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
- Enrolling By Invitation
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- 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 multi-site sham-controlled double-blinded randomized clinical trial is to evaluate the safety and effectiveness of accelerating the delivery of the NeuroQore Square TMS system's rectangular waveform rTMS protocol for the treatment of adults aged 22-85 with Major Depressive Disorder.
The accelerated protocol of this study will involve the same currently FDA-cleared 19-min treatment session offered three times in a single day, with no additional treatment sessions.
详细描述
Study Description:
This multi-site sham-controlled double-blinded randomized study will evaluate the safety and efficacy of accelerating the delivery of the NeuroQore Square TMS system's rectangular waveform rTMS protocol for the treatment of adults aged 22-85 with Major Depressive Disorder.
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 Square TMS system, with accelerated delivery, in the treatment of adults with major depressive disorder as measured by a change in MADRS score 24 hours, 7 days and 30 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Device operators delivering the treatment regimen are also masked.
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. The diagnosis of DSM-5 criteria-defined MDD will be made by a psychiatrist in light of a comprehensive psychiatric evaluation and other available clinical data.
- •Drug-resistant MDD (lack of improvement on antidepressant medication in the current episode, despite adequate dose and duration and adherence to treatment).
- •MADRS score > 20 at baseline and immediately prior to the day of treatment.
- •Agrees to adhere to the study treatment and follow-up schedule.
- •Evidence of no change in AD medications or psychotherapy from 4 weeks prior to enrollment and participant's agreement not to request such changes through 2 weeks after study regimen treatment.
- •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 C-SSRS 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.
研究组 & 干预措施
Active Accelerated Protocol
Three 19-min TMS treatment protocol delivered on the same day, with 1 hour rest between the sessions.
干预措施: Active Accelerated rTMS Treatment (Device)
Sham Accelerated Protocol
Three 19-min TMS treatment protocol simulated but blocked from delivery to the target region in Cortex, on the same day, with 1 hour rest between the sessions.
干预措施: Sham Accelerated rTMS Treatment (Device)
结局指标
主要结局
MADRS Score
时间窗: From enrollment to final MADRS score assessment within 6 weeks.
Change in MADRS score from baseline to immediately post treatment, 24 hours, 7 days and 30 days post-treatment.
次要结局
- PHQ-9 Score(From enrollment to final PHQ-9 score assessment within 6 weeks.)