TDCS for Epilepsy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Cognitive impairment, Intracranial pathology, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcranial direct current stimulation (tDCS) affects electrical activity in the brain, using measurements from individuals with electrodes placed for epilepsy surgery. The goal is to refine mathematical models to target tDCS more precisely in the future. The study is safe and focuses on data collection without altering brain function. Suitable participants are those undergoing electrode placement to determine the focus of their epilepsy. As an unphased study, this trial provides a unique opportunity to contribute to scientific understanding without changing brain function.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for epilepsy patients?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe and well-tolerated. Studies indicate it rarely causes serious side effects and is considered safe, particularly for treating epilepsy.

Some reports mention a small risk of seizures, but this is uncommon and can occur with any brain stimulation. Overall, tDCS is a non-invasive treatment, meaning it doesn't require surgery, and many patients handle it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for epilepsy, which often include medications like antiepileptic drugs (AEDs) or surgical interventions, Transcranial Direct Current Stimulation (TDCS) offers a non-invasive approach. Researchers are excited about TDCS because it uses mild electrical currents delivered through electrodes placed on the scalp to modulate brain activity. This method could potentially reduce seizure frequency and severity without the side effects associated with medications or the risks of surgery. Additionally, TDCS is a quick procedure, typically lasting no more than 30 minutes, making it a convenient option for patients.

What evidence suggests that tDCS is effective for epilepsy?

Studies have shown that transcranial direct current stimulation (tDCS), the treatment under investigation in this trial, can reduce seizures in people with epilepsy. One study found a 28% decrease in seizures after one month and a 49% decrease after two months of tDCS treatment. A review of multiple studies concluded that tDCS effectively reduces seizures in the short term and is generally well-tolerated by patients. Research also suggests that tDCS could be particularly beneficial for those with focal drug-resistant epilepsy, offering a non-invasive treatment option. Overall, these findings indicate that tDCS shows promise in managing epilepsy symptoms. ^{3 6 7 8 9}

Who Is on the Research Team?

Anli Liu, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent and speak English, undergoing evaluation for epilepsy surgery with intracranial electrodes already in place. It's not for those with cognitive impairment, skin issues on the face or forehead, MRI contraindications, adhesive allergies, certain brain pathologies, or recent seizures.

Inclusion Criteria

I have had electrodes placed in my brain to locate seizure sources or map critical brain areas.

Able to provide written informed consent

I am getting brain electrodes for epilepsy surgery evaluation.

Exclusion Criteria

I do not have skin issues on my face that would affect electrode placement.

I do not have any brain conditions or surgeries that could affect study results.

You had a seizure within one hour before the procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo transcranial direct current stimulation (tDCS) with electrodes applied at four extracranial sites for up to 30 minutes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI assessments

24 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation (TDCS)

Trial Overview

The study tests how electrical fields from Transcranial Direct Current Stimulation (TDCS) spread in the brain using measurements from patients' implanted electrodes. This data will help improve models to target TDCS therapy more effectively in future treatments.

How Is the Trial Designed?

Group I: Direct Cortical Measurement Experimental Treatment 1 Intervention

Consented subjects will also have transcranial electrodes applied at four extracranial sites, below the sterile dressing and distant from the surgical skull defect. The four electrodes will be placed in uniform positions based on the standard 10-10 electrode system, at the temples bilaterally (positions F9 and F10) and at the occiput bilaterally (positions PO9 and PO10). Subjects will be stimulated according to a predetermined set of parameters which fall well within empirically and computationally determined safety thresholds, as discussed above. The entire stimulation protocol is described in detail in section 5, and is anticipated to last no longer than 30 minutes.

Transcranial Direct Current Stimulation (TDCS) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Treatment-resistant depression
• Chronic pain
• Stroke rehabilitation
• Obesity management

Approved in European Union as Transcranial Direct Current Stimulation for:

• Treatment-resistant depression
• Chronic pain
• Stroke rehabilitation
• Neurological rehabilitation

Approved in Canada as Transcranial Direct Current Stimulation for:

• Treatment-resistant depression
• Chronic pain
• Stroke rehabilitation

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

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]

Transcranial direct current stimulation (tDCS) has shown preliminary safety and efficacy in reducing epileptic seizures in both animal studies and clinical trials involving 65 human participants, with 67% of studies reporting effective seizure reduction.

All patients tolerated tDCS well, indicating a favorable safety profile, but further research is needed to establish optimal stimulation protocols and assess long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation in Epilepsy. San-Juan, D., Morales-Quezada, L., Orozco Garduño, AJ., et al.[2018]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

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 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]

A systematic review of 158 studies involving 4130 participants found that repeated sessions of transcranial direct current stimulation (tDCS) do not significantly increase the risk of adverse events compared to sham treatments.

The study indicated that adverse event rates were consistent across different diagnostic groups, suggesting that tDCS is generally safe for various populations, although the potential for rare adverse events cannot be completely excluded.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of repeated sessions of transcranial direct current stimulation: A systematic review. Nikolin, S., Huggins, C., Martin, D., et al.[2019]

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 of 12 patients with drug-resistant mesial temporal lobe epilepsy with hippocampal sclerosis, cathodal transcranial direct current stimulation (tDCS) significantly reduced seizure frequency from an average of 10.58 to 1.67 seizures per month (p=0.003).

Eighty-three percent of patients experienced more than a 50% reduction in seizures after tDCS, with 50% becoming seizure-free for one month, indicating that tDCS could be a promising additional treatment option for patients awaiting or rejecting surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcranial direct current stimulation on seizure frequency of patients with mesial temporal lobe epilepsy with hippocampal sclerosis. Tekturk, P., Erdogan, ET., Kurt, A., et al.[2019]

Citations

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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 ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39588230/

Transcranial direct current stimulation in the management ...

The current meta-analysis on available trials indicates that tDCS can effectively reduce seizure frequency in the short term and is well-tolerated.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0920121124001712

A meta-analysis of RCTs and non-RCTs

tDCS significantly reduced seizures at 4 weeks and 8 weeks , with improvements in epileptiform discharges. •. Mechanisms, influencing factors, and advances like ...

4.

academic.oup.com

academic.oup.com/braincomms/article/7/1/fcaf012/8024004

Epileptogenic zone characteristics determine effectiveness of ...

Transcranial direct current stimulation shows promise as a non-invasive therapeutic method for patients with focal drug-resistant epilepsy.

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.

pmc.ncbi.nlm.nih.gov

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

Safety of transcranial Direct Current Stimulation: Evidence ...

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.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0965229925000172

The safety and effectiveness of tDCS for epileptic patients

Transcranial direct current stimulation (tDCS), an emerging non-invasive neural regulation technique, has a high safety profile and is an option for patients ...

8.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2024.1462364/full

Transcranial direct current stimulation in the management ...

The current meta-analysis on available trials indicates that tDCS can effectively reduce seizure frequency in the short term and is well-tolerated.

9.

e-bnr.org

e-bnr.org/DOIx.php?id=10.12786/bn.2021.14.e9

Safety of Transcranial Direct Current Stimulation in ...

A potential severe adverse effect of tDCS is seizure, which can be caused by any procedure that stimulates the central nervous system. Therefore ...