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

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

Detailed Description
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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.

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

Conditions
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Neurofeedback, Attention Deficit Hyperactivity Disorder (ADHD)

Intervention / Treatment
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* Behavioral: NIRS neurofeedback
* Drug: Methylphenidate or Tomoxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIRS group<br>Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week. | Behavioral: NIRS neurofeedback<br>* 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.<br>|
| Other: Drug group<br>Children with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine | Drug: Methylphenidate or Tomoxetine<br>* Methylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD<br>|
| Other: Control group<br>Healthy children, 12 sessions of NIRS feedback, for two sessions per week. | Behavioral: NIRS neurofeedback<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SNAP-IV | Change in SNAP-IV(Swanson, Nolan, and Pelham-IV rating scales) score between groups over time | Baseline, week 3, week 6, week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CGI | Change in CGI (Clinical Global Impression Scale) score between groups over time | Baseline, week 3, week 6, week 8 | 
| Change in PSQ | Change in PSQ(Parent Symptom Questionnaire) score between groups over time | Baseline, week 3, week 6, week 8 | 
| Change in TRS | Change in TRS (Conners' Teacher Rating Scale, TRS )score between groups over time | Baseline, week 3, week 6, week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NIRS, fNIRS, neurofeedback, attention deficit hyperactivity disorder (ADHD), children