Expired Study
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Gainesville, Florida 32610


Purpose:

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 summary:

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.


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.


Study is Available At:


Original ID:

506-2012-N


NCT ID:

NCT02453763


Secondary ID:

1R21NS081646-01A1


Study Acronym:

tDCS


Brief Title:

In Vivo Imaging of Therapeutic Electric Current Flow


Official Title:

In Vivo Imaging of Therapeutic Electric Current Flow


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

30 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Florida


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

17


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:June 2015
Completion Date:July 6, 2017
Completion Type:Actual
Primary Completion Date:July 6, 2017
Primary Completion Type:Actual
Verification Date:April 2018
Last Changed Date:April 4, 2018
First Received Date:May 21, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Magnetic Resonance Imaging (MRI) of therapeutic current flow
Time Frame:Day 1
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Device
Name:Transcranial direct current stimulation
Description: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.
Arm Name:Transcranial direct current stimulation
Other Name:Noninvasive Brain Stimulation
Intervention Type:Procedure
Name:MRI
Description: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.
Arm Name:Transcranial direct current stimulation
Other Name:Magnetic Resonance Imaging

Study Arms

Study Arm Type:Other
Arm Name:Transcranial direct current stimulation
Description:All participants will receive transcranial direct current stimulation and an magnetic resonance imaging (MRI).

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Florida
Agency Class:Other
Agency Type:Collaborator
Agency Name:Arizona State University

Samples and Retentions

Study Population: 24 normal adult subjects will be assessed.
Sample Method:Probability Sample

Study References

Reference Type:Reference
Citation: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.
PMID:23435264
Reference Type:Reference
Citation: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.
PMID:23737862
Reference Type:Reference
Citation: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.
PMID:25177279
Reference Type:Results Reference
Citation: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.
PMID:23087654

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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