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Normal Brain Imaging Database for Brain Disorder Studies (Normal_tDCS)

Primary Purpose

Healthy

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Arm Label

Real Left DLPFC tDCS

Sham tDCS

Real Right DLPFC tDCS

Arm Description

Real tDCS on the left dorsolateral prefrontal cortex

30sec ramp-up and 30sec ramp-down

Real tDCS on the right dorsolateral prefrontal cortex

Outcomes

Primary Outcome Measures

functional connectivity
The functional connectivity of the right caudate nucleus will be estimated using graph theory analysis technique of resting-state fMRI.

Secondary Outcome Measures

Stroop task performance
the executive function that is thought to involve the caudate nucleus will be examined

Full Information

First Posted
January 16, 2017
Last Updated
May 10, 2023
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT03027869
Brief Title
Normal Brain Imaging Database for Brain Disorder Studies
Acronym
Normal_tDCS
Official Title
Normal Brain Imaging Database for Brain Disorder Studies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real Left DLPFC tDCS
Arm Type
Active Comparator
Arm Description
Real tDCS on the left dorsolateral prefrontal cortex
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
30sec ramp-up and 30sec ramp-down
Arm Title
Real Right DLPFC tDCS
Arm Type
Active Comparator
Arm Description
Real tDCS on the right dorsolateral prefrontal cortex
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
15 minute anodal stimulation 1.5mA
Primary Outcome Measure Information:
Title
functional connectivity
Description
The functional connectivity of the right caudate nucleus will be estimated using graph theory analysis technique of resting-state fMRI.
Time Frame
immediate (less than 30 minutes)
Secondary Outcome Measure Information:
Title
Stroop task performance
Description
the executive function that is thought to involve the caudate nucleus will be examined
Time Frame
immediate (less than 60 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0J9
Country
Canada

12. IPD Sharing Statement

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Normal Brain Imaging Database for Brain Disorder Studies

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