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

NCT04065906 | Unknown DMC

• 1 other identifier: KY20192044-F-1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neurofeedback; Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

NIRS; fNIRS; neurofeedback; attention deficit hyperactivity disorder (ADHD); children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in CGI

  Baseline, week 3, week 6, week 8

• Change in PSQ

  Baseline, week 3, week 6, week 8

• Change in TRS

  Baseline, week 3, week 6, week 8

Study Arms (3)

NIRS group

EXPERIMENTAL

Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week.

Behavioral: NIRS neurofeedback

Drug group

OTHER

Children with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine

Drug: Methylphenidate or Tomoxetine

Control group

OTHER

Healthy children, 12 sessions of NIRS feedback, for two sessions per week.

Behavioral: NIRS neurofeedback

Interventions

NIRS neurofeedback BEHAVIORAL

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.

Control group; NIRS group

Methylphenidate or Tomoxetine DRUG

Methylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD

Drug group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• diagnosed with TD, according to the American Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5);
• aged 6-12;
• right handed;

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of Psychiatry, Xijing Hospital, The Air Force Medical University

Xi'an, Shaanxi, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 22146580 RESULT

• 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.

  PMID: 25928870 RESULT

• 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.

  PMID: 27238063 RESULT

• 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.

  PMID: 30096196 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propylamines; Amines

Study Officials

• Wenjun Wu, master

  Xijing Hospital, The Air Force Medical University

  STUDY CHAIR

• Huaning Wang, doctor

  Xijing Hospital, The Air Force Medical University

  PRINCIPAL INVESTIGATOR

• Yi Zhang, professor

  Xidian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjun Wu, master

CONTACT

+86 02984771141; wenjun104@126.com

Huaning Wang, doctor

CONTACT

+86 02984771141; xskzhu@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Psychiatry, Xijing Hospital, The Air Force Medical University

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 22, 2019
• Study Start: January 15, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)