In Vivo Imaging of Therapeutic Electric Current Flow (tDCS)

April 4, 2018 updated by: University of Florida
The purpose of this research study is to measure current flow inside the head using magnetic resonance imaging (MRI). The data from this study will be used to map the current flow caused from the electrical stimulation inside the head. The methods develop will be used to map and better control delivery of the current for electrical stimulation to modify a psychiatric condition such as depression; or other conditions such as epilepsy, Parkinson's disease or autism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transcranial direct current stimulation (tDCS) and deep brain stimulation (DBS) are examples of electrical stimulation therapies that are rapidly gaining attention as means of modulating motor function, semantic processing, and executive function. Both therapies have attracted many clinical and experimental studies. tDCS has been found to have both facilitatory and inhibitory effects on the brain depending on stimulation polarity and electrode position. DBS has been thoroughly evaluated clinically for treatment of movement disorders, principally Parkinson's disease, and is extending its reach to include treatment of disorders such as focal dystonia, depression and chronic pain. While still mostly in the experimental stage, tDCS applications and acceptance are growing extremely rapidly.

Although the functional alterations associated with tDCS can be categorized without knowledge of the underlying neurophysiology, an understanding of where externally applied current actually flows in any electrical stimulation technique is crucial as a basis for understanding which brain regions, circuits, or elements are affected by these therapies, and how these changes may occur. Such knowledge will lead to a better understanding of the mechanisms underlying these therapies, and thus to more focused and effective stimulation patterns and locations. Ultimately, this will lead to more efficient and novel clinical applications.

Many studies have simulated the effects of current application in both extra- and intracranial modalities using computer simulation. Simulations will always be limited by errors in interpreting MRI data during segmentation, differences between assumed and actual electrical conductivity values, and mismatches between actual and presumed electrode locations and sizes. Thus, better methods to understand and verify current flow distributions are badly needed.

In this study a recently developed MRI-based phase imaging technique to more directly measure current densities in vivo. Unlike earlier MRI-based methods of measuring electrical current flow, the technique works without requiring subject repositioning. This methods will be validated against high-resolution subject-specific models incorporating many tissue compartments, including anisotropic white matter. Thus, a new direct measurement method against state-of-the-art modeling approaches.

Study Type

Observational

Enrollment (Actual)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

24 normal adult subjects will be assessed.

Description

Inclusion Criteria:

  • right handed (as determined by the Edinburgh battery),
  • English as native language.

Exclusion Criteria:

  • appreciable deficits in hearing,
  • appreciable problems with articulation,
  • appreciable accent schizophrenia, bipolar disorder, or major depression,
  • any neurological disorder associated with cognitive impairment or neuroanatomic abnormality,
  • language-based learning disorder,
  • any implanted metal device (precludes use of tDCS), any implanted cardiac pacemaker,
  • dementia or mini-mental state exam,
  • <24 estimated verbal intelligence,
  • <70 active or prior history of seizure disorder, family history of seizure disorder, prescribed seizure inducing medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transcranial direct current stimulation
All participants will receive transcranial direct current stimulation and an magnetic resonance imaging (MRI).
Device: Transcranial direct current stimulation
All participants will receive transcranial direct current stimulation. During the MRI images of the head a battery-powered device pulses a small current between a pair of the electrodes which will be immediately followed by more MRI images. The current pulses will be very short and there should be no feeling from the pulses. The entire imaging period will be at most 90 minutes.
Other Names:
  • Noninvasive Brain Stimulation
Procedure: MRI
All participants will receive an MRI. During the MRI images of the head a battery-powered device pulses a small current between a pair of the electrodes which will be immediately followed by more MRI images. The current pulses will be very short and there should be no feeling from the pulses. The entire imaging period will be at most 90 minutes.
Other Names:
  • Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Magnetic Resonance Imaging (MRI) of therapeutic current flow
Time Frame: Day 1
The MRI will be used to measure current flow in the brain as a result of therapeutic electrical stimulation techniques by using a recently developed MRI-based phase imaging technique to more directly measure current densities in vivo.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
Arizona State University

Investigators

  • Principal Investigator: Thomas H Mareci, Ph.D., University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

July 6, 2017

Study Completion (Actual)

July 6, 2017

Study Registration Dates

First Submitted

May 21, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 25, 2015

Study Record Updates

Last Update Posted (Actual)

April 5, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 506-2012-N
  • 1R21NS081646-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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