Transcranial Direct Current Stimulation for Depression

NCT07500064 | Recruiting DMC

• 1 other identifier: AHMU-DLPFC/DMPFC-DEPRESSION
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Depression is a common mental disorder characterized by persistent low mood and anhedonia. Pharmacological and psychotherapeutic treatments demonstrate only moderate efficacy. Non-invasive brain stimulation techniques offer novel therapeutic approaches. Among these, transcranial direct current stimulation (tDCS) holds advantages due to its simplicity, low cost, and minimal side effects, exhibiting good efficacy and tolerability in depression treatment. The dorsolateral prefrontal cortex (DLPFC), a core region of the cognitive control network, serves as a traditional target for non-invasive brain stimulation in depression and plays a crucial role in positive affect (PA) processing. Conversely, the dorsomedial prefrontal cortex (DMPFC), a central region of the default mode network, participates in negative self-referential processing and negative affect (NA) regulation, demonstrating potential as a novel therapeutic target. Objective: Given the distinct roles of DLPFC and DMPFC in separate affective regulation networks, this study aims to investigate the differential effects of different tDCS targets on emotional regulation in patients with depression. Design: This study employed a randomized, double-blind, controlled design. Participants diagnosed with depression will be randomly assigned to receive either effective tDCS targeting the left DLPFC or effective tDCS targeting the DMPFC. Primary outcome measures focus on changes in clinical symptom assessments.

Conditions

Depression

Keywords

depression; transcranial direct current stimulation; dorsolateral prefrontal cortex; dorsomedial prefrontal cortex

Outcome Measures

Primary Outcomes (2)

• 17-item Hamilton Depression Rating Scale (HAMD)

  Improvement in HAMD scores following transcranial direct current stimulation (tDCS) treatment (The HAMD consists of 17 items, with a total score ranging from 0 to 53; a higher score indicates more severe depressive symptoms).

  Baseline, immediately after all intervention, and follow-up after all intervention (1 month).

• Positive and Negative Affect Schedule (PANAS)

  The degree of improvement in PANAS scores following transcranial direct current stimulation (used to assess patients' positive and negative emotions; consisting of 20 items, with 10 items representing positive emotions; the total positive emotion score ranges from 0 to 50, with higher scores indicating greater vitality and enthusiasm; the other 10 items represent negative emotions, with the total negative emotion score ranging from 0 to 50; higher scores indicate stronger negative emotions).

  Baseline and immediately after all intervention.

Secondary Outcomes (6)

• Self-Rating Depression Scale (SDS)

  Baseline and immediately after all intervention.

• Hamilton Anxiety Rating Scale (HAMA)

  Baseline and immediately after all intervention.

• 15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-15)

  Baseline and immediately after all intervention.

• Insomnia Severity Index (ISI)

  Baseline and immediately after all intervention.

• Ruminative Responses Scale (RRS)

  Baseline and immediately after all intervention.

Study Arms (2)

DLPFC group

ACTIVE COMPARATOR

Participants will receive 10 sessions of transcranial direct current stimulation (tDCS) treatment over 5 days, with stimulation targeting the dorsolateral prefrontal cortex (DLPFC).

Device: transcranial direct current stimulation (tDCS)

DMPFC group

ACTIVE COMPARATOR

Participants will receive 10 sessions of transcranial direct current stimulation (tDCS) treatment over 5 days, with stimulation targeting the dorsomedial prefrontal cortex (DMPFC).

Device: transcranial direct current stimulation (tDCS)

Interventions

transcranial direct current stimulation (tDCS) DEVICE

Stimulation was delivered using a high-precision transcranial direct current stimulation (tDCS) device (Soterix Medical, Inc., New York, USA) via five small electrode pads (1 cm × 1 cm) arranged in a 4×1 ring configuration.

DLPFC group; DMPFC group

Eligibility Criteria

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

You may qualify if:

• The diagnosis meets the criteria for depression outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
• Age between 18 and 65 years.
• Education level exceeding 5 years, with no significant hearing or visual impairments.
• Voluntary signing of informed consent and ability to cooperate with general demographic data collection and neuropsychological scale testing.

You may not qualify if:

• Age under 18 or over 65.
• Patients with neurological disorders such as epilepsy or severe physical illnesses.
• Patients with comorbid neuropsychiatric disorders, such as schizophrenia or obsessive-compulsive disorder.
• Patients unable to undergo tDCS treatment for any reason, including presence of ferromagnetic metal in the head or implanted medical devices in the head/neck region.
• Pregnant or lactating women.

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

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

Central Study Contacts

Yanghua Tian

CONTACT

+86-13955188448; tianyh@ahmu.edu.cn

Study Design

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

Model Details: Stimulation was delivered using a high-precision transcranial direct current stimulation (tDCS) device (Soterix Medical, Inc., New York, USA) via five small electrode pads (1 cm × 1 cm) arranged in a 4×1 ring configuration. Following the international 10/20 EEG system: For the dorsolateral prefrontal cortex (DLPFC) group, the anode centered at F3 received 100% of the 2 mA current, while the cathode received 25% of the current via four peripheral electrodes at Fp1, F7, C3, and Fz. For the dorsomedial prefrontal cortex (DMPFC) group, the anode centered at Fz received 100% of the 2 mA current, while the cathode centered at Fz received 25% of the current via four peripheral electrodes at Fpz, F3, Cz, and F4. Participating patients with depression were randomly assigned to receive either active tDCS targeting the left DLPFC or active tDCS targeting the DMPFC. Both groups received tDCS treatment twice daily for 5 days, with each session lasting 20 minutes at 2 mA.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: March 30, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)