Clinical trial NCT04065906: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Neurofeedback
Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: NIRS
fNIRS
neurofeedback
attention deficit hyperactivity disorder (ADHD)
children
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in SNAP-IV
timeFrame: Baseline, week 3, week 6, week 8
Secondary outcomes:
measure: Change in CGI
timeFrame: Baseline, week 3, week 6, week 8
measure: Change in PSQ
timeFrame: Baseline, week 3, week 6, week 8
measure: Change in TRS
timeFrame: Baseline, week 3, week 6, week 8
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Psychiatry, Xijing Hospital, The Air Force Medical University
state: Shaanxi
Study officials:
affiliation: Xijing Hospital, The Air Force Medical University
name: Wenjun Wu, master
role: STUDY_CHAIR
affiliation: Xijing Hospital, The Air Force Medical University
name: Huaning Wang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Xidian University
name: Yi Zhang, professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.