Intervention Effect of High Definition Transcranial Alternating Current Stimulation (HD-tACS) on Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale (HAMD) Score
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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≥
- •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.
排除标准
- •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
结局指标
主要结局
Change in Hamilton Depression Rating Scale (HAMD) Score
时间窗: baseline and immediately after the intervention
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.
Change in Beck Scale for Suicide Ideation (BSS) Score
时间窗: baseline and immediately after the intervention
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.
次要结局
- Change in Montreal Cognitive Assessment (MoCA) Score(baseline and immediately after the intervention)
- Change in the Montgomery-Asberg Depression Rating Scale (MADRS) Score(baseline and immediately after the intervention)
- Change in Hamilton Anxiety Scale (HAMA) Score(baseline and immediately after the intervention)
- Change in Beck Depression Inventory (BDI) Score(baseline and immediately after the intervention)
- Change in the Patient Health Questionnaire-15 (PHQ-15) scale(baseline and immediately after the intervention)
- Change in Auditory Verbal Learning Test (AVLT) Score(baseline and immediately after the intervention)
- EEG Measure of Frontal Alpha Asymmetry (FFA) Oscillations(baseline and immediately after the intervention)
- MRI measures of functional connectivity (FC)(baseline and immediately after the intervention)
研究者
WANG KAI
Director of medical psychological department, Anhui Medical University
Anhui Medical University