Using Multiple Brain-based Biomarkers to Validate and Predict Response to Theta Burst Stimulation as a New Treatment for Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale
研究概览
简要总结
This study investigates the brain-based biomarkers of treatment response to accelerated theta burst stimulation (aTBS) in patients with Major Depressive Disorder resistant to pharmacological treatment(MDD) in an open label design.
详细描述
Theta burst stimulation (TBS) is a newer form of rTMS which requires less stimulation time and produces longer lasting post-stimulation effects in the cerebral cortex (4). It has been shown to be effective in inducing synaptic plasticity and has similar or better efficacy in treating depression compared to rTMS (4).Newer accelerated TBS (aTBS) protocols that condense stimulation sessions down to several days rather than weeks have shown similar response rates when compared to prolonged TBS protocols, also with similar tolerability and safety. In order to develop aTBS as an effective treatment for MDD, future research should focus on identification of reliable predictors for better outcome to TBS. The main objectives were: 1) To directly compare multiple different brain-based measures (neuroimaging and electrophysiology) to identify which has the most power in accurately predicting response to TBS compared to sham. 2) To track both short and long-term longitudinal electrophysiological (EEG) changes related to the therapeutic effects of TBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participant must meet the DSM-5 diagnostic criteria for single-episode Major Depressive Disorder (MDD).
- •Participant must have failed to respond to >1 but <4 classes of oral antidepressant treatments in the current episode of depression.
- •Participant must have a HAMD total score of at least 18
排除标准
- •The participant's depressive symptoms have previously demonstrated nonresponse to:
- •An adequate course of rTMS/TBS over DLPFC in the current major depressive episode, defined as at least 3 weeks of treatment, 5 times weekly
- •An adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral/bilateral ECT.
- •Participant has received vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression.
- •Participant has a current or prior DSM-5 diagnosis of Axis I comorbidities, including psychosis, bipolar disorder, obsessive compulsive disorder, based upon clinical assessment and confirmed by the MINI.
- •Participant has a current or prior DSM-5 diagnosis of Axis II comorbidities, including severe borderline personality disorders, antisocial, schizotypal, schizoid personality disorders based upon clinical assessment and confirmed by the MINI.
- •Participant has severe suicidal ideation/plan/ intent.
- •Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria.
- •Participant has a current or past history of seizures and neurological problems, e.g. head injury, stroke, progressive neurological disorder and complicated and unstable medical disorders, e.g. cardiovascular-related conditions, diabetes.
研究组 & 干预措施
Active TBS-DLPFC
There is only one arm. All participants will receive Theta Burst Stimulation (transcranial magnetic stimulation) of the dorsolateral prefrontal cortex.
干预措施: Theta Burst Stimulation ( Transcranial Magnetic Stimulation) (Device)
结局指标
主要结局
Hamilton Depression Rating Scale
时间窗: Change from baseline at 5 days of TBS treatment
Clinician administered questionnaire to asses clinical improvement and classify response and remission
次要结局
- Global Assessment of Functioning (GAF)(Change from baseline at 5 days of TBS treatment)
- Resting state functional connectivity-Functional magnetic resonance imaging (rsfMRI)(Pretreatment baseline)
- 1. Montgomery-Åsberg Depression Rating Scale (MADRS)(Change from baseline at 5 days of TBS treatment)
- MGH Rumination questionnaire(Change from baseline at 5 days of TBS treatment)
- Snaith-Hamilton Pleasure scale-Clinician administered (SHAP-C)(Change from baseline at 5 days of TBS treatment)
- 36 item short form survey (SF-36)(Change from baseline at 5 days of TBS treatment)
- Magnetic resonance spectroscopy (MRS)(Pretreatment baseline)
- Electroencephalogram(Change from baseline at 5 days of TBS treatment)
- 2. Hamilton Anxiety rating Scale (HAM-A)(Change from baseline at 5 days of TBS treatment)
- 2. Columbia Suicide Severity Rating Scale ( CSSRS)(Change from baseline at 5 days of TBS treatment)
研究者
Rajamannar Ramasubbu
Professor
University of Calgary