Efficacy of rTMS for the communication and motor ability

JRCT ID: jRCTs052180067

Registered date:19/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Autism spectrum disorder
• Date of first enrollment: 21/07/2017
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Repeated transcranial magnetic stimulation (rTMS) with intensity of 90% of resting motor threshold and 900 pulses for one session was given to the following brain regions in the following order at the low frequency (1 Hz). Regarding the right cerebellar hemisphere, rTMS was administered at a fixed level of 55% of maximum stimulator output. Washout period of more than 13 days are set between each session.
1. right primary motor area, 2. right dorsal premotor area, 3. right ventral premotor area, 4. right cerebellar hemisphere, 5. right primary motor area (sham stimulation)

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 10age old
• Age maximum: <= 15age old
• Gender: Male

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Taniike Masako
• Source(s) of Monetary Support: Research grants from the Ministry of Education, Culture, Sports, Science and Technology of Japan
• Secondary ID(s): UMIN000024216