- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05959551
HD-tDCS to Modulate Connectivity
April 27, 2026 updated by: University of Manitoba
Modulating Functional Brain Connectivity Using High Definition Transcranial Direct Current Stimulation (HD-tDCS)
The purpose of the proposed study is to broaden our understanding on the neural effects of High Definition Transcranial Direct Current Stimulation (HD-tDCS) so that its clinical effects can be further improved.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Normal healthy individuals will be recruited and undergo a standardized neuropsychological assessment (ANAM, MoCA, BDI-II, ToMS, and MAAS) and magnetic resonance imaging (MRI).
During MRI, HD-tDCS will be applied.
Four different stimulation targets will be investigated, and subjects will be randomly assigned for each target groups or sham group.
After HD-tDCS/MRI session, subjects will be re-assessed with standardized neuropsychological tests.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ji Hyun Ko, PhD
- Phone Number: 2042930724
- Email: ji.ko@umanitoba.ca
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 0J9
- Recruiting
- University of Manitoba
-
Contact:
- Ji Hyun Ko, PhD
- Phone Number: 204-318-2566
- Email: ji.ko@umanitoba.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- All other than excluded.
Exclusion Criteria:
- History or susceptibility to any neurological or psychiatric diseases, particularly seizures
- abnormal MRI
- metal implants or a cardiac pacemaker
- pregnant or breastfeeding women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: left DLPFC stimulation
HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels.
The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left dorsolateral prefrontal cortex (DLPFC; x=-44, y=10, z=30) with inward field orientation.
The peak current will not exceed 2 mA.
A constant current will be delivered for 20 minutes.
|
HD-tDCS will be provided for 20 minutes for each stimulation with peak intensity of 2mA.
|
|
Experimental: right DLPFC stimulation
HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels.
The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the right dorsolateral prefrontal cortex (DLPFC; x=+42, y=+14, z=+30) with inward field orientation.
The peak current will not exceed 2 mA.
A constant current will be delivered for 20 minutes.
|
HD-tDCS will be provided for 20 minutes for each stimulation with peak intensity of 2mA.
|
|
Experimental: left IPL stimulation
HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels.
The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left intraparietal lobe (IPL; x=-50, y=-36, z=+42) with inward field orientation.
The peak current will not exceed 2 mA.
A constant current will be delivered for 20 minutes.
|
HD-tDCS will be provided for 20 minutes for each stimulation with peak intensity of 2mA.
|
|
Experimental: VLPFC-PCC stimulation
HD-tDCS will be used to deliver direct current to the target via rubber electrodes and HD-tDCS gels.
The 9 electrodes (8 channels + 1 ground) positions and current intensity will be determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left ventrolateral prefrontal cortex (VLPFC; x=-50, y=+26, z=+8) and posterior cingulate cortex (PCC; x=1, y=-61, z=38) with inward field orientation.
The peak current will not exceed 2 mA.
A constant current will be delivered for 20 minutes.
|
HD-tDCS will be provided for 20 minutes for each stimulation with peak intensity of 2mA.
|
|
Sham Comparator: Sham stimulation
One of the above three targets will be randomly selected.
The current will be applied for 30 seconds ramp-up followed by 30 seconds ramp-down.
|
HD-tDCS will be provided for 20 minutes for each stimulation with peak intensity of 2mA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change of functional connectivity
Time Frame: 0-11 minutes after the stimulation contrasting baseline (before stimulation)
|
Changes in seed-based connectivity originating from the targeted brain regions immediately after the brain stimulation
|
0-11 minutes after the stimulation contrasting baseline (before stimulation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change of cerebral blood flow
Time Frame: 12-16 minutes after the stimulation contrasting baseline (before stimulation)
|
Changes in Cerebral Blood Flow (estimated using pseudo continuous arterial spin labeling )
|
12-16 minutes after the stimulation contrasting baseline (before stimulation)
|
|
Toronto Mindfulness Scale (curiosity)
Time Frame: Baseline, then within 1-2 hours from stimulation
|
mindfulness scale for curiosity.
min: 0, max: 30.
Higher score means higher curiosity-mindfulness.
|
Baseline, then within 1-2 hours from stimulation
|
|
Toronto Mindfulness Scale (decentering)
Time Frame: Baseline, then within 1-2 hours from stimulation
|
mindfulness scale for decentering.
min: 0, max: 35.
Higher score means higher decentering-mindfulness.
|
Baseline, then within 1-2 hours from stimulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2023
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
June 20, 2023
First Submitted That Met QC Criteria
July 17, 2023
First Posted (Actual)
July 25, 2023
Study Record Updates
Last Update Posted (Actual)
May 1, 2026
Last Update Submitted That Met QC Criteria
April 27, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- HS24853
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
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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