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Corticosteroid

TDCS for Epilepsy

N/A

Waitlist Available

Led By Anli Liu, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Placement of intracranial electrode arrays (grid, strip and or depth electrodes) for seizure focus localization and/or mapping of eloquent cortex

Age ≥ 18 years

Must not have

Facial or forehead skin breakdown that would interfere with surface electrode placement

Space occupying intracranial pathology including brain tumor, ateriovenous malformation, cavernous malformation, prior surgical resection or significant encephalomalcia that would create unknown tissue inhomogeneity that cannot be accurately modeled

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hour post op

Awards & highlights

No Placebo-Only Group

Summary

This trial is measuring the electrical fields caused by tDCS in people with implanted electrodes as part of their evaluation for epilepsy surgery, in order to improve mathematical models. The models can then be used to target tDCS to specific brain regions in healthy and sick people. The stimulations used in this trial are not expected to produce any changes in brain function.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While this study uses low-intensity stimulation that's unlikely to change brain function and is considered safe based on animal studies and clinical trials standards, potential side effects are not detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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I speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have been diagnosed with cognitive impairment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hour post op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hour post op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hour post op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Current Intensity

Total charge (stimulation intensity x duration of stimulation in coulombs

Total electrode charge density (total charge/electrode area in coloumbs/meters2) as measured at various subdural and depth electrode recording sites

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met