HD-tDCS to Modulate Connectivity

NCT05959551 | Recruiting

• 1 other identifier: HS24853
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Electricity; Effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• change of cerebral blood flow

  12-16 minutes after the stimulation contrasting baseline (before stimulation)

• Toronto Mindfulness Scale (curiosity)

  Baseline, then within 1-2 hours from stimulation

• Toronto Mindfulness Scale (decentering)

  Baseline, then within 1-2 hours from stimulation

Study Arms (5)

left DLPFC stimulation

EXPERIMENTAL

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.

Device: high definition transcranial direct current stimulation (HD-tDCS)

right DLPFC stimulation

EXPERIMENTAL

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.

Device: high definition transcranial direct current stimulation (HD-tDCS)

left IPL stimulation

EXPERIMENTAL

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.

Device: high definition transcranial direct current stimulation (HD-tDCS)

VLPFC-PCC stimulation

EXPERIMENTAL

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.

Device: high definition transcranial direct current stimulation (HD-tDCS)

Sham stimulation

SHAM COMPARATOR

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.

Device: high definition transcranial direct current stimulation (HD-tDCS)

Interventions

high definition transcranial direct current stimulation (HD-tDCS) DEVICE

HD-tDCS will be provided for 20 minutes for each stimulation with peak intensity of 2mA.

Sham stimulation; VLPFC-PCC stimulation; left DLPFC stimulation; left IPL stimulation; right DLPFC stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All other than excluded.

You may not qualify if:

• History or susceptibility to any neurological or psychiatric diseases, particularly seizures
• abnormal MRI
• metal implants or a cardiac pacemaker
• pregnant or breastfeeding women

Sponsors & Collaborators

• Natural Sciences and Engineering Research Council, Canada: collaborator
• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 0J9, Canada

RECRUITING

Central Study Contacts

Ji Hyun Ko, PhD

CONTACT

2042930724; ji.ko@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization will happen after baseline assessment. After-intervention assessment will only consist of self-report and computerized assessment. Participants will not aware of the treatment group that they were assigned to.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4 active treatment groups + 1 inactive treatment group

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 25, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)