Normal_tDCS: Normal Brain Imaging Database for Brain Disorder Studies

• Sponsor: University of Manitoba (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03027869
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 61.1
• Patients Per Site Per Month: 0.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: transcranial direct current stimulation	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Normal Brain Imaging Database for Brain Disorder Studies
• Actual Study Start Date: Jun 28, 2017
• Actual Primary Completion Date: Mar 11, 2020
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. functional connectivity [immediate (less than 30 minutes)]

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

Secondary Outcome Measures

1. Stroop task performance [immediate (less than 60 minutes)]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Manitoba	Winnipeg	Manitoba	Canada	R3E 0J9

Sponsors and Collaborators

• University of Manitoba

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ji Hyun Ko, PhD, Assistant Professor, University of Manitoba
• ClinicalTrials.gov Identifier: NCT03027869
• Other Study ID Numbers: B2016:074
• First Posted: Jan 23, 2017
• Last Update Posted: Jun 13, 2022
• Last Verified: Jun 1, 2022

• 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
• Additional relevant MeSH terms: Brain Diseases

Study Results

No Results Posted as of Jun 13, 2022