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

未提供0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年4月21日

适应症

试验速览

暂无简介。

•Autism Spectrum Disorder(ASD): Patients diagnosed by semi-structured interview and psychiatric examination using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-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
•Age: 18<=and<40
•Gender: both
•Patients with written consent of this clinical study

•Full IQ < 70(WAIS-IV)
•Patients with suicidal ideation and suicide attempts within the last year
•Drug or alcohol abuse
•Pregnant women
•Serious physical illness
•Personality disorder
•A history of epileptic / convulsive seizures or their comorbidities
•Taking drugs that lower the seizure threshold (tricyclic antidepressants, maprotiline, theophylline, methylphenidate, ketamine, clozapine, zotepine, etc.)
•Organic brain dysfunction and lesions
•Cardiac pacemaker
•Internal metal objects near the stimulation site(cochlear implants, magnetic clips, deep brain stimulator, vagus nerve stimulator)
•Patients who are disqualified as participants by the investigator or sub-investigator

ITI total score(PTSD assessment section)

时间窗: baseline(visit1) to the next week(visit13) post-intervention

Change from baseline(visit1) to the next week(visit13) post-intervention

Change in ITI total score(PTSD assessment section)(baseline(visit1), 1 month(visit14), 2 month(visit15))
Change in ITI subscale(PTSD assessment section)(baseline(visit1), visit13, visit14, visit15)
Change in ITI total score and subscale(CPTSD assessment section)(baseline(visit1), visit13, visit14, visit15)
Change in IES-R total score and subscale(baseline(visit1), visit13, visit14, visit15)
Change in BDI-II score(baseline(visit2), visit13, visit14, visit15)
Change in WHOQOL26 score(baseline(visit2), visit13, visit14, visit15)
Responder rate(baseline(visit1), visit13, visit14, visit15)

发起方

未提供