Safety and Efficacy of an Accelerated, Rectangular Waveform rTMS Protocol in Treatment of Adults With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Montgomery-Åsberg Depression Rating Scale (MADRS) Score
研究概览
简要总结
Transcranial Magnetic Stimulation (TMS) Therapy is a non-invasive procedure that uses magnetic pulses to stimulate the cortex (brain) to treat Major Depressive Disorder (MDD). Currently established therapy uses one 19-minute treatment session per day for 5 days per week for 6 weeks, for a total of 30 treatment sessions.
The goal of this clinical trial is to evaluate the safety and effectiveness of an accelerated but shortened TMS dosing regimen for adults with MDD aged 22-85.
Participants in this study will be subjected to the same 19-minutes treatment session, but three times on the same day, and only for one day. This will greatly reduce the logistical burden of completing the therapy regime.
详细描述
Study Description:
This single center, open label study will evaluate the safety and efficacy of accelerating the delivery of the NeuroQore TMS system's rectangular waveform rTMS protocol for the treatment of adults with MDD aged 22-85.
Currently cleared protocol with the FDA (the Standard of Care Protocol) is one 19-min treatment session a day for 5 days/week for 6 weeks. The accelerated protocol will involve the same 19-min treatment session offered three times in a single day, with no additional treatment sessions.
Primary Objectives:
- To assess the efficacy of the NeuroQore TMS system, with accelerated delivery in the treatment of adults with MDD, as measured by a change in MADRS score 24 hours and 7 days after the treatment end.
- To compare the safety profile of the accelerated delivery protocol to the historical safety profile of the Standard of Care protocol.
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
- 22 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 22-
- •Current diagnosis of major depressive disorder according to the criteria defined in the current Diagnosis and Statistical Manual of Mental Disorders (DSM-V) without psychotic features.
- •Failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
- •MADRS score > 20 at baseline and immediately prior to the day of treatment.
- •Agrees to adhere to the study treatment and follow-up schedule.
- •Willingness to remain on stable medications during rTMS therapy.
- •Fluent in English.
排除标准
- •Any medical conditions that would preclude the use of rTMS to treat depression.
- •Any conditions that would prevent the ability to undergo MRI testing.
- •Pregnancy as determined by serum/urine pregnancy test
- •History of epilepsy, seizure(s), or a seizure disorder as determined by the principal investigator based on a medical history obtained from the patient and/or others authorized to provide such history, combined with a brief screening instrument.
- •Active substance abuse
- •Diagnosis of bipolar or psychotic disorder
- •Considered to be at moderate-high risk of suicide according to the CSSRS assessment (i.e., Answers YES to Question 3 and NO to Question 6; or answers YES to Question 4, 5, or 6)
- •As determined by the Principal Investigator, subjects with cognitive impairment according to either the medical history obtained from the patient and/or a reliable secondary source, or the results of the Montreal Cognitive Assessment (MoCA) performed during screening.
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale (MADRS) Score
时间窗: From enrollment to final MADRS score assessment within 2 weeks.
Change in MADRS score from baseline to immediately post treatment, 24 hours and 7 days post-treatment
次要结局
- Patient Health Questionnaire-9 (PHQ-9) Score(From enrollment to final PHQ-9 score assessment within 2 weeks.)