A Prospective, Comparative Study to Explore the Efficacy and Safety of the Five Channels Multiway Deep Transcranial Magnetic Stimulation (TMS) Device in Subjects With Major Depression Disorder (MDD)
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clinical antidepressant response
研究概览
简要总结
The Multiway stimulator is a novel TMS stimulator with several new and unique properties. Currently standard TMS devices include a single channel, and can operate only a single coil. The Multiway stimulator includes five channels which can operate up to five independent TMS coils, either simultaneously or sequentially.
The Multiway device may be used to obtain a differential activation of various brain regions. For instance it can be used to induce high frequency stimulation of a certain brain region, thus inducing facilitation, while simultaneously stimulate at low frequency in another brain region, leading to inhibition.
The purpose of the study is to explore the efficacy and safety of Multiway deep TMS in comparison to a single channel DTMS treatment in subjects with MDD.
Subjects will be treated with one of two designs of the study device (the Multiway Coil TMS Device):
- Single Channel with a coil placed over the left PFC (10 Hz).
- Four channels: a. 10 Hz over the left PFC. b. 1 Hz over the right PFC. c. 10 Hz over the left parietal cortex. d. 1 Hz over the right parietal cortex.
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
- None
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatient
- •Diagnosed by senior psychiatrist as suffering from major depression episode according to DSM IV using the Structured Clinical Interview for DSM-4 (SCID).
- •Rating on HDRS-21>
- •Age: 18-68 years.
- •Treated for the current depressive episode, at least four weeks, with at least one antidepressant in accepted dose, without improvement, according to their medical chart and ATHF ( antidepressant treatment history form) instruction guidelines .
- •Gave informed consent for participation in the study.
- •Negative answers on safety screening questionnaire for transcranial magnetic stimulation.
排除标准
- •Diagnosis as suffering from other diagnosis on axis 1 ( like: schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
- •Diagnosis as suffering from Severe Borderline Personality Disorder or hospitalized due to exacerbation related to of borderline personality disorder.
- •Substantial suicidal risk as judged by the treating psychiatrist.
- •Attempted suicide in the past year.
- •Any current unstable medical or surgical illness.
- •History of seizure or heat convulsion.
- •History of epilepsy or seizure in first degree relatives.
- •History of head injury.
- •History of any metal in the head (outside the mouth).
- •Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips, cochlear implants or any medical pumps.
- •History of hearing loss.
- •History of drug abuse or alcoholism in the last 6 month.
- •Pregnancy or not using a reliable method of birth control.
- •Systematic and metabolic unstable disorders.
- •Inadequate communication with the patient.
- •Under custodial care.
- •Participation in current clinical study or clinical study within 30 days prior to this study.
研究组 & 干预措施
single channel
Single Channel with a coil placed over the left PFC (10 Hz).
干预措施: 5 channels Multiway deep Transcranial Magnetic Stimulator (Device)
four channels
Four channels:
- 10 Hz over the left PFC.
- 1 Hz over the right PFC.
- 10 Hz over the left parietal cortex.
- 1 Hz over the right parietal cortex.
干预措施: five channels Multiway deep Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Clinical antidepressant response
时间窗: day 20
Clinical antidepressant response at the end of the treatment, defined as a decline in Hamilton depression rating scale (HDRS-21) from the baseline rating by 50%.
次要结局
- Clinical antidepressant remission(day 20)
- Symptomatic improvement(day 20)