JRCT ID: jRCTs052220170
Registered date:15/02/2023
EMAT Study
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Autism spectrum disorder |
Date of first enrollment | 15/02/2023 |
Target sample size | 30 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Repetitive transcranial magnetic stimulation |
Outcome(s)
Primary Outcome | Change from baseline(visit1) to the next week(visit13) post-intervention in ITI total score(PTSD assessment section) |
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Secondary Outcome | 1) 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 |
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Age maximum | < 40age old |
Gender | Both |
Include criteria | 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 |
Exclude criteria | 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 |
Related Information
Primary Sponsor | Ikawa Daisuke |
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Secondary Sponsor | |
Source(s) of Monetary Support | Nara Medical University,Japan Society for the Promotion of Science |
Secondary ID(s) |
Contact
Public contact | |
Name | Daisuke Ikawa |
Address | 840 Shijo-Cho, Kashihara, Nara,Japan Nara Japan 634-8522 |
Telephone | +81-744223051 |
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 |
navi@naramed-u.ac.jp | |
Affiliation | Nara Medical University Hospital |