TDCS for Epilepsy

Recruiting in Palo Alto (17 mi)

Overseen byAnli Liu, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Approved in 3 Jurisdictions

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.

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.

I am 18 years old or older.

I speak English.

+2 more

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.

+3 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Direct Cortical MeasurementExperimental Treatment1 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: