Intervention Effect of High Definition Transcranial Alternating Current Stimulation (HD-tACS) on Depressive Disorder
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Transcranial Alternating Current Stimulation
- 发起方
- Anhui Medical University
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Rating Scale (HAMD) Score
- 状态
- 已完成
- 最后更新
- 3个月前
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.
研究者
WANG KAI
Director of medical psychological department, Anhui Medical University
Anhui Medical University
入排标准
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)