NCT06429748进行中（未招募）不适用
A Prospective Study to Evaluate Symptoms Following Repetitive Transcranial Magnetic Stimulation (rTMS)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Neuronetics
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes in multiple symptoms after rTMS treatment.
研究概览
简要总结
A prospective study to evaluate symptoms following repetitive transcranial Magnetic stimulation.
详细描述
Open-label, multicenter, prospective pilot study conducted in an adult population receiving rTMS treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults, 22 to 70 years of age
- •Voluntarily provides written informed consent and agree to comply with study procedures, including attending all study visits and completing all study assessments.
- •Score > or = 8 on ISI scale
- •If subject is on any psychiatric or sleep medication, dose must be stable for two weeks prior to enrollment and remain stable throughout the trial.
- •If female, not breastfeeding, no known or suspected pregnancy, a status of nonchildbearing potential or use of an acceptable form of birth control.
- •Subject on stable dose regime for other concurrent medications like hormonal therapy for menopause transition etc.
排除标准
- •Subject meets any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
- •History of head trauma associated with loss of consciousness or diagnosed as concussion.
- •History of fainting, syncope, hearing problems or ringing in the ears (tinnitus)
- •Has any metallic implant(s) in or near the head (e.g., pacemaker, defibrillator, neurostimulator, etc.) including any splinters, fragments, clips, etc.
- •Has an implanted stimulator device (including device leads) in or near the head. (e.g. deep brain stimulator, cochlear implant, vagus nerve stimulator.)
- •Has medication infusion device.
- •Subjects with any prior TMS or MRI complications, or any other issues/circumstance which, in the opinion of the investigator, might interfere with safety, study participation, or which might confound data interpretation.
- •PHQ-9 total score > or = 10 or QIDS total score > or =
- •Drug abuse or dependence of the illicit substance. (Abuse or Dependence, as defined by DSM-V-TR)
- •Current diagnosis or known history of neurologic disease (e.g., epilepsy, convulsion, seizure)
- •Other known disorder (e.g., narcolepsy, a breathing-related sleep disorder like Obstructive Sleep Apnea, a circadian rhythm sleep-wake disorder, a parasomnia) as defined by DSM-V-TR.
- •Has a clinically significant abnormality on the screening examination.
- •Participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.
研究组 & 干预措施
Open Label
Experimental
Single Group
干预措施: rTMS (Device)
结局指标
主要结局
Changes in multiple symptoms after rTMS treatment.
时间窗: 4 weeks
Assess changes in multiple symptoms scores based on patient reported questionnaires from baseline to end of acute.
次要结局
- Durability of changes in symptoms(16 weeks)
研究者
研究点 (2)
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