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Completed

NCT Number: NCT05932706

Intervention Effect of High Definition Transcranial Alternating Current Stimulation (HD-tACS) on Depressive Disorder

To investigate the intervention effect of high definition transcranial alternating current stimulation (HD-tACS) on suicidal ideation in patients with depressive disorder and its underlying neural mechanism by magnetic resonance imaging (MRI) and electroencephalography (EEG).

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Key information

Conditions

Transcranial Alternating Current Stimulation Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yanghua Tian

Hefei, Anhui, 230022, China

About this study

Forty patients with depressive disorder diagnosed by DSM-5 were recruited from the Anhui Mental Health Center and the first affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving high definition transcranial alternating current stimulation (HD-tACS) treatment after meeting the inclusion criteria and obtaining informed consent. Each participant will complete the clinical evaluation, magnetic resonance imaging (MRI), electroencephalography (EEG), and HD-tACS treatment conducted by trained researchers at the Anhui Mental Health Center. All the participants were randomized (1:1) to receive an "active HD-tACS" or "sham HD-tACS" treatment protocol. tACS: the central electrode was placed over F3 with return electrodes placed at Fp1, Fz, F7 and C3. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 15 and 15 seconds, respectively) were applied for 30 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as individual alpha frequency (IAF). Sham HD-tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 15 and 15 seconds.

Before and after the treatments, the patients received a battery measure of neuropsychological tests, resting EEG, and MRI scans in multimodalities. The neuropsychological assessment included HAMD, MADRS, BDI, HAMA, BSS, C-SSRS, PHQ15, RRS, TEPS, PVAQ, MoCA, Stroop Test, VFT, DST, and AVLT. Multimodal MRI includes 3D-T1, rs-fMRI, and DTI. The symptoms of the patients were followed up one and two months after the end of treatments.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for depression, and item 3 of the HAMD≥3.
  • the age ranged from 18 to 65 years old, and the length of education was more than 5 years.
  • the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.

Exclusion criteria

  • accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.
  • accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women.
  • accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective

Treatment and study plan

high definition transcranial alternating current stimulation

Device

tACS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.

sham high definition transcranial alternating current stimulation

Device

In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (15s and 15s); no current was delivered during the 30-minute intervention.

Primary outcomes

  1. Change in Beck Scale for Suicide Ideation (BSS) Score

    Time frame: baseline, week 1 (end of treatment), and week 5 (end of follow-up)

    The BSS is a 19-item scale to measure the severity of suicidal ideation, where each item is rated on a scale from 0 to 2. The BSS total score ranges from 0 to 38 with lower scores indicating less suicidal ideation.

Secondary outcomes

  1. Beck Scale for Suicide Ideation (BSS) Response Rate (≥50% Improvement From Baseline)

    Time frame: week 1 (end of treatment) and week 5 (end of follow-up)

    The BSS is a self-report measure of suicidal ideation severity, with higher scores indicating greater severity. Response was defined a priori as a 50% or greater reduction in BSS total score from baseline. The BSS response rate was calculated as the proportion of participants meeting this criterion at each postbaseline assessment.

  2. Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score

    Time frame: baseline, week 1 (end of treatment), and week 5 (end of follow-up)

    The C-SSRS is a clinician-administered instrument used to assess the severity of suicidal ideation and suicidal behavior. The suicidal ideation module evaluates (1) ideation severity over the past month (rated 1-5, with 0 indicating no suicidal ideation) and (2) ideation intensity across 5 items (eg, frequency and duration), each rated 0-5, yielding a total intensity score ranging from 0 to 25; higher scores indicate more severe suicidal ideation. The suicidal behavior module captures the presence and characteristics of suicidal behaviors (eg, number of attempts and lethality).

  3. Change in Hamilton Depression Rating Scale (HAMD) Score

    Time frame: baseline, week 1 (end of treatment), and week 5 (end of follow-up)

    The HAMD is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.

  4. Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score

    Time frame: baseline, week 1 (end of treatment), and week 5 (end of follow-up)

    The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60, with lower scores indicating less depressive symptoms.

  5. Change in Beck Depression Inventory (BDI) Score

    Time frame: baseline, week 1 (end of treatment), and week 5 (end of follow-up)

    The BDI is a 13-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 3. The BDI total score ranges from 0 to 39, with lower scores indicating less depressive symptoms.

  6. Change in Hamilton Anxiety Scale (HAMA) Score

    Time frame: baseline, week 1 (end of treatment), and week 5 (end of follow-up)

    The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.

  7. Change in Game of Dice Task (GDT) Score

    Time frame: baseline and week 1 (end of treatment)

    The GDT is a computerized task assessing risk decision-making under explicit probabilities. Participants choose between higher-risk options with lower winning probabilities (<50%) and higher safe options with winning probabilities (≥50%) across 18 trials; outcomes (gains/losses) are presented after each trial. Prespecified outcomes included the number of risky choices, number of safe choices, and a net score (safe choices minus risky choices), with higher net scores indicating safer decision-making.

  8. EEG Measure of Frontal Alpha Asymmetry (FFA) Oscillations

    Time frame: baseline and week 1 (end of treatment)

    EEG recordings were obtained from each subject based on 64 electrode locations of the International 10-20 system (sampling frequency 1000Hz). The change in FFA (8-13 Hz electrical activity) over time was measured.

  9. MRI measures of functional connectivity (FC)

    Time frame: baseline and week 1 (end of treatment)

    the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2023
Registry last updated
Jan 21, 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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