Accelerated Intermittent Theta Burst Stimulation for Depressed Patients During the Covid-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Remission of depressive symptoms using the Hamilton Depression Rating Scale (HAM - D or HDRS) - 17 version
研究概览
简要总结
Repetitive Transcranial Magnetic Stimulation (rTMS) using intermittent theta burst stimulation (iTBS) has been found to be a non inferior protocol to standard rTMS for the treatment of major depressive disorder. An accelerated course is of particular interest given the safety profile of the procedure and the potential to treat people more quickly making the treatment more accessible. This study aims to assess the feasibility and clinical outcomes of a high dose iTBS protocol in patients with depression in the context of unipolar or bipolar II disorder who are waiting for Electroconvulsive therapy (ECT) or rTMS due to degree of treatment resistance or severity of symptoms. This is a prospective, open-label, interventional pilot study wherein patients who have been diagnosed with major depressive disorder and referred to brain stimulation clinic, will be recruited for the treatment. Patients will be administered eight questionnaires before and after the treatment to assess the change in clinical outcomes.
详细描述
Participants will receive same stimulation protocol, however they will be given 6 times per day instead of once per day. Each Treatment will consist of a single iTBS treatment delivering 600 puses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duy cycle of 2 seconds on, 8 seconds off, over 60 cycles and it takes about 3 minutes at a target of 90 to 120% of the subject's resting motor threshold. Treatment will be given through the device that is usually used, which is Magpro by Magventure, B70 Fluid-Cooled Coil .
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years and older
- •Unipolar Depression or Bipolar II depression based on the MINI - no psychotic features
- •Pass the TMS safety screen on the brain stimulation consultation template Voluntary and Competent to consent to treatment
排除标准
- •Have a MINI confirmed diagnosis of a substance use disorder within the last month
- •Have a concomitant major unstable medical illness, cardiac pacemaker or implanted mediation pump
- •Have a lifetime MINI diagnosis of bipolar I, or schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder.
- •Have any significant neurological disorder or insult including but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT, or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, or significant head trauma with loss of consciousness for greater than 5 minutes
- •Have an intracranial implant (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head (excluding the mouth) that cannot be safely removed.
- •Currently taking more than lorazepam 2mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy.
结局指标
主要结局
Remission of depressive symptoms using the Hamilton Depression Rating Scale (HAM - D or HDRS) - 17 version
时间窗: at screening (within a week of starting treatment) to a week post treatment
Severity of depressive symptoms being measured pre and post treatment - remission is less than 8 (low score is less depression, higher score - more depressive symptoms, range is 0 to 53)
次要结局
- Response to treatment with reduction of 50% in depressive symptoms on HAM-D - 17 and PHQ - 9 (patient health questionnaire)(at screening (within a week of starting treatment) to a week post treatment)
- Response of anxiety symptoms - reduction by 50% - Generalized Anxiety disorder scale (GAD-&)(at screening (within a week of starting treatment) to a week post treatment)
- Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire (QUAL-ES-Q)(at screening (within a week of starting treatment) to a week post treatment)
- Patient Health Questionnaire (PHQ-9) - Response to symptoms(at screening (within a week of starting treatment ) to a week post treatment)
- Change in World Health Organization Disability assessment scale (WHODAS)(at screening (within a week of starting treatment) to a week post treatment)
- Improvement overall using the Clinical Global Severity/Impression Scale (CGI-I)(at screening (within a week of starting treatment) to a week post treatment)
研究者
Dr. Robyn Waxman
Head of Brain Stimulation Clinic
Ontario Shores Centre for Mental Health Sciences