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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| real stimulation | Active Comparator | 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. |
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| sham stimulation | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanghua Tian, PhD | Anhui Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yanghua Tian | Hefei | Anhui | 230022 | China |
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| 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. |
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| 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) |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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