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HD-tDCS to Modulate Connectivity

NCT ID: NCT05959551

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-08-31

Brief Summary

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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

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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.

Conditions

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Electricity; Effects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 active treatment groups + 1 inactive treatment group
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type EXPERIMENTAL

high definition transcranial direct current stimulation (HD-tDCS)

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

high definition transcranial direct current stimulation (HD-tDCS)

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

high definition transcranial direct current stimulation (HD-tDCS)

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

high definition transcranial direct current stimulation (HD-tDCS)

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

high definition transcranial direct current stimulation (HD-tDCS)

Intervention Type DEVICE

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

Interventions

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high definition transcranial direct current stimulation (HD-tDCS)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Natural Sciences and Engineering Research Council, Canada

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Manitoba

Winnipeg, Manitoba, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Ji Hyun Ko, PhD

Role: CONTACT

Phone: 2042930724

Email: [email protected]

Facility Contacts

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Ji Hyun Ko, PhD

Role: primary

Other Identifiers

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HS24853

Identifier Type: -

Identifier Source: org_study_id