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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
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.
Yanghua Tian
Hefei, Anhui, China
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.
Time frame: baseline, week 1 (end of treatment), and week 5 (end of follow-up)
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.
Time frame: 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).
Time frame: 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.
Time frame: baseline, week 1 (end of treatment), and week 5 (end of follow-up)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and week 1 (end of treatment)