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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary study objective is to measure the electrical fields evoked by tDCS using subjects who have implanted intracranial electrodes as part of their evaluation for epilepsy surgery. The measurements obtained in these subjects and their brain MRI will be employed to validate existing mathematical models. In the future, these refined models can be used to target tDCS to predetermined brain regions in healthy and subjects and patient populations. As described above in the safety section, the intensities of stimulation applied in this project are not expected to produce changes in brain function, are below intensities commonly applied in clinical trials, and fall well below safety limits suggested by animal studies.

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 data supports the effectiveness of the treatment Transcranial Direct Current Stimulation (tDCS) for epilepsy?

Research shows that tDCS, a non-invasive treatment, can reduce seizure activity and abnormal brain signals in some epilepsy patients, including those with drug-resistant forms. Studies have demonstrated its potential benefits in both human and animal models, although results can vary. ^{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 or lasting side effects reported in over 33,200 sessions across various studies, including those involving potentially vulnerable groups like children and the elderly. However, some studies suggest that it could potentially cause significant issues, so caution is advised. ^{2 6 7 8 9}

How is the treatment TDCS for epilepsy different from other treatments?

Transcranial Direct Current Stimulation (tDCS) is unique because it is a non-invasive treatment that uses a small electrical current applied to the scalp to help reduce seizures, unlike traditional medications that are taken orally or injected. It is particularly considered for patients with drug-resistant epilepsy, offering a potential alternative when other treatments are ineffective. ^{1 2 3 4 5}

Research Team

Anli Liu, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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) 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]

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]

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]

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) 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, 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]

References

1. 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]

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

Transcranial Direct Current Stimulation in Epilepsy. [2018]

3. 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]

4. Netherlands 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. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) in the management of epilepsy: A systematic review. [2021]

6. 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]

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

Safety of repeated sessions of transcranial direct current stimulation: A systematic review. [2019]

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

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

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

Safety of transcranial direct current stimulation in healthy participants. [2021]