Unique ID issued by UMIN | UMIN000014036 |
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Receipt number | 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 12:24:47 |
Neurophysiological analysis of ADHD: an exploratory neuroimaging study using functional near-infrared spectroscopy (fNIRS)
Clinically-oriented monitoring of acute effects of Atomoxetine (ATX) on cerebral hemodynamics in ADHD children: an exploratory fNIRS study using a target detection task
Neurophysiological analysis of ADHD: an exploratory neuroimaging study using functional near-infrared spectroscopy (fNIRS)
Clinically-oriented monitoring of acute effects of Atomoxetine (ATX) on cerebral hemodynamics in ADHD children: an exploratory fNIRS study using a target detection task
Japan |
Attention deficit hyperactivity disorder
Pediatrics |
Others
NO
The aim of the study is to confirm the
localiization attention in ADHD children during a target detection task with using fNIRS.
Efficacy
Confirmatory
Pragmatic
Not applicable
(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)
The response of continuous administration of ATX on ADHD rating scale and Questionnaire-Children with Difficulties
Interventional
Cross-over
Randomized
Cluster
Double blind -all involved are blinded
Placebo
NO
NO
NO
No need to know
2
Diagnosis
Medicine | Device,equipment |
washout (more than 2 days) - ATX (1 day)
washout (more than 2 days) - placebo (1 day)
6 | years-old | <= |
16 | years-old | >= |
Male and Female
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
(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)
18
1st name | |
Middle name | |
Last name | Eiju Watanabe |
Jichi Medical University
Neurosurgery
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
0285-58-7373
eiju@jichi.ac.jp
1st name | |
Middle name | |
Last name | Eiju Watanabe |
Jichi Medical University
Neurosurgery
3311-1 Yakushiji, Shimotsuke, Tochigi, Japan
0285-58-7373
eiju@jichi.ac.jp
Department of Neurosurgery, Jichi Medical University Hospital
Comprehensive Research on Disability,
Health and Welfare from Health and Labour Sciences Research Grants
Japan
International University of Health and Welfare Hospital
International University of Health and Welfare
NO
とちぎ子ども医療センター(栃木県)
2014 | Year | 06 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2014 | Year | 03 | Month | 01 | Day |
2014 | Year | 04 | Month | 01 | Day |
2014 | Year | 08 | Month | 30 | Day |
2014 | Year | 10 | Month | 01 | Day |
2014 | Year | 10 | Month | 01 | Day |
2014 | Year | 10 | Month | 01 | Day |
2014 | Year | 05 | Month | 22 | Day |
2014 | Year | 05 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016345
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