Back to resultsNear-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
Primary Purpose
Neurofeedback, Attention Deficit Hyperactivity Disorder (ADHD)
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
NIRS neurofeedback
Methylphenidate or Tomoxetine
Sponsored by
About this trial
This is an interventional treatment trial for Neurofeedback focused on measuring NIRS, fNIRS, neurofeedback, attention deficit hyperactivity disorder (ADHD), children
Eligibility 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
Sites / Locations
- Department of Psychiatry, Xijing Hospital, The Air Force Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
Other
Arm Label
NIRS group
Drug group
Control group
Arm Description
Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week.
Children with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine
Healthy children, 12 sessions of NIRS feedback, for two sessions per week.
Outcomes
Primary Outcome Measures
Change in SNAP-IV
Change in SNAP-IV(Swanson, Nolan, and Pelham-IV rating scales) score between groups over time
Secondary Outcome Measures
Change in CGI
Change in CGI (Clinical Global Impression Scale) score between groups over time
Change in PSQ
Change in PSQ(Parent Symptom Questionnaire) score between groups over time
Change in TRS
Change in TRS (Conners' Teacher Rating Scale, TRS )score between groups over time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04065906
Brief Title
Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
Official Title
Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofeedback, Attention Deficit Hyperactivity Disorder (ADHD)
Keywords
NIRS, fNIRS, neurofeedback, attention deficit hyperactivity disorder (ADHD), children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
NIRS group
Arm Type
Experimental
Arm Description
Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week.
Arm Title
Drug group
Arm Type
Other
Arm Description
Children with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine
Arm Title
Control group
Arm Type
Other
Arm Description
Healthy children, 12 sessions of NIRS feedback, for two sessions per week.
Intervention Type
Behavioral
Intervention Name(s)
NIRS neurofeedback
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate or Tomoxetine
Intervention Description
Methylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD
Primary Outcome Measure Information:
Title
Change in SNAP-IV
Description
Change in SNAP-IV(Swanson, Nolan, and Pelham-IV rating scales) score between groups over time
Time Frame
Baseline, week 3, week 6, week 8
Secondary Outcome Measure Information:
Title
Change in CGI
Description
Change in CGI (Clinical Global Impression Scale) score between groups over time
Time Frame
Baseline, week 3, week 6, week 8
Title
Change in PSQ
Description
Change in PSQ(Parent Symptom Questionnaire) score between groups over time
Time Frame
Baseline, week 3, week 6, week 8
Title
Change in TRS
Description
Change in TRS (Conners' Teacher Rating Scale, TRS )score between groups over time
Time Frame
Baseline, week 3, week 6, week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjun Wu, master
Phone
+86 02984771141
Email
wenjun104@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huaning Wang, doctor
Phone
+86 02984771141
Email
xskzhu@fmmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenjun Wu, master
Organizational Affiliation
Xijing Hospital, The Air Force Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Huaning Wang, doctor
Organizational Affiliation
Xijing Hospital, The Air Force Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi Zhang, professor
Organizational Affiliation
Xidian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Xijing Hospital, The Air Force Medical University
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjun Wu, master
Phone
+86 02984771141
Email
wenjun104@126.com
First Name & Middle Initial & Last Name & Degree
Huaning Wang, doctor
Phone
+86 02984771141
Email
xskzhu@fmmu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22146580
Citation
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.
Results Reference
result
PubMed Identifier
25928870
Citation
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.
Results Reference
result
PubMed Identifier
27238063
Citation
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.
Results Reference
result
PubMed Identifier
30096196
Citation
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.
Results Reference
result
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Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
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