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

Not Applicable

• Conditions: Neurofeedback; Attention Deficit Hyperactivity Disorder (ADHD)
• Interventions: Drug: Methylphenidate or Tomoxetine; Behavioral: NIRS neurofeedback

• Registration Number: NCT04065906
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-01-15
• Status Verified: 2019-08
• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-20
• Last Update Submitted: 2019-08-20
• Study First Posted: 2019-08-22
• Last Update Posted: 2019-08-22
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug group	Methylphenidate or Tomoxetine	Children with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine
NIRS group	NIRS neurofeedback	Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week.
Control group	NIRS neurofeedback	Healthy children, 12 sessions of NIRS feedback, for two sessions per week.

Primary Outcome Measures

Name	Time	Method
Change in SNAP-IV	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

Name	Time	Method
Change in CGI	Baseline, week 3, week 6, week 8	Change in CGI (Clinical Global Impression Scale) score between groups over time
Change in PSQ	Baseline, week 3, week 6, week 8	Change in PSQ(Parent Symptom Questionnaire) score between groups over time
Change in TRS	Baseline, week 3, week 6, week 8	Change in TRS (Conners' Teacher Rating Scale, TRS )score between groups over time

Trial Locations

Locations (1)

Department of Psychiatry, Xijing Hospital, The Air Force Medical University; 🇨🇳 Xi'an, Shaanxi, China