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Mechanism and Dosimetry Exploration in TES Magnetic Resonance Current Mapping Methods (TES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772210
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Arizona State University

Brief Summary:
In this study the investigators will explore dosimetry in transcranial electrical stimulation using a novel magnetic resonance imaging technique that can determine how electrical stimulation distributes within the brain. The investigators will then combine this imaging technique with functional MR imaging to attempt mechanistic associations. If successful, the study outcomes will be an improved understanding of the interactions between electric current distributions and structures presumed to be targeted by stimulation.

Condition or disease Intervention/treatment Phase
Transcranial Direct Current Stimulation Device: tDCS Other: Sham Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

Structural (T1-weighted) and high angular resolution diffusion images of participant heads will be obtained. Current density distributions in normal participants will be imaged using an F3-F4 montage at three different current intensities. Measures will be repeated at intervals of at least one week. Each time, the montage will be reapplied and subjects re-imaged. Because the imaging method is quantitative, these measures will be used to provide an indication of baseline replicability. Both intra- and inter-subject variations in measured current and electric field distributions will be determined.

Participant performance on a 3-back/0-back memory task will be compared in both Sham and Active subjects, using either 1, 1.5 or 2 mA intensity stimulation.

Masking: Single (Participant)
Masking Description: Device used to apply stimulation can be operated in SHAM mode, where subject experiences sensation of the tDCS stimulation starting, but the device is turned off shortly after SHAM mode initiates.
Primary Purpose: Basic Science
Official Title: Mechanism and Dosimetry Exploration in Transcranial Electrical Stimulation Using Magnetic Resonance Current Mapping Methods
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Active Comparator: Current Intensity 1 mA
tDCS will be administered at an intensity of 1 mA to locations F3-F4, and fMRI response during performance of a 3-back/0-back memory task will be assessed.
Device: tDCS
Current will be administered to subject groups as specified in arm descriptions.

Sham Comparator: Sham 1 mA
Determine fMRI response during performance of a 3-back/0-back memory task with sham 1 mA tDCS.
Other: Sham
Apparent Stimulation administered

Active Comparator: Current Intensity 1.5 mA
tDCS will be administered at an intensity of 1.5 mA to locations F3-F4, and fMRI response during performance of a 3-back/0-back memory task will be assessed.
Device: tDCS
Current will be administered to subject groups as specified in arm descriptions.

Sham Comparator: Sham 1.5 mA
Determine fMRI response during performance of a 3-back/0-back memory task with sham 1.5 mA tDCS.
Other: Sham
Apparent Stimulation administered

Active Comparator: Current Intensity 2 mA
tDCS will be administered at an intensity of 2 mA to locations F3-F4, and fMRI response during performance of a 3-back/0-back memory task will be assessed.
Device: tDCS
Current will be administered to subject groups as specified in arm descriptions.

Sham Comparator: Sham 2 mA
Determine fMRI response during performance of a 3-back/0-back memory task with sham 2 mA tDCS.
Other: Sham
Apparent Stimulation administered

Experimental: Structural, Diffusion and MREIT Imaging

Structural and High angular resolution diffusion weighted imaging will be performed.

Magnetic Resonance Electrical Impedance Tomography imaging will be performed using electrode locations F3-F4.

Device: tDCS
Current will be administered to subject groups as specified in arm descriptions.




Primary Outcome Measures :
  1. Replicability [ Time Frame: 3 weeks ]
    MREIT data will be obtained multiple times for each subject

  2. Comparison of measured current distribution with fMRI result [ Time Frame: 2 weeks ]
    Measured current distributions will be correlated with fMRI results and task accuracies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • We will include neurologically normal volunteer subjects between 18-30 years of age in the study, minors will not be targeted.
  • English as Native Language

Exclusion Criteria:

  • Adults who are unable to consent will not be included in the study.
  • Pregnancy
  • Subjects will not have any implanted or attached metallic devices.
  • Appreciable deficits in hearing
  • Appreciable problems with articulation
  • Neuroanatomic abnormality
  • Any neurological disorder associated with cognitive impairment.
  • Any implanted cardiac pacemaker
  • Dementia or Mini-Mental State Exam <24
  • Low estimated verbal intelligence per WTAR
  • Active or Prior history of Seizure Disorder
  • Family History of Seizure disorder
  • Prescribed Seizure inducing medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772210


Contacts
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Contact: Rosalind J Sadleir, PhD 3528710036 rjsadleir@gmail.com

Locations
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United States, Arizona
Arizona State University Recruiting
Tempe, Arizona, United States, 85287-9709
Contact: Rosalind Sadleir, PhD    352-871-0036    rjsadleir@gmail.com   
United States, Florida
University of Florida Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Thomas H Mareci, DPhil         
Sponsors and Collaborators
Arizona State University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Rosalind J Sadleir, PhD Arizona State University

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Responsible Party: Arizona State University
ClinicalTrials.gov Identifier: NCT03772210    
Other Study ID Numbers: STUDY00006012
RF1MH114290 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared via the NIMH Data Archive (NDAR)
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: After analysis and deidentification, data will be uploaded to NDAR
Access Criteria: Available to qualified researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arizona State University:
fMRI
mechanism
tDCS
neuromodulation