In Vivo Imaging of Therapeutic Electric Current Flow

NCT ID: NCT02453763

Last Updated: 2018-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-07-06

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.

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.

Conditions

Parkinson Disease; Epilepsy; Alzheimer's Disease; Stroke; Autism; Depression; Schizophrenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Transcranial direct current stimulation

All participants will receive transcranial direct current stimulation and an magnetic resonance imaging (MRI).

Transcranial direct current stimulation

Intervention Type: DEVICE

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.

MRI

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Other Intervention Names

Noninvasive Brain Stimulation; Magnetic Resonance Imaging

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arizona State University

OTHER

Sponsor Role: collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas H Mareci, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Countries

United States

References

Sadleir RJ, Sajib SZ, Kim HJ, Kwon OI, Woo EJ. Simulations and phantom evaluations of magnetic resonance electrical impedance tomography (MREIT) for breast cancer detection. J Magn Reson. 2013 May;230:40-9. doi: 10.1016/j.jmr.2013.01.009. Epub 2013 Feb 4.

Reference Type: BACKGROUND

PMID: 23435264 (View on PubMed)

Meng ZJ, Sajib SZ, Chauhan M, Sadleir RJ, Kim HJ, Kwon OI, Woo EJ. Numerical simulations of MREIT conductivity imaging for brain tumor detection. Comput Math Methods Med. 2013;2013:704829. doi: 10.1155/2013/704829. Epub 2013 Apr 29.

Reference Type: BACKGROUND

PMID: 23737862 (View on PubMed)

DeMarse TB, Carney PR. Augmentation of cognitive function in epilepsy. Front Syst Neurosci. 2014 Aug 14;8:147. doi: 10.3389/fnsys.2014.00147. eCollection 2014. No abstract available.

Reference Type: BACKGROUND

PMID: 25177279 (View on PubMed)

Sadleir RJ, Vannorsdall TD, Schretlen DJ, Gordon B. Target optimization in transcranial direct current stimulation. Front Psychiatry. 2012 Oct 17;3:90. doi: 10.3389/fpsyt.2012.00090. eCollection 2012.

Reference Type: RESULT

PMID: 23087654 (View on PubMed)

Other Identifiers

1R21NS081646-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

506-2012-N

Identifier Type: -

Identifier Source: org_study_id