Autism spectrum disorder
Conditions
Interventions
Repetitive transcranial magnetic stimulation
Sponsors
Ikawa Daisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline(visit1) to the next week(visit13) post-intervention in ITI total score(PTSD assessment section) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactDaisuke Ikawa
Nara Medical University Hospital
Outcome results
None listed