Normal Brain Imaging Database for Brain Disorder Studies (Normal_tDCS)

Healthy volunteers will be recruited. All subjects will be tested a battery of neuropsychological tests, then undergo fluorodeoxyglucose-positron emission tomography (PET) and magnetic resonance imaging (MRI). During the PET and MRI, they will be stimulated with transcranial direct current stimulation (tDCS) for 15 minutes. A third of subjects will receive real tDCS on the left prefrontal cortex, a third on the right prefrontal cortex, and the other third will receive sham tDCS.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Device: transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0J9
      • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• N/A

Exclusion Criteria:

• History of any neurological or psychiatric diseases;
• Abnormal MRI;
• metal implants or a cardiac pacemaker;
• Pregnant or breastfeeding women (female subjects of child bearing potential will be screened for pregnancy before MRI imaging).
• severe hypertension.
• cardiovascular disease.
• Family history of epilepsy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Real Left DLPFC tDCS; Real tDCS on the left dorsolateral prefrontal cortex	Device: transcranial direct current stimulation; 15 minute anodal stimulation 1.5mA
Sham Comparator: Sham tDCS; 30sec ramp-up and 30sec ramp-down	Device: transcranial direct current stimulation; 15 minute anodal stimulation 1.5mA
Active Comparator: Real Right DLPFC tDCS; Real tDCS on the right dorsolateral prefrontal cortex	Device: transcranial direct current stimulation; 15 minute anodal stimulation 1.5mA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional connectivity	The functional connectivity of the right caudate nucleus will be estimated using graph theory analysis technique of resting-state fMRI.	immediate (less than 30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroop task performance	the executive function that is thought to involve the caudate nucleus will be examined	immediate (less than 60 minutes)

Collaborators and Investigators

• Sponsor: University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2017
• Primary Completion (Actual): March 11, 2020
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: January 18, 2017
• First Posted (Estimated): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Brain Diseases
• Other Study ID Numbers: B2016:074

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes