臨床研究等提出・公開システム

Specified Clinical Trial for efficacy and safety of rTMS for neurodevelopmental disorder

rTMS therapy for neurodevelopmental disorder

Shimono Kuriko

The University of Osaka Hospital

Osaka Suita Yamadaoka 2-15

shimono.kuriko.ugscd@osaka-u.ac.jp

Iwatani Yoshiko

The University of Osaka Hospital

Osaka Suita Yamadaoka 2-15

+81-6-6879-5111

handai.kokoro@gmail.com

Not Recruiting

Sept. 01, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. patients with a diagnosis of Autism Spectrum Disorder (ASD) made by a pediatrician or psychiatrist using the DSM-5 (The Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders). Manual of Mental Disorders) by a pediatrician or psychiatrist.
2. have no organic abnormalities on MRI within 2 years prior to rTMS and have not previously been found to have epilepsy or afebrile seizures
3. Patients must have an intellectual quotient (IQ) of 60 or higher
4. right-handed diagnosed by the Edinburgh Handedness Inventory.
5. who are of age 8 to 30 years at the time of consent.
6. have been fully informed of the study and have provided informed consent from their parents or guardians and written assent from the patients themselves.

1. those with metal present in the head other than the mouth.
2. those with a history of cardiac disease, gastrointestinal disease, chronic kidney disease, head trauma, or brain tumor.
3. those who have received a cardiac pacemaker, deep brain electrical stimulator, spinal cord stimulator, or drug therapy pump implantation.
4. those who have an organic abnormality in the cranium.
4. those with intracranial organic abnormalities (due to increased risk of seizure induction)
5. who have a history of convulsive disorders (febrile convulsions, epileptic seizures, epilepsy)
6. pregnant woman
7. who are deemed inappropriate by the responsible or subcontracting physician.

Both

Neurodevelopmental disorder

repetitive transcranial magnetic stimulation Once per day, twice per week, 8 weeks

Neurodevelopmental Disorder

transcranial magnetic stimulation

D065886

D050781

1) Number of cases which completed the treatment protocol
2) Number, frequency and severity of adverse events

1) Change from baseline in questionnaire scores of sensory abnormality and social responsiveness
2) APD test score

+81-6-6210-8270

Aug. 21, 2025

none