tDCS in People With Subthreshold Depression

NCT ID: NCT06517121

Last Updated: 2026-02-02

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

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-16

Study Completion Date

2027-01-31

Brief Summary

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This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness, mood and depressiveness in people with subthreshold depression.

Detailed Description

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Depression-prone individuals will be invited and allocated to three groups, either the personalised transcranial direct current stimulation (tDCS) group, the conventional tDCS group, or the sham control group. After screening and at baseline prior to the tDCS sessions, participants will complete tests and questionnaires on depression symptoms, loneliness and mood. Eligible participants will also be invited to receive functional magnetic resonance imaging (MRI) in a 3-Tesla MRI scanner. There will be a maximum of 10 sessions to be completed after the screening and baseline measures. For both personalised tDCS group and the conventional tDCS group, tDCS with 2 milliampere (mA) intensity will be delivered for 20 minutes in each session. For sham control group, the protocol will be similar, except that the stimulation only happens in the first 30 seconds in each session. Especially for participants allocated to the personalised tDCS group, the stimulation site for each individual in this group may vary, depending on their brain activations and connectivity. The anodal stimulation sites for participants allocated to the conventional tDCS group and the sham control group will be F3 within the left DLPFC. Immediately after and also 3-months after completing all the tDCS sessions, participants will be invited to complete again tests and questionnaires on depressive symptoms in addition to loneliness and mood. Eligible participants will also be invited to receive functional MRI scanning in the 3T MRI scanner again. Participants will also be prompted to self-report daily their loneliness and mood levels throughout the study.

Conditions

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Subthreshold Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Personalised tDCS group

Participants who are assigned to the personalised group will receive anodal tDCS over a individualized stimulation site.

Group Type EXPERIMENTAL

Personalized Experimental Transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity over personalized brain regions based on the particular neural correlates of socio-affective processing.

Conventional tDCS group

Participants who are assigned to the Conventional group will receive anodal tDCS over F3.

Group Type EXPERIMENTAL

Conventional Experimental Transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity with anode placed over F3.

Sham control group

Participants who are assigned to the Conventional group will receive sham tDCS. The active stimulation will be delivered for the first 30 seconds only.

Group Type SHAM_COMPARATOR

Sham Transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants assigned to the sham control group will only receive 30 seconds of active stimulation.

Interventions

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Personalized Experimental Transcranial Direct Current Stimulation (tDCS)

This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity over personalized brain regions based on the particular neural correlates of socio-affective processing.

Intervention Type DEVICE

Sham Transcranial Direct Current Stimulation (tDCS)

This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants assigned to the sham control group will only receive 30 seconds of active stimulation.

Intervention Type DEVICE

Conventional Experimental Transcranial Direct Current Stimulation (tDCS)

This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity with anode placed over F3.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* No histories of learning impairment, major psychiatric disorders including Major Depressive Disorder or neurological disorders
* At least primary school education
* Subthreshold depression

Exclusion Criteria

* On medication or treatments within 2 weeks prior to the beginning of the study that would affect the individual's brain, cognitive and affective functions
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Hong Kong

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role collaborator

Hong Kong Baptist University

OTHER

Sponsor Role collaborator

Education University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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WONG Man Lok Nichol

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nichol ML Wong, PhD

Role: PRINCIPAL_INVESTIGATOR

Education University of Hong Kong

Locations

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The Education University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Nichol ML Wong, PhD

Role: CONTACT

852-29487431

Facility Contacts

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Nichol ML Wong, PhD

Role: primary

852-29487431

Other Identifiers

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2023-2024-0048

Identifier Type: -

Identifier Source: org_study_id

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