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).

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Transcranial Alternating Current Stimulation
• Intervention / Treatment: Device: High definition transcranial alternating current stimulation; Device: sham high definition transcranial alternating current stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Yanghua Tian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: real stimulation; The central electrode was placed over F3, with return electrodes 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 IAF.	Device: High definition transcranial alternating current stimulation; 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 Comparator: sham stimulation; In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (15 and 15 s); no current was delivered during the 30-minute intervention. Participants will receive sham tACS twice daily for two weeks.	Device: sham high definition transcranial alternating current stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Beck Scale for Suicide Ideation (BSS) Score	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.	baseline, week 1 (end of treatment), and week 5 (end of follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Scale for Suicide Ideation (BSS) Response Rate (≥50% Improvement From Baseline)	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.	week 1 (end of treatment) and week 5 (end of follow-up)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Score	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).	baseline, week 1 (end of treatment), and week 5 (end of follow-up)
Change in Hamilton Depression Rating Scale (HAMD) Score	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.	baseline, week 1 (end of treatment), and week 5 (end of follow-up)
Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score	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.	baseline, week 1 (end of treatment), and week 5 (end of follow-up)
Change in Beck Depression Inventory (BDI) Score	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.	baseline, week 1 (end of treatment), and week 5 (end of follow-up)
Change in Hamilton Anxiety Scale (HAMA) Score	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.	baseline, week 1 (end of treatment), and week 5 (end of follow-up)
Change in Game of Dice Task (GDT) Score	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.	baseline and week 1 (end of treatment)
EEG Measure of Frontal Alpha Asymmetry (FFA) Oscillations	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.	baseline and week 1 (end of treatment)
MRI measures of functional connectivity (FC)	the functional connectivity between stimulated target and the whole brain areas; the global and regional activity measures.	baseline and week 1 (end of treatment)

Collaborators and Investigators

• Sponsor: Anhui Medical University
• Investigators: Study Chair: Yanghua Tian, PhD, Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 17, 2026
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder
• Other Study ID Numbers: AHMU-tACS-MDD

Drug and device information, study documents

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