TDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals.

NCT06294184 | Recruiting

• 1 other identifier: Guangzhou PH tDCS in SD
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the mechanisms of the effect of transcranial direct current stimulation (tDCS) in alleviating subthreshold depressive symptoms in young individuals, and individualized outcome prediction is carried out.

Conditions

Subthreshold Depression; Young People; Transcranial Direct Current Stimulation

Keywords

Resting-state brain functional network; Social emotion

Outcome Measures

Primary Outcomes (1)

• The effect of tDCS in alleviating subthreshold depressive symptoms

  In young individuals with subthreshold depressive symptoms, we used a latent growth model to test whether 10 trials of tDCS for stimulation of lDLPFC or rVLPFC had immediate and sustained (1 \& 3 months follow-up) effects on altered depressive symptoms, LPFC-DMN function regulation, positive and negative emotional processing. The latent growth curve model can fit the data well at multiple time points and analyze the correlation of the rate of change of multiple variables. We will measure participants' emotions using the original word score that has been pre-experimentally confirmed, and use the Dynamic Causal Modelling to calculate the resting-state functional regulation of LPFC to DMN (rsFC intensity from LPFC to DMN). We randomized young individuals 1:1:1 to lDLPFC, rVLPFC, and pseudo-stimulation (sham) to test the tDCS effect.

  2 weeks, 1 month and 3 months

Secondary Outcomes (2)

• Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms

  2 weeks, 1 month and 3 months

• To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms

  2 weeks, 1 month and 3 months

Study Arms (3)

lDLPFC tdcs stimulation group

EXPERIMENTAL

The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3, cathode is on the FP2.

Device: tdcs lDLPFC

rVLPFC tdcs stimulation group

EXPERIMENTAL

The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F6, cathode is on the FP1.

Device: tdcs rVLPFC

Sham group

SHAM COMPARATOR

The current only persist in the fisrt 30s, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3/F6, cathode is on the FP2/1.

Device: Sham

Interventions

tdcs lDLPFC DEVICE

The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3, cathode is on the FP2.

lDLPFC tdcs stimulation group

tdcs rVLPFC DEVICE

The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F6, cathode is on the FP1.

rVLPFC tdcs stimulation group

Sham DEVICE

The current only persist in the fisrt 30s, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3/F6, cathode is on the FP2/1.

Sham group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) Be between the ages of 12-25;
• \) is right-handed on the Edinburgh Handedness Inventory;
• \) 2-4 of the 9 depressive symptoms defined by the American Diagnostic and Statistical Manual of Diseases, Fifth Edition (DSM-5), lasting more than 1 week; or more than 5 depressive symptoms lasting more than 1 week but less than 2 weeks (i.e., not meeting criteria for a major depressive episode) (by DSM-5 Clinical Semi-Definitive Interview (K-SADS-PL) (Gilbody et al., 2017, JAMA);
• \) Hamilton Depression Scale (HAMD-24) 24 points≥ 8 points, \< 24 points;
• \) Gender is not limited;
• \) Subjects and their families voluntarily participate and sign the informed consent form.

You may not qualify if:

• \) Individuals with the following diagnoses according to DSM-5: psychiatric disorders due to organic diseases, substance-related and addictive disorders, neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder (assessed by K-SADS-PL);
• \) Have two or more DSM-V-defined manic symptoms for 4 days but do not meet the criteria for hypomania or meet the DSM-V defined criteria for hypomanic symptoms for only 2-3 days;
• \) Severe or unstable physical illness;
• \) have a moderate or higher risk of suicide (as assessed by the Columbia Suicide Severity Scale);
• \) Received transcranial direct current stimulation in the past three months (continuous intervention time: \>2 weeks);
• \) Contraindications to transcranial direct current stimulation, such as brain implants, personal or family history of epilepsy;
• \) Magnetic resonance scanning is contraindicated, such as in vivo metal implants.

Sponsors & Collaborators

• Guangzhou Psychiatric Hospital: lead

Study Sites (1)

Guangzhou Brain hospital(Guangzhou Huiai Hospital)

Guangzhou, Guangdong, 510370, China

RECRUITING

Study Officials

• Kangguang Lin, M.D;PH.D

  The Affiliated Brain Hospital of Guangzhou Medical University

  STUDY DIRECTOR

• Robin Shao, Ph.D

  The Affiliated Brain Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kangguang Lin, M.D;Ph.D

CONTACT

86-02081268189; linkangguang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: November 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)