Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Methylphenidate or Tomoxetine
- Conditions
- Neurofeedback
- Sponsor
- Xijing Hospital
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Change in SNAP-IV
- Last Updated
- 6 years ago
Overview
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.
Investigators
Wu Wenjun-1
Department of Psychiatry, Xijing Hospital, The Air Force Medical University
Xijing Hospital
Eligibility Criteria
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
Arms & Interventions
Drug group
Children with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine
Intervention: Methylphenidate or Tomoxetine
NIRS group
Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week.
Intervention: NIRS neurofeedback
Control group
Healthy children, 12 sessions of NIRS feedback, for two sessions per week.
Intervention: NIRS neurofeedback
Outcomes
Primary Outcomes
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 Outcomes
- Change in TRS(Baseline, week 3, week 6, week 8)
- Change in CGI(Baseline, week 3, week 6, week 8)
- Change in PSQ(Baseline, week 3, week 6, week 8)