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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014036
Receipt No. R000016345
Scientific Title Neurophysiological analysis of ADHD: an exploratory neuroimaging study using functional near-infrared spectroscopy (fNIRS)
Date of disclosure of the study information 2014/06/01
Last modified on 2014/05/22

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Basic information
Public title Neurophysiological analysis of ADHD: an exploratory neuroimaging study using functional near-infrared spectroscopy (fNIRS)
Acronym Clinically-oriented monitoring of acute effects of Atomoxetine (ATX) on cerebral hemodynamics in ADHD children: an exploratory fNIRS study using a target detection task
Scientific Title Neurophysiological analysis of ADHD: an exploratory neuroimaging study using functional near-infrared spectroscopy (fNIRS)
Scientific Title:Acronym Clinically-oriented monitoring of acute effects of Atomoxetine (ATX) on cerebral hemodynamics in ADHD children: an exploratory fNIRS study using a target detection task
Region
Japan

Condition
Condition Attention deficit hyperactivity disorder
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to confirm the
localiization attention in ADHD children during a target detection task with using fNIRS.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes (1) fNIRS analysis
Comparison of frontal activation (oxy-Hb, deoxy-Hb and total-Hb, measured by fNIRS) before and after an acute clinical dose of ATX or placebo (90 min after ATX administration)

(2) Behavioral performance
Comparison of reaction time and percentage of correct response on target detection task before and after the acute clinical dose of ATX or placebo (90 min after ATX administration)
Key secondary outcomes The response of continuous administration of ATX on ADHD rating scale and Questionnaire-Children with Difficulties

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 washout (more than 2 days) - ATX (1 day)
Interventions/Control_2 washout (more than 2 days) - placebo (1 day)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
6 years-old <=
Age-upper limit
16 years-old >=
Gender Male and Female
Key inclusion criteria All subjects meet the following criteria.

(1) Subjects are under 16 years old and more than 6 years old. Regardless of sex and treatment before this trial.

(2) Subjects are diagnosed with ADHD based on DSM-IV or V through an interview with more than two pediatric neurologists.

(3) Written informed consent was obtained from the parents of all subjects, and the study was approved by the Ethics Committee of Jichi Medical University Hospital, Japan.

(4) The Wechsler Intelligence Scale of Children-Third Edition (WISC-III or IV) full IQ scores of subjects are over 70
Key exclusion criteria (1) Subjects who are diagnosed with anxiety disorder

(2) Subjects who are diagnosed with glaucoma

(3) Subjects who are diagnosed with hyperthyroidism

(4) Subjects who have angina, arrhythmia

(5) Subjects who have allergies to ATX

(6) Subjects who are diagnosed with tics or Tourette's syndrome, or have family history of Tourette's syndrome

(7) Subjects who are diagnosed with severe depression

(8) Subjects who are diagnosed with pheochromocytoma

(9) Subjects who current or past use of monoamine oxidase inhibitor (MAOI)
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiju Watanabe
Organization Jichi Medical University
Division name Neurosurgery
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL 0285-58-7373
Email eiju@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiju Watanabe
Organization Jichi Medical University
Division name Neurosurgery
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
TEL 0285-58-7373
Homepage URL
Email eiju@jichi.ac.jp

Sponsor
Institute Department of Neurosurgery, Jichi Medical University Hospital
Institute
Department

Funding Source
Organization Comprehensive Research on Disability,
Health and Welfare from Health and Labour Sciences Research Grants
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor International University of Health and Welfare Hospital
Name of secondary funder(s) International University of Health and Welfare

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 とちぎ子ども医療センター(栃木県)

Other administrative information
Date of disclosure of the study information
2014 Year 06 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
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2014 Year 08 Month 30 Day
Date of closure to data entry
2014 Year 10 Month 01 Day
Date trial data considered complete
2014 Year 10 Month 01 Day
Date analysis concluded
2014 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 05 Month 22 Day
Last modified on
2014 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016345

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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