Feasibility Pilot of Accelerated Stimulation With TMS for Treatment of Major Depressive Disorder (FAST-MDD)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Reduction in depressive symptoms
研究概览
简要总结
This is a mixed-methods study that includes three steps. The first is a focus group to collect opinions and feedback about implementation of aTMS among clinicians, technicians, nurses, and other clinical staff at the St. Louis Park (SLP) clinic who are experienced with delivering TMS. The second is the delivery of a set of questionnaires delivered to TMS patients at the SLP clinic who are awaiting the start of their TMS series. The third is the delivery of aTMS utilizing the MagVenture TMS device to patients on the SLP rTMS waitlist.
The purpose of this feasibility study is to examine the acceptability and efficacy of Accelerated Transcranial Magnetic Stimulation (aTMS) delivered using an accelerated schedule. Repetitive Transcranial Magnetic Stimulation (rTMS) is traditionally delivered once a day, five days a week, for nearly 7 weeks for a total of 36 treatments. While aTMS is quick to deliver, a standard session lasting 10-20 minutes, this schedule is time intensive for patients. It often requires time off from work to accommodate daily driving time to and from the clinic as well as treatment time. This can be disruptive to a patients life and ability to attend all treatment sessions while continuing with their own life responsibilities.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years old
- •Current patient of SLP Clinic
- •Diagnosis of Unipolar Depression
- •Have tried at least 1 antidepressant
- •Ability to maintain stable medication regimen for duration of study
排除标准
- •Has received TMS in the last 3 months
- •Diagnosis of Bipolar Depression
- •Any lifetime psychosis or mania
- •Recent suicide attempt within 90 days of study visit
- •Use of Benzodiazepines in past 4 weeks
- •Presence of any contraindication to TMS assessed by the TMS Adult Safety Screen including individual history of uncontrolled seizures
- •Current or history of alcohol abuse
研究组 & 干预措施
Study group
Patients with major depressive disorder
干预措施: aTMS utilizing the MagVenture TMS device (Other)
结局指标
主要结局
Reduction in depressive symptoms
时间窗: baseline and 6 weeks
assessed via the PHQ9, comparing baseline to end of treatment and 6 weeks post treatment.
次要结局
- Durability data of aTMS(0, 1, 2, 4, and 6 weeks post treatment)
- Dropout rate(6 weeks)
