UMIN-CTR Clinical Trial

Public title

The efficacy of repeated transcranial magnetic stimulation on communication and skilled motor function of children

Acronym

The efficacy of repeated transcranial magnetic stimulation on communication and skilled motor function of children

Scientific Title

The efficacy of repeated transcranial magnetic stimulation on communication and skilled motor function of children

Scientific Title:Acronym

The efficacy of repeated transcranial magnetic stimulation on communication and skilled motor function of children

Region

Japan

Condition

autism spectrum disorder

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safety and the effect of repeated transcranial magnetic stimulation (rTMS) on social and motor function of children with autism spectrum disorder

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

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
c. Sociocognitive function evaluated by GazeFinder
2. Outcome for safety
a. the occurrence of adverse events and their extent

Key secondary outcomes

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

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization

No. of arms

5

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

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)

Interventions/Control_2

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.
2. right dorsal premotor area, 3. right ventral premotor area, 1. right primary motor area, 5. right primary motor area (sham stimulation), 4. right cerebellar hemisphere

Interventions/Control_3

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, 4. right cerebellar hemisphere, 5. right primary motor area (sham stimulation), 2. right dorsal premotor area, 3. right ventral premotor area,

Interventions/Control_4

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.
3. right ventral premotor area, 2. right dorsal premotor area, 5. right primary motor area (sham stimulation), 1. right primary motor area, 4. right cerebellar hemisphere

Interventions/Control_5

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.
2. right dorsal premotor area, 1. right primary motor area, 4. right cerebellar hemisphere, 5. right primary motor area (sham stimulation), 3. right ventral premotor area

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

10

years-old

<=

Age-upper limit

15

years-old

>=

Gender

Male

Key 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. Written informed consent should be obtained after the detailed explanation.

Key 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.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Masako Taniike

Organization

Osaka University Hospital

Division name

Pediatrics

Zip code

Address

2-2 Yamadaoka, Suita

TEL

06-6879-3863

Email

masako@kokoro.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kuriko Shimono

Organization

Osaka University Hospital

Division name

Pediatrics

Zip code

Address

2-2 Yamadaoka, Suita

TEL

06-6879-3863

Homepage URL

Email

kuriko@ped.med.osaka-u.ac.jp

Institute

Osaka University

Institute

Department

Personal name

Organization

Japan Science AND Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2016

Year

10

Month

01

Day

Date of IRB

Anticipated trial start date

2017

Year

03

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

09

Month

29

Day

Last modified on

2018

Year

04

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027849