tDCS for Focal Epilepsy

Recruiting at32 trial locations

Overseen by Abou-Khalil Bassel, M.D

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 2 3 5 10}

Research Team

Abou-Khalil Bassel, M.D

Principal Investigator

Vanderbilt University Medical Center

Abou-Khalil Bassel, M.D

Principal Investigator

Vanderbilt University Medical Center

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.

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.

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 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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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) 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Acute effects of spaced cathodal transcranial direct current stimulation in drug resistant focal epilepsies. [2021]

2. United States 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. [2021]

3. United States 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

HD-tDCS in refractory lateral frontal lobe epilepsy patients. [2017]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

8. England pubmed.ncbi.nlm.nih.gov

A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Anticonvulsant effects of transcranial direct-current stimulation (tDCS) in the rat cortical ramp model of focal epilepsy. [2022]