HD-tDCS to Modulate Connectivity

Sponsor
University of Manitoba (Other)
Overall Status
Recruiting
CT.gov ID
NCT05959551
Collaborator
Natural Sciences and Engineering Research Council, Canada (Other)
100
1
5
26
3.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: high definition transcranial direct current stimulation (HD-tDCS)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
4 active treatment groups + 1 inactive treatment group4 active treatment groups + 1 inactive treatment group
Masking:
Single (Participant)
Masking Description:
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.
Primary Purpose:
Basic Science
Official Title:
Modulating Functional Brain Connectivity Using High Definition Transcranial Direct Current Stimulation (HD-tDCS)
Actual Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Aug 31, 2025
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. change of functional connectivity [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 Outcome Measures

  1. change of cerebral blood flow [12-16 minutes after the stimulation contrasting baseline (before stimulation)]

    Changes in Cerebral Blood Flow (estimated using pseudo continuous arterial spin labeling )

  2. Toronto Mindfulness Scale (curiosity) [Baseline, then within 1-2 hours from stimulation]

    mindfulness scale for curiosity. min: 0, max: 30. Higher score means higher curiosity-mindfulness.

  3. Toronto Mindfulness Scale (decentering) [Baseline, then within 1-2 hours from stimulation]

    mindfulness scale for decentering. min: 0, max: 35. Higher score means higher decentering-mindfulness.

Eligibility Criteria

Criteria

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

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
  • Natural Sciences and Engineering Research Council, Canada

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT05959551
Other Study ID Numbers:
  • HS24853
First Posted:
Jul 25, 2023
Last Update Posted:
Jul 25, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Jul 25, 2023