NCT03027869

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

June 28, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

2.7 years

First QC Date

January 16, 2017

Last Update Submit

March 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Stroop task performance

    immediate (less than 60 minutes)

Study Arms (3)

Real Left DLPFC tDCS

ACTIVE COMPARATOR

Real tDCS on the left dorsolateral prefrontal cortex

Device: transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

30sec ramp-up and 30sec ramp-down

Device: transcranial direct current stimulation

Real Right DLPFC tDCS

ACTIVE COMPARATOR

Real tDCS on the right dorsolateral prefrontal cortex

Device: transcranial direct current stimulation

Interventions

15 minute anodal stimulation 1.5mA

Real Left DLPFC tDCSReal Right DLPFC tDCSSham tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • N/A

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0J9, Canada

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 16, 2017

First Posted

January 23, 2017

Study Start

June 28, 2017

Primary Completion

March 11, 2020

Study Completion

December 31, 2025

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations