NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs052220170

Registered date:15/02/2023

EMAT Study

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedAutism spectrum disorder
Date of first enrollment15/02/2023
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)Repetitive transcranial magnetic stimulation

Outcome(s)

Primary OutcomeChange from baseline(visit1) to the next week(visit13) post-intervention in ITI total score(PTSD assessment section)
Secondary Outcome1) Change from baseline(visit1) to 1 month(visit14) and 2 month(visit15) post-intervention in ITI total score(PTSD assessment section) 2) Change from baseline(visit1) to each assessment time(visit13,14,15) in ITI subscale(PTSD assessment section) 3) Change from baseline(visit1) to each assessment time(visit13, 14, 15) in ITI total score and subscale(CPTSD assessment section) 4) Change from baseline(visit1) to each assessment time(visit13, 14, 15) in IES-R total score and subscale 5) Change from baseline(visit2) to each assessment time(visit13, 14, 15) in BDI-II score 6) Change from baseline(visit2) to each assessment time(visit13, 14, 15) in WHOQOL26 score 7) Responder rate: responder defined as the percentage of participants who met the criteria from baseline (visit1) to each assessment time (visits13, 14, 15) with a total score improvement of at least 30% in ITI (Parts 1 and 2) or IES-R

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum< 40age old
GenderBoth
Include criteria1) 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
Exclude criteria1) 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

Related Information

Contact

Public contact
Name Daisuke Ikawa
Address 840 Shijo-Cho, Kashihara, Nara,Japan Nara Japan 634-8522
Telephone +81-744223051
E-mail navi@naramed-u.ac.jp
Affiliation Nara Medical University Hospital
Scientific contact
Name Daisuke Ikawa
Address 840 Shijo-Cho, Kashihara, Nara,Japan Nara Japan 634-8522
Telephone +81-744223051
E-mail navi@naramed-u.ac.jp
Affiliation Nara Medical University Hospital