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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

Tracking Information
First Submitted Date  ICMJE August 20, 2019
First Posted Date  ICMJE August 22, 2019
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE January 15, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • Change in CGI [ Time Frame: Baseline, week 3, week 6, week 8 ]
    Change in CGI (Clinical Global Impression Scale) score between groups over time
  • Change in PSQ [ Time Frame: Baseline, week 3, week 6, week 8 ]
    Change in PSQ(Parent Symptom Questionnaire) score between groups over time
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
Official Title  ICMJE Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
Brief Summary To observe the clinical efficacy and mechanism of functional near-infrared spectroscopy imaging neurofeedback therapy for attention deficit and hyperactivity disorder.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neurofeedback
  • Attention Deficit Hyperactivity Disorder (ADHD)
Intervention  ICMJE
  • 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: Methylphenidate or Tomoxetine
    Methylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD
Study Arms  ICMJE
  • Experimental: NIRS group
    Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week.
    Intervention: Behavioral: NIRS neurofeedback
  • Drug group
    Children with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine
    Intervention: Drug: Methylphenidate or Tomoxetine
  • Control group
    Healthy children, 12 sessions of NIRS feedback, for two sessions per week.
    Intervention: Behavioral: NIRS neurofeedback
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Wenjun Wu, master +86 02984771141 wenjun104@126.com
Contact: Huaning Wang, doctor +86 02984771141 xskzhu@fmmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04065906
Other Study ID Numbers  ICMJE KY20192044-F-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wu Wenjun-1, Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Xijing Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP