Mechanism and Dosimetry Exploration in TES Magnetic Resonance Current Mapping Methods

NCT03772210 | Completed

• 2 other identifiers: STUDY00006012RF1MH114290
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 2

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.

Conditions

Transcranial Direct Current Stimulation

Keywords

fMRI; mechanism; tDCS; neuromodulation

Outcome Measures

Primary Outcomes (2)

• Replicability

  MREIT data will be obtained multiple times for each subject

  3 weeks

• Comparison of measured current distribution with fMRI result

  Measured current distributions will be correlated with fMRI results and task accuracies

  2 weeks

Study Arms (7)

Current Intensity 1 mA

ACTIVE COMPARATOR

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

Sham 1 mA

SHAM COMPARATOR

Determine fMRI response during performance of a 3-back/0-back memory task with sham 1 mA tDCS.

Other: Sham

Current Intensity 1.5 mA

ACTIVE COMPARATOR

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

Sham 1.5 mA

SHAM COMPARATOR

Determine fMRI response during performance of a 3-back/0-back memory task with sham 1.5 mA tDCS.

Other: Sham

Current Intensity 2 mA

ACTIVE COMPARATOR

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

Sham 2 mA

SHAM COMPARATOR

Determine fMRI response during performance of a 3-back/0-back memory task with sham 2 mA tDCS.

Other: Sham

Structural, Diffusion and MREIT Imaging

EXPERIMENTAL

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

Interventions

tDCS DEVICE

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

Current Intensity 1 mA; Current Intensity 1.5 mA; Current Intensity 2 mA; Structural, Diffusion and MREIT Imaging

Sham OTHER

Apparent Stimulation administered

Sham 1 mA; Sham 1.5 mA; Sham 2 mA

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Arizona State University

Tempe, Arizona, 85287-9709, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Rosalind J Sadleir, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 11, 2018
• Study Start: January 3, 2019
• Primary Completion: May 31, 2022
• Study Completion: June 9, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After analysis and deidentification, data will be uploaded to NDAR
• Access Criteria: Available to qualified researchers.

Locations

US (2)