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

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04065906
• Other study ID #: KY20192044-F-1
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2019
• Source: Xijing Hospital
• Contact: Wenjun Wu, master
• Phone: +86 02984771141
• Email: wenjun104[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Disease
• Hyperkinesis
• Neurofeedback

Intervention

Behavioral:
• NIRS neurofeedback
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.

Drug:
• Methylphenidate or Tomoxetine
Methylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD

Locations

Country	Name	City	State
China	Department of Psychiatry, Xijing Hospital, The Air Force Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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 Cl — View 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/jour — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in CGI	Change in CGI (Clinical Global Impression Scale) score between groups over time	Baseline, week 3, week 6, week 8
Secondary	Change in PSQ	Change in PSQ(Parent Symptom Questionnaire) score between groups over time	Baseline, week 3, week 6, week 8
Secondary	Change in TRS	Change in TRS (Conners' Teacher Rating Scale, TRS )score between groups over time	Baseline, week 3, week 6, week 8