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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

EMAT Study

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Patients with Autism spectrum disorder and Traumatic symptoms

A Sham-controlled, double-blind, randomized, sham-controlled phase II study to evaluate the effict of transcranial magnetic stimulation on patients with autistic spectrum disorder and traumatic symptoms. Before the recruitment of participants.

none

No data were obtained.

This study was terminated prior to participant recruitment.

April. 21, 2024

No

No plan

https://jrct.mhlw.go.jp/latest-detail/jRCTs052220170

Ikawa Daisuke

Nara Medical University Hospital

840 Shijo-Cho, Kashihara, Nara,Japan

navi@naramed-u.ac.jp

Ikawa Daisuke

Nara Medical University Hospital

840 Shijo-Cho, Kashihara, Nara,Japan

+81-744223051

navi@naramed-u.ac.jp

Complete

Feb. 15, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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

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

Both

Autism spectrum disorder

Repetitive transcranial magnetic stimulation

Change from baseline(visit1) to the next week(visit13) post-intervention in ITI total score(PTSD assessment section)

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

+81-744298835

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