Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) on Depressed Patients

NCT05539131 | Completed Results

• 1 other identifier: 2022-0225-002
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 5

Brief Summary

Purpose of research: It aims to demonstrate the effectiveness of transcranial direct current stimulation (tDCS) in the clinical domain for patients with depression and to optimize home-based e-medication technology.

Conditions

Depression

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Depressive Symptoms on Beck Depression Inventory-II (BDI-II) at Week 13

  It is a self-report depression scale of 21 questions, which the score range from 0 to 63, and it is required to select a sentence that is appropriate for you among 4 descriptions for each question, and the total score is 0 to 63 points for each question. 0\~13: Minimal 14\~19: Mild depression 20\~28: Moderate depression 29\~63: Severe depression

  From Visit1(baseline) to 91 days

• Change From Baseline in Depressive Symptoms on Montgomery-Asberg Depression Rating Scale (MADRS) at Week 13

  It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. It evaluates 10 items such as apparent sadness, voluntarily reporting sadness, internal tension, sleep loss, loss of appetite, laziness, loss of feeling, pessimistic thinking, and suicide accident, and the total score is 0 to 60 points per question. The total score ranges from 0 to 60 points. 0-6 indicate an absence of symptoms 7-19 Mild depression 20-34 Moderate depression 35-60 Severe depression

  From Visit1(baseline) to 91 days

Secondary Outcomes (4)

• Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13

  From Visit1(baseline) to 91 days

• Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13

  From Visit1(baseline) to 91 days

• Change From Baseline in Depressive Symptoms on Clinical Global Impression-Severity of Illness Scale (CGI-SI) at Week 13

  From Visit1(baseline) to 91 days

• Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13

  From Visit1(baseline) to 91 days

Study Arms (2)

active transcranial direct current stimulation (tDCS)

ACTIVE COMPARATOR

daily active transcranial direct current stimulation (tDCS) use for 6 weeks

Device: transcranial direct current stimulation (tDCS)

sham transcranial direct current stimulation (tDCS)

SHAM COMPARATOR

daily active transcranial direct current stimulation (tDCS) use for 3 weeks + daily sham transcranial direct current stimulation (tDCS) use for 3 weeks

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

Transcranial direct current stimulation (tDCS) suppresses excitability and regulates excitability of neurons by injecting a small amount of current through electrodes attached to the scalp.

active transcranial direct current stimulation (tDCS); sham transcranial direct current stimulation (tDCS)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female aged 19 to 65 with mild and moderate Major depressive disorder (MDD)

You may not qualify if:

• Those diagnosed with Post-traumatic stress disorder (PTSD), Obsessive compulsive disorder (OCD), bipolar or psychotic major depressive disorder, high suicide risk, Electroencephalography (EEG) and DC stimulation electrode attachment problems (such as scalp deformity, inflammatory response or other dermatological problems), Transcranial direct current stimulation (tDCS) medical device taboos (such as head metal plate insertion), clinical trials that have been inadequate for clinical trials

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (5)

Hallym Univsity Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

Location

National Health Insurance Service Ilsanhospital

Goyang-si, Gyeonggi-do, 10444, South Korea

Location

Myongji Hospital

Goyang-si, Gyeonggi-do, 10475, South Korea

Location

Catholic Kwandong University International St. Mary'S Hospital

Incheon, Gyeonggi-do, 22711, South Korea

Location

Yongin Severance Hospital, Yonsei University College of Medicine

Yongin, Gyeonggi-do, 16995, South Korea

Location

Related Publications (4)

• Oh J, Jang KI, Jeon S, Chae JH. Effect of Self-administered Transcranial Direct Stimulation in Patients with Major Depressive Disorder: A Randomized, Single-blinded Clinical Trial. Clin Psychopharmacol Neurosci. 2022 Feb 28;20(1):87-96. doi: 10.9758/cpn.2022.20.1.87.

  PMID: 35078951 BACKGROUND

• Fregni F, Nitsche MA, Loo CK, Brunoni AR, Marangolo P, Leite J, Carvalho S, Bolognini N, Caumo W, Paik NJ, Simis M, Ueda K, Ekhitari H, Luu P, Tucker DM, Tyler WJ, Brunelin J, Datta A, Juan CH, Venkatasubramanian G, Boggio PS, Bikson M. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel. Clin Res Regul Aff. 2015 Mar 1;32(1):22-35. doi: 10.3109/10601333.2015.980944.

  PMID: 25983531 BACKGROUND

• Wang J, Luo H, Schulke R, Geng X, Sahakian BJ, Wang S. Is transcranial direct current stimulation, alone or in combination with antidepressant medications or psychotherapies, effective in treating major depressive disorder? A systematic review and meta-analysis. BMC Med. 2021 Dec 17;19(1):319. doi: 10.1186/s12916-021-02181-4.

  PMID: 34915885 BACKGROUND

• Park HY, Park J, Roh D, Jhung K, Chang JG, Park S, Ryu JS, Do G, Lee K, Park JY, Kim WJ. Real-World Effects of Home-Based Transcranial Direct Current Stimulation in Depression: A Randomized Controlled Trial of 3-Week Versus 6-Week Protocols. Brain Behav. 2025 Dec;15(12):e71119. doi: 10.1002/brb3.71119.

  PMID: 41376187 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Woo Jung Kim
• Organization: Yongin Severance Hospital

woojungkim@yuhs.ac

01092827943

Study Officials

• Woo Jung Kim

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 14, 2022
• Study Start: November 4, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 11, 2025
• Results First Posted: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the completion of the study, the data will be available for 3 years.
• Access Criteria: For data security, encrypted communication methods will be used and restricted access to only authorized licensed personnel on the e-CRF domain.

Locations

KR (5)