HD-tDCS to Modulate Connectivity

Electricity; Effects Clinical Trial

Official title:

Modulating Functional Brain Connectivity Using High Definition Transcranial Direct Current Stimulation (HD-tDCS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05959551
• Other study ID #: HS24853
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: June 2023
• Source: University of Manitoba
• Contact: Ji Hyun Ko, PhD
• Phone: 2042930724
• Email: ji.ko[@]umanitoba.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Electricity; Effects

Intervention

Device:
• high definition transcranial direct current stimulation (HD-tDCS)
HD-tDCS will be provided for 20 minutes for each stimulation with peak intensity of 2mA.

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Natural Sciences and Engineering Research Council, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of functional connectivity	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	change of cerebral blood flow	Changes in Cerebral Blood Flow (estimated using pseudo continuous arterial spin labeling )	12-16 minutes after the stimulation contrasting baseline (before stimulation)
Secondary	Toronto Mindfulness Scale (curiosity)	mindfulness scale for curiosity. min: 0, max: 30. Higher score means higher curiosity-mindfulness.	Baseline, then within 1-2 hours from stimulation
Secondary	Toronto Mindfulness Scale (decentering)	mindfulness scale for decentering. min: 0, max: 35. Higher score means higher decentering-mindfulness.	Baseline, then within 1-2 hours from stimulation