due to selective reporting bias.

Out of 209 studies reviewed, 117 mentioned adverse effects, with common issues like itching and tingling reported more frequently in the active tDCS group, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Brunoni, AR., Amadera, J., Berbel, B., et al.[2022]

In a study involving 10 adult patients with refractory lateral frontal lobe epilepsy, high definition transcranial direct current stimulation (HD-tDCS) was well-tolerated with no adverse reactions reported, indicating its safety for use in this population.

While HD-tDCS did not significantly reduce epileptiform discharges or seizure frequency, it led to notable improvements in attention and working memory in all patients, suggesting potential cognitive benefits despite the lack of significant anticonvulsant effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HD-tDCS in refractory lateral frontal lobe epilepsy patients. Karvigh, SA., Motamedi, M., Arzani, M., et al.[2017]

Transcranial direct current stimulation (tDCS) applied at 2 mA over the seizure focus in four patients with focal status epilepticus led to significant reductions in interictal spikes and electrographic seizures, demonstrating its potential efficacy in critical care settings.

The treatment was well-tolerated with only minor side effects, and it allowed for reductions in antiseizure medications, suggesting a promising role for tDCS in managing refractory seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation for focal status epilepticus or lateralized periodic discharges in four patients in a critical care setting. Fisher, RS., McGinn, RJ., Von Stein, EL., et al.[2023]

Transcranial direct current stimulation (tDCS) significantly reduced interictal spike counts in rats with chronic seizures immediately after treatment, suggesting its potential efficacy in modulating epileptic activity.

The study found that enhanced delta oscillations during tDCS may underlie its inhibitory effects on seizure excitability, while changes in BDNF protein expression indicate a complex interaction between tDCS and neural mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delta oscillation underlies the interictal spike changes after repeated transcranial direct current stimulation in a rat model of chronic seizures. Wu, YJ., Chien, ME., Chiang, CC., et al.[2022]

Spaced transcranial direct current stimulation (tDCS) significantly reduced interictal epileptiform discharges (IEDs) by up to 68% and decreased seizure frequency in 15 adults with drug-resistant focal epilepsy, indicating its efficacy as a treatment option.

The treatment was well tolerated with no severe adverse events reported, suggesting that tDCS is a safe intervention for patients with unifocal epilepsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of spaced cathodal transcranial direct current stimulation in drug resistant focal epilepsies. Kaufmann, E., Hordt, M., Lauseker, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11586187/

Transcranial direct current stimulation in the management ... Our results indicated that tDCS reduced seizure frequency by ~28 and 49% within 1- and 2-month follow-ups post-treatment, respectively. Further ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04770337

Study Details | NCT04770337 | Pivotal-Safety and ... The purpose of this study is to evaluate efficacy, safety, and tolerability of repeated, daily sessions with the STARSTIM device, which delivers transcranial ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X19303699

Transcranial direct current stimulation reduces seizure ... Fourteen consecutive days tDCS significantly decreased SFs in patients with refractory focal epilepsy, with 2 × 20-min daily stimulation protocol being superior ...

4. karger.com karger.com/ene/article/88/1/18/918769/Effectiveness-of-Transcranial-Direct-Current

Effectiveness of Transcranial Direct Current Stimulation in ... Conclusion: tDCS reduces seizure frequency in patients with drug-resistant focal epilepsy and is associated with minimal adverse effects.

5. neurology.org neurology.org/doi/10.1212/WNL.0000000000206380

A Systematic Review and Meta-analysis (P3-1.011) It was found that tDCS significantly reduced SF and the number of IED. However, there was a heterogeneity in the SF at eight weeks of follow-up.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0965229925000172

The safety and effectiveness of tDCS for epileptic patients tDCS can reduce SF but has no effect on epileptiform discharges in patients with epilepsy. The current evidence is limited to support tDCS treatment for ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ... To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or ...