tDCS: In Vivo Imaging of Therapeutic Electric Current Flow

Sponsor

University of Florida (Other)

Overall Status

Completed

CT.gov ID

NCT02453763

Collaborator

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

Enrollment

Location

25.2

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Epilepsy Alzheimer's Disease Stroke Autism Depression Schizophrenia	Device: Transcranial direct current stimulation Procedure: MRI

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 Design

Study Type:

Observational

Actual Enrollment :

17 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

In Vivo Imaging of Therapeutic Electric Current Flow

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Jul 6, 2017

Actual Study Completion Date :

Jul 6, 2017

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Magnetic Resonance Imaging (MRI) of therapeutic current flow [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.