Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
NCT ID: NCT04065906
Last Updated: 2019-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2019-01-15
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NIRS group
Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week.
NIRS neurofeedback
Neurofeedback as a treatment for ADHD can be interpreted as a way to increase behavioral inhibition. A method to assess brain activity is functional near-infrared spectroscopy (NIRS), measuring hemodynamic correlates of neural activity.
Drug group
Children with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine
Methylphenidate or Tomoxetine
Methylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD
Control group
Healthy children, 12 sessions of NIRS feedback, for two sessions per week.
NIRS neurofeedback
Neurofeedback as a treatment for ADHD can be interpreted as a way to increase behavioral inhibition. A method to assess brain activity is functional near-infrared spectroscopy (NIRS), measuring hemodynamic correlates of neural activity.
Interventions
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NIRS neurofeedback
Neurofeedback as a treatment for ADHD can be interpreted as a way to increase behavioral inhibition. A method to assess brain activity is functional near-infrared spectroscopy (NIRS), measuring hemodynamic correlates of neural activity.
Methylphenidate or Tomoxetine
Methylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD
Eligibility Criteria
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Inclusion Criteria
* aged 6-12;
* right handed;
Exclusion Criteria
* medical or neurological disorders, psychiatric disorders other than oppositional defiant disorder
* current participation in a psychotherapeutic treatment
6 Years
12 Years
ALL
Yes
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Wu Wenjun-1
Department of Psychiatry, Xijing Hospital, The Air Force Medical University
Principal Investigators
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Wenjun Wu, master
Role: STUDY_CHAIR
Xijing Hospital, The Air Force Medical University
Huaning Wang, doctor
Role: PRINCIPAL_INVESTIGATOR
Xijing Hospital, The Air Force Medical University
Yi Zhang, professor
Role: PRINCIPAL_INVESTIGATOR
Xidian University
Locations
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Department of Psychiatry, Xijing Hospital, The Air Force Medical University
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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Inoue Y, Sakihara K, Gunji A, Ozawa H, Kimiya S, Shinoda H, Kaga M, Inagaki M. Reduced prefrontal hemodynamic response in children with ADHD during the Go/NoGo task: a NIRS study. Neuroreport. 2012 Jan 25;23(2):55-60. doi: 10.1097/WNR.0b013e32834e664c.
Mayer K, Wyckoff SN, Fallgatter AJ, Ehlis AC, Strehl U. Neurofeedback as a nonpharmacological treatment for adults with attention-deficit/hyperactivity disorder (ADHD): study protocol for a randomized controlled trial. Trials. 2015 Apr 18;16:174. doi: 10.1186/s13063-015-0683-4.
Cortese S, Ferrin M, Brandeis D, Holtmann M, Aggensteiner P, Daley D, Santosh P, Simonoff E, Stevenson J, Stringaris A, Sonuga-Barke EJ; European ADHD Guidelines Group (EAGG). Neurofeedback for Attention-Deficit/Hyperactivity Disorder: Meta-Analysis of Clinical and Neuropsychological Outcomes From Randomized Controlled Trials. J Am Acad Child Adolesc Psychiatry. 2016 Jun;55(6):444-55. doi: 10.1016/j.jaac.2016.03.007. Epub 2016 Apr 1.
Hudak J, Rosenbaum D, Barth B, Fallgatter AJ, Ehlis AC. Functionally disconnected: A look at how study design influences neurofeedback data and mechanisms in attention-deficit/hyperactivity disorder. PLoS One. 2018 Aug 10;13(8):e0200931. doi: 10.1371/journal.pone.0200931. eCollection 2018.
Other Identifiers
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KY20192044-F-1
Identifier Type: -
Identifier Source: org_study_id
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