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Clinical Trials/NCT05959551
NCT05959551
Recruiting
Not Applicable

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

University of Manitoba2 sites in 1 country100 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
high definition transcranial direct current stimulation (HD-tDCS)
Conditions
Electricity; Effects
Sponsor
University of Manitoba
Enrollment
100
Locations
2
Primary Endpoint
change of functional connectivity
Status
Recruiting
Last Updated
yesterday

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
August 31, 2026
Last Updated
yesterday
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

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

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.

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

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.

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

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.

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

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.

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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 Sites (2)

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