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Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT04065906
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Wu Wenjun-1, Xijing Hospital

Brief Summary:
To observe the clinical efficacy and mechanism of functional near-infrared spectroscopy imaging neurofeedback therapy for attention deficit and hyperactivity disorder.

Condition or disease Intervention/treatment Phase
Neurofeedback Attention Deficit Hyperactivity Disorder (ADHD) Behavioral: NIRS neurofeedback Drug: Methylphenidate or Tomoxetine Not Applicable

Detailed Description:
In this study, a parallel controlled study will be conducted to recruit 60 patients with ADHD, 30 patients in the fNIRS group and 30 patients in the drug group. At the same time, 30 healthy controls will be recruited. 6 weeks, 12 sessions of NIRS feedback will be given for participants in NIRS group and healthy controls. 6 weeks of first or second line medication will be given for participants of drug group. Magnetic resonance imaging will be performed at baseline for all participants. SNAP IV, PSQ, CGI will be evaluated at baseline, week 3, week 6 and week 8 for ADHD participants.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020


Arm Intervention/treatment
Experimental: NIRS group
Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week.
Behavioral: 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
Drug: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in SNAP-IV [ Time Frame: Baseline, week 3, week 6, week 8 ]
    Change in SNAP-IV(Swanson, Nolan, and Pelham-IV rating scales) score between groups over time


Secondary Outcome Measures :
  1. Change in CGI [ Time Frame: Baseline, week 3, week 6, week 8 ]
    Change in CGI (Clinical Global Impression Scale) score between groups over time

  2. Change in PSQ [ Time Frame: Baseline, week 3, week 6, week 8 ]
    Change in PSQ(Parent Symptom Questionnaire) score between groups over time

  3. Change in TRS [ Time Frame: Baseline, week 3, week 6, week 8 ]
    Change in TRS (Conners' Teacher Rating Scale, TRS )score between groups over time



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

For ADHD patients:

Inclusion Criteria:

  • diagnosed with TD, according to the American Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5);
  • aged 6-12;
  • right handed;

Exclusion Criteria:

  • full-scale intelligence quotient below 80(measured by Wechsler Intelligence Scale for Children,WISC)
  • medical or neurological disorders, psychiatric disorders other than oppositional defiant disorder
  • current participation in a psychotherapeutic treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065906


Contacts
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Contact: Wenjun Wu, master +86 02984771141 wenjun104@126.com
Contact: Huaning Wang, doctor +86 02984771141 xskzhu@fmmu.edu.cn

Locations
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China, Shaanxi
Department of Psychiatry, Xijing Hospital, The Air Force Medical University Recruiting
Xi'an, Shaanxi, China
Contact: Wenjun Wu, master    +86 02984771141    wenjun104@126.com   
Contact: Huaning Wang, doctor    +86 02984771141    xskzhu@fmmu.edu.cn   
Sponsors and Collaborators
Xijing Hospital
Investigators
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Study Chair: Wenjun Wu, master Xijing Hospital, The Air Force Medical University
Principal Investigator: Huaning Wang, doctor Xijing Hospital, The Air Force Medical University
Principal Investigator: Yi Zhang, professor Xidian University
Publications of Results:
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Responsible Party: Wu Wenjun-1, Department of Psychiatry, Xijing Hospital, The Air Force Medical University, Xijing Hospital
ClinicalTrials.gov Identifier: NCT04065906    
Other Study ID Numbers: KY20192044-F-1
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Wu Wenjun-1, Xijing Hospital:
NIRS
fNIRS
neurofeedback
attention deficit hyperactivity disorder (ADHD)
children
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Atomoxetine Hydrochloride
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents