tDCS in People With Subthreshold Depression

Education University of Hong Kong

Status: Enrolling

Conditions: Subthreshold Depression

Treatments: Device: Personalized Experimental Transcranial Direct Current Stimulation (tDCS); Device: Sham Transcranial Direct Current Stimulation (tDCS); Device: Conventional Experimental Transcranial Direct Current Stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06517121

2023-2024-0048

Details and patient eligibility

About

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

Full description

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.

Enrollment: 204 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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204 participants in 3 patient groups

Personalised tDCS group

Experimental group

Description:

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

Treatment:

Device: Personalized Experimental Transcranial Direct Current Stimulation (tDCS)

Conventional tDCS group

Experimental group

Description:

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

Treatment:

Device: Conventional Experimental Transcranial Direct Current Stimulation (tDCS)

Sham control group

Sham Comparator group

Description:

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

Treatment:

Device: Sham Transcranial Direct Current Stimulation (tDCS)