JPRN-jRCTs052220170已完成2 期
The Effect of repetitive transcranial Magnetic stimulation on patients with Autism spectrum disorder and Traumatic symptoms:a double-blind, randomized, sham-controlled Phase II study
Ikawa Daisuke0 个研究点目标入组 30 人开始时间: 2023年2月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 < 40age old（—）
- 性别
- All
入选标准
- •1) Autism Spectrum Disorder(ASD): Patients diagnosed by semi-structured interview and psychiatric examination using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
- •2) Patients with trauma symptoms: Not necessarily required to have experienced severe life-threatening trauma
- •International Trauma Interview (ITI) Part 1>=6 points and Revised Event Impact Scale Japanese version (IES-R)>=25 points.
- •*ITI Part 1 PTSD Assessment Section, Part 2 Complex PTSD(CPTSD) Assessment Section
- •3) Age: 18<=and<40
- •4) Gender: both
- •5) Patients with written consent of this clinical study
排除标准
- •1) Full IQ < 70(WAIS-IV)
- •2) Patients with suicidal ideation and suicide attempts within the last year
- •3) Drug or alcohol abuse
- •4) Pregnant women
- •5) Serious physical illness
- •6) Personality disorder
- •7) A history of epileptic / convulsive seizures or their comorbidities
- •8) Taking drugs that lower the seizure threshold (tricyclic antidepressants, maprotiline, theophylline, methylphenidate, ketamine, clozapine, zotepine, etc.)
- •9) Organic brain dysfunction and lesions
- •10) Cardiac pacemaker
- •11) Internal metal objects near the stimulation site(cochlear implants, magnetic clips, deep brain stimulator, vagus nerve stimulator)
- •12) Patients who are disqualified as participants by the investigator or sub-investigator
研究者
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