NCT06214871招募中不适用
A Prospective Study To Evaluate Safety and Effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) For Neuroenhancement
Gerrish MedEsthetics2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Sleep Quality - Jenkins Sleep Scale
研究概览
简要总结
The purpose of this pilot study is to evaluate the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Sleep Quality, Mood and Memory.
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
- 是
入选标准
- •Male or female, 22 to 70 years of age
- •Freely provides written informed consent
- •In good general health, as ascertained by medical history
- •If female, not breastfeeding, no known or suspected pregnancy, a status of non- childbearing potential or use of an acceptable form of birth control
- •If subject is in menopausal transition, the subject must be stabilized on hormonal treatment.
- •Subject scored a 2 or higher on PHQ-9 sleep related question (#3), OR subject scored 2 or more on at least 2 QIDS-SR sleep related questions (#'s 1-4)
- •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.
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.
- •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 which, in the opinion of the investigator, might interfere with safety, study participation, or which might confound data interpretation,
- •Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by DSM-IV-TR), with the exception of nicotine dependence.
- •Current diagnosis or known history of neurologic or neuropsychiatric disease (e.g., epilepsy, convulsion, seizure)
- •Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results.
- •Participation in any clinical trial with an investigational drug or device within the past month or concurrent with study participation.
结局指标
主要结局
Sleep Quality - Jenkins Sleep Scale
时间窗: Various - Over 8 weeks
Jenkins Sleep Scale (Score can be from 0-20; higher scores equal lesser sleep quality)
Sleep Quality - PHQ-9 (Patient Health Questionnaire-9)
时间窗: Various - Over 8 Weeks
PHQ-9 (Question #3 score can be 0-3; higher score equal lesser sleep quality)
Sleep Quality - QIDS-SR (Quick Inventory of Depressive Symptomatology - Self Report)
时间窗: Various - Over 8 Weeks
QIDS-SR (Questions #1-#4 each question can be 0-3; higher score equals lesser sleep quality)
次要结局
- Memory - RAVLT Delayed Recall(Various - Over 8 weeks)
- Mood - PANAS (Positive and Negative Affect Schedule)(Various - Over 8 weeks)
- Memory - RAVLT Immediate Recall (Rey Auditory Verbal Learning Test)(Various - Over 8 weeks)
- Mood - VAMS (Visual Analog Mood Scale)(Various - Over 8 Weeks)
- Mood - SAMMS (Sleep, Anxiety, Mood, Memory Survey)(Various - Over 8 Weeks)
研究者
研究点 (2)
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