Efficacy of rTMS for the communication and motor ability

Not Applicable

• Conditions: Autism spectrum disorder

• Registration Number: JPRN-jRCTs052180067
• Lead Sponsor: Taniike Masako

Brief Summary

This study was conducted on patients with autism spectrum disorder (ASD) using repetitive transcranial magnetic stimulation (rTMS). Its efficacy and safety were evaluated in a single-blind before/after comparison using sham stimulation. The fine motor function and gross motor performance with coordinated movements showed mild improvement only when the right primary motor and right dorsal premotor were stimulated. No apparent adverse events were observed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-19
• Study Completion: 2022-10-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 3

Inclusion Criteria

1. Boys who were diagnosed as autism spectrum disorder in the clinic of developmental disorders in Osaka University Hospital. The diagnosis was made by specialists in child neurology or psychiatry according to the DSM-V (The Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders), ADI-R (Autism Diagnostic Interview, Revised) which is a specific interview form to the parent with ASD, or AODS (Autism Diagnostic Observation Schedule) which is a specific observation tool for autism diagnosis.
2. Children in whom organic brain abnormality or epileptic abnormality were denied by MRI and EEG examination performed less than two and one year prior to rTMS, respectively.
3. Children with IQ more than 80.
4. Right-handed children judged by Edinburgh Handedness Inventory.
5. Children with age of 10 to 15 years when consent are obtained. 6. Children who obtained written informed consent after the detailed explanation.

Exclusion Criteria

1. Those who suffer from physical comorbid disorders except developmental disorders.
2. Those who have any instrument including metal in the head except oral cavity.
3. Those who have a history of heart, gastrointestinal, chronic renal diseases, head trauma or brain tumors.
4. Those who were instrumented with a cardiac pacemaker, a deep brain or a spinal stimulation or drug-delivery pump.
5. Those who possess intracranial organic lesions and at increased risk for induction of convulsion.
6. Those who have a history of convulsive diseases including febrile seizures, epileptic seizures or epilepsy.
7. Those who take medicine that decrease the convulsive threshold such as anti-depressant, anti-psycotic or anti-histamine drugs.
8. Those who is judged to be not suitable for participating in the study by responsible or contributing doctors.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Outcome for efficacy (evaluated on the day when rTMS is performed) <br> a. coordinated upper limb movement evaluated by Trace Coder <br> b. Motor evoked potential (MEP)<br> c. Sociocognitive function evaluated by GazeFinder <br>2. Outcome for safety <br> the occurrence of adverse events and their extent

Secondary Outcome Measures

Name	Time	Method
1. Outcome for efficacy (evaluated on the day when rTMS is performed) <br> Global motor function evaluated by Movement Assessment Battery<br> for Children 2 (M-ABC2) <br>2. Outcome for saftey <br> The occurrence of severe adverse events at each site of<br> stimulation