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NCT Number: NCT07500064

Transcranial Direct Current Stimulation for Depression

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location status: Recruiting

Location contact

Nanxue Duan

CONTACT

[email protected]

+86-18326962052

About this study

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 different affective regulation networks, this study aims to investigate the differential effects of tDCS targeting these regions on emotional regulation in patients with depression.

Design:

This study employed a randomized, double-blind, controlled design. Inpatients with depression were recruited from the Department of Psychology and Sleep Medicine at the Second Affiliated Hospital of Anhui Medical University. Participants were randomly assigned to receive either effective tDCS targeting the left DLPFC or effective tDCS targeting the DMPFC. Both groups will receive tDCS treatment twice daily for 5 consecutive days. Each session lasts 20 minutes at 2mA, with a minimum 4-hour interval between sessions. Before the start of tDCS treatment and after completion of all sessions, clinical psychologists conducted standardized assessments and collected EEG data from the patients. Assessments included tests of associative memory, the Self-Rating Depression Scale (SDS), the 17-item Hamilton Depression Rating Scale (HAMD), Hamilton Anxiety Rating Scale (HAMA), 15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-15), PHQ-15), the Insomnia Severity Index (ISI), the Positive and Negative Affect Scale (PANAS), and the Ruminative Responses Scale (RRS). Follow-up was conducted after one month, during which only the HAMD scale was assessed. Primary clinical outcomes included changes in HAMD scores at baseline, post-treatment, and 1-month follow-up; number of responders and remitters post-treatment (response defined as >50% reduction in HAMD score at endpoint; remission defined as HAMD score ≤7 at endpoint); improvement in PANAS scores post-treatment; correlation between HAMD improvement and PANAS improvement. Secondary outcomes included changes in residual scale scores post-treatment, changes in EEG signals in stimulated brain regions, and changes in functional connectivity across the entire brain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 17-item Hamilton Depression Rating Scale (HAMD)

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

    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).

  2. Positive and Negative Affect Schedule (PANAS)

    Time frame: Baseline and immediately after all intervention.

    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).

Secondary outcomes

  1. Self-Rating Depression Scale (SDS)

    Time frame: Baseline and immediately after all intervention.

    Improvement in SDS (SDS comprises 20 items with a total score range of 0-100; higher scores indicate more severe depressive symptoms) scores following transcranial direct current stimulation treatment.

  2. Hamilton Anxiety Rating Scale (HAMA)

    Time frame: Baseline and immediately after all intervention.

    Improvement in HAMA (HAMA comprises 14 items with a total score range of 0-56; higher scores indicate more severe anxiety symptoms) scores following transcranial direct current stimulation treatment.

  3. 15-item Somatic Symptom Severity Scale of the Patient Health Questionnaire (PHQ-15)

    Time frame: Baseline and immediately after all intervention.

    Improvement in PHQ-15(comprising 15 items with a total score of 30; higher scores indicate more severe somatization symptoms) scores following transcranial direct current stimulation treatment.

  4. Insomnia Severity Index (ISI)

    Time frame: Baseline and immediately after all intervention.

    Improvement in ISI(comprising 7 items with a total score of 28; higher scores indicate more severe insomnia) scores following transcranial direct current stimulation treatment.

  5. Ruminative Responses Scale (RRS)

    Time frame: Baseline and immediately after all intervention.

    Improvement in RRS (comprising 22 items with a total score of 88; higher scores indicate more severe rumination tendencies) scores following transcranial direct current stimulation treatment.

  6. EEG measurements

    Time frame: Baseline and immediately after all intervention.

    Changes in EEG signal metrics in the stimulated target brain regions and in functional connectivity with the entire brain.

Study contacts

Contact information is provided by the study sponsor or research team.

Yanghua Tian

CONTACT

[email protected]

+86-13955188448

Sponsors and collaborators

Lead sponsor

The Second Hospital of Anhui Medical University

Other

Registry information

Official study title

A Comparative Study of the Clinical Efficacy of Transcranial Direct Current Stimulation Targeting the DLPFC Versus DMPFC in the Treatment of Depression

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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