A Prospective, Randomized, Single Blind, Crossover Study to Evaluate Treatment Effects Associated With the NeuroStar New Treatment Feature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Neuronetics
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluate Comfort of TMS Treatment
研究概览
简要总结
The purpose of this study is to evaluate the comfort of the NeuroStar® Advanced Therapy System regular prescribed TMS protocol versus a New Feature.
详细描述
This is a 2 week study to evaluate the New Feature an exclusive feature available on the NeuroStar® Advanced Therapy System. This feature introduces a series of stepped pulses within each pulse train ramping up the pulse magnitude to the prescribed treatment level. Patients will be randomized after consent to receive either the standard Dash protocol or the modified Dash protocol with the New feature enabled. The subjects will be switched between treatment protocols and asked to complete comfort, and depression questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The study will be randomized to avoid any bias in treatment arm assignment. Subjects will be blinded to the actual treatment arm throughout the study to allow patient to provide an honest assessment of the treatment they are receiving daily. Subjects will not be informed of the treatment at the end of their study participation.
入排标准
- 年龄范围
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22-70 years.
- •Subject qualifies to receive TMS Therapy with the NeuroStar Advanced Therapy System to treat Major Depressive Disorder (MDD) per current FDA-cleared treatment guidelines as evaluated by the treating physician.
- •Subject has MDD diagnosis according to applicable DSM-IV, DSM-IV-TR, DSM-V, ICD-9, or ICD-10 criteria.
- •Subject failed to respond to at least one prior anti-depressant medication.
- •Subject consented to receive TMS Therapy to treat MDD with his or her physician independent of potential participation in this clinical study.
- •Subject must agree not to take analgesic pain medication(s) within 8 hours prior to TMS therapy sessions.
- •Subject provides written consent to take part in the study.
排除标准
- •Subject satisfies any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
- •Physician intends to treat the subject with an off-label TMS Therapy or indication.
- •Family history of seizures or epilepsy.
- •Subject has received prior TMS.
- •Subject is currently taking analgesic medication or substances which may affect their perception or sensation of pain.
- •Known or suspected pregnancy.
结局指标
主要结局
Evaluate Comfort of TMS Treatment
时间窗: 10 days
The average Visual Analog Scale scores for the two conditions Dash protocol and modified DASH. VAS - Visual Analog Scale range is 0-100 (0- no pain/discomfort; 100- extreme discomfort/worse pain)
次要结局
- Time to Reach Prescribed Treatment Intensity(5 days)