UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024216
Receipt number R000027849
Scientific Title The efficacy of repeated transcranial magnetic stimulation on communication and skilled motor function of children
Date of disclosure of the study information 2016/11/01
Last modified on 2018/04/10 14:17:13

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Basic information

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

Condition

autism spectrum disorder

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

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


Base

Study type

Interventional


Study design

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


Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

Japan Science AND Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

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

Other related information



Management 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