A Block-Randomized Study Comparing Deep and Standard Prolonged Intermittent Theta Burst Stimulation on Emotional Symptoms and Physiological Indicators in Patients With Major Depression
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D17) Score
研究概览
简要总结
This study compares two types of non-invasive brain stimulation to treat major depression in patients who have not found relief from at least one antidepressant medication.
The study will use a specific type of brain stimulation called prolonged intermittent Theta Burst Stimulation (piTBS). The standard way to use piTBS for depression is to target an area on the side of the head called the dorsolateral prefrontal cortex (DLPFC). This study will compare this standard piTBS method with a newer approach, deep piTBS, which targets a different, deeper area in the middle of the brain called the anterior cingulate cortex (ACC).
Participants will be randomly assigned to one of two groups. One group will receive the deep piTBS treatment, and the other will receive the standard piTBS treatment. Both treatments are given once a day, five days a week, for four weeks. The study aims to find out if the deep piTBS approach is more effective at reducing symptoms of depression than the standard approach. Researchers will also look at effects on anxiety and other related symptoms.
详细描述
Background:
Major depressive disorder (MDD) is associated with dysfunction in large-scale brain networks, including the central executive network (CEN), default mode network (DMN), and the salience network (SN). The anterior cingulate cortex (ACC) is a key hub in the SN, and its dysfunction is believed to be a core pathological feature of depression. While high-frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) is an evidence-based treatment for treatment-resistant depression (TRD), it only indirectly modulates deeper structures like the ACC. Deep TMS techniques using a double-cone coil can directly stimulate deeper regions such as the medial prefrontal cortex (mPFC) and ACC, which may offer a more direct and potentially more effective therapeutic approach. Intermittent theta burst stimulation (iTBS) is a newer form of rTMS that significantly shortens treatment time, but its application to deep brain targets like the ACC has not been well-studied.
Objective:
This study aims to compare the therapeutic efficacy of prolonged intermittent theta burst stimulation (piTBS) targeting the ACC (deep piTBS) versus the standard protocol targeting the left DLPFC (standard piTBS) for patients with TRD. The study will also evaluate the effects of these interventions on comorbid anxiety, obsessive-compulsive, and somatic symptoms, as well as on physiological indicators.
Study Design:
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
- Single (Outcomes Assessor)
盲法说明
The raters for the primary and key secondary outcome scales (including HAM-D17, HAM-A, YMRS, and Y-BOCS) are blinded to the participant's treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages between 18 and 70 years, inclusive.
- •Diagnosis of Major Depressive Disorder (MDD) with a current major depressive episode, according to DSM-5 criteria, as confirmed by a psychiatrist.
- •History of inadequate response to at least one trial of an antidepressant medication of adequate dose and duration.
- •A score of 18 or greater on the 17-item Hamilton Depression Rating Scale (HAM-D17) at the screening visit.
排除标准
- •Lifetime diagnosis of any primary psychotic disorder (e.g., schizophrenia spectrum disorders) or bipolar and related disorders according to DSM-
- •Significant current suicide risk, as indicated by a score of 4 on item 3 of the HAM-D
- •Current substance use disorder (excluding tobacco) within the last 3 months, according to DSM-
- •Presence of significant cognitive impairment, such as intellectual disability, delirium, or a diagnosed neurocognitive disorder.
- •Any personal history of seizures, stroke, brain tumor, brain aneurysm, increased intracranial pressure, or other major neurological disorders.
- •Presence of metal implants in the head (excluding dental fillings) or any implanted medical devices such as a cardiac pacemaker or defibrillator.
- •Currently pregnant.
- •Any other major medical condition that, in the investigator's judgment, could compromise participant safety or interfere with the study procedures.
研究组 & 干预措施
Deep piTBS
Participants assigned to the experimental group receive prolonged intermittent theta burst stimulation (piTBS) with a double-cone coil targeting the anterior cingulate cortex (ACC).
干预措施: Deep Prolonged Intermittent Theta Burst Stimulation (Device)
Standard piTBS
Participants assigned to the active comparator group receive prolonged intermittent theta burst stimulation (piTBS) with a planar coil targeting the left dorsolateral prefrontal cortex (DLPFC).
干预措施: Standard Prolonged Intermittent Theta Burst Stimulation (Device)
结局指标
主要结局
Change From Baseline in the 17-item Hamilton Depression Rating Scale (HAM-D17) Score
时间窗: Baseline (Day 1, prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.
The 17-item Hamilton Depression Rating Scale (HAM-D17) is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is derived from a structured interview conducted by a trained outcomes assessor who is blinded to the participant's treatment group. Scores range from 0-52, where higher scores indicate more severe depression.
次要结局
- Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A) Score(Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.)
- Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Score(Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.)
- Change From Baseline in the Beck Depression Inventory-II (BDI-II) Score(Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.)
- Change From Baseline in the Beck Anxiety Inventory (BAI) Score(Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.)
- Change From Baseline in the Young Mania Rating Scale (YMRS) Score(Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.)
- Change From Baseline in the Patient Health Questionnaire-15 (PHQ-15) Score(Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.)
- Change From Baseline in the Health Anxiety Questionnaire (HAQ) Score(Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.)
- Change From Baseline in Heart Rate Variability (HRV) Indices(Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.)
- Change From Baseline in Skin Conductance(Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.)
- Change From Baseline in Respiratory Sinus Arrhythmia (RSA)(Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.)
- Change From Baseline in Finger Temperature(Baseline (prior to first treatment), after 5 treatments (Week 1), after 10 treatments (Week 2), after 15 treatments (Week 3), after 20 treatments (End of Week 4), and at a 1-week follow-up after the final treatment session.)