Direct Cortical Measurement of the Intensity and Pattern of Current Flow Produced by TDCS

NCT02263274 | Completed DMC

• 1 other identifier: 13-01171
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

• Current Intensity

  MRI

  24 hour Post Op

• Total charge (stimulation intensity x duration of stimulation in coulombs

  MRI

  24 Hour Post Op

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

  MRI

  24 Hour Post Op

Study Arms (1)

Direct Cortical Measurement

EXPERIMENTAL

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.

Device: Transcranial Direct Current Stimulation (TDCS)

Interventions

Transcranial Direct Current Stimulation (TDCS) DEVICE

Conventional tDCS and low-frequency tACS are commonly administered at a current intensity of 2 mA or less

Also known as: TDCS

Direct Cortical Measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Placement of intracranial electrode arrays (grid, strip and or depth electrodes) for seizure focus localization and/or mapping of eloquent cortex
• Able to provide written informed consent
• English-speaking patients only

You may not qualify if:

• Cognitive impairment (Intelligence Quotient \<70)
• Facial or forehead skin breakdown that would interfere with surface electrode placement
• Contraindication to MRI
• Known adhesive allergy
• 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.
• Subjects who have had an electrographic or clinical seizure within one hour prior to the stimulation procedure

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Neurology

New York, New York, 11106, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Anli Liu, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 13, 2014
• Study Start: November 1, 2013
• Primary Completion: January 9, 2026
• Study Completion: January 9, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)