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

Demonstration Study of the Effect of the Transcranial Direct Current Stimulation (tDCS) for the Patients With Depression in Clinical Fields

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Device: transcranial direct current stimulation (tDCS)

Detailed Description

As a home-based clinical empirical study of transcranial direct current stimulation for depressed patients, male and female subjects aged 19 to 65 who meet the criteria for mild and moderate Major depressive disorder (MDD) were enrolled, and real-world data (RWD) was obtained through self-application of transcranial direct current stimulation (tDCS) at home for 6 weeks. This is a study that secures and derives real-world evidence (RWE) that can be applied to clinical practice.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Gangwon-do
    • Chuncheon, Gangwon-do, South Korea, 24253
      • Hallym Univsity Chuncheon Sacred Heart Hospital
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, South Korea, 10475
      • Myongji Hospital
    • Goyang-si, Gyeonggi-do, South Korea, 10444
      • National Health Insurance Service Ilsanhospital
    • Incheon, Gyeonggi-do, South Korea, 22711
      • Catholic Kwandong University International St. Mary's Hospital
    • Yongin, Gyeonggi-do, South Korea, 16995
      • Yongin Severance Hospital, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active transcranial direct current stimulation (tDCS); daily active transcranial direct current stimulation (tDCS) use for 6 weeks	Device: transcranial direct current stimulation (tDCS); 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.
Sham Comparator: sham transcranial direct current stimulation (tDCS); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Depressive Symptoms on Epidemiologic Studies Depression Scale Revised (CESD-R) at Week 13	Epidemiologic Studies Depression Scale Revised test was revised to reflect the major depressive illustration diagnostic criteria for the evaluation of depression. Items reflecting anaesthesia, mental exercise delay/anxiety, and suicide accidents have been added, and are measured as 0 to 4 points per question on a self-report 20 question scale. The score ranges from 0~80 points. . A score equal to or above 16 indicates a person at risk for clinical depression.	From Visit1(baseline) to 91 days
Change From Baseline in Depressive Symptoms on Hamilton Anxiety Scale (HAM-A) at Week 13	The scale developed by Hamilton consists of 14 questions, and is evaluated by the clinician on a 5-point Likert scale of a semi-structured interview tool. The score ranges from 0~56 points. Each item is scored on a scale of 0 (not present) to 4 (severe), with total score range of 0-56, where <17 indi- cates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.	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	It was developed for evaluation of symptom severity, treatment response, and treatment effectiveness in patients with psychiatric disorders (Guy W, 1976) and scored 0-7 points based on the overall impression of the subject's symptoms and treatment response compared to typical patients with the disease. It was developed for evaluation of symptom severity, treatment response, and treatment effectiveness in patients with psychiatric disorders (Guy W, 1976) and scored 0-7 points based on the overall impression of the subject's symptoms and treatment response compared to typical patients with the disease. The score ranges from 0~7 points. 1: normal, not at all ill 2: borderline mentally ill 3: mildly ill 4: moderately ill 5: markedly ill 6: severely ill 7: extremely ill	From Visit1(baseline) to 91 days
Change From Baseline in Depressive Symptoms on Digit Symbol Substitution Test (DSST) at Week 13	t is possible to measure high-dimensional cognitive functions such as perceptual organization ability and visual movement coordination, and examine attentional concentration, visual short-term memory, and mental movement speed. A post-marketing survey (PMS) on a new mechanism of anti-depressant (vortioxetine) is used to measure cognitive function before and after the use of the antidepressant in depressed patients. The score is the number of correct number-symbol matches achieved in 90 s. The score ranges from 0~93 points.	From Visit1(baseline) to 91 days

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Woo Jung Kim, Severance Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 9, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: 2022-0225-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Personal information collected for research purposes shall be kept anonymously in a safe place within the institute to be managed so that personal information is not exposed.
• IPD Sharing Time Frame: After the completion of the study, the data will be available for 3 years.
• IPD Sharing Access Criteria: For data security, encrypted communication methods will be used and restricted access to only authorized licensed personnel on the e-CRF domain.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No