NCT04065906

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Neurofeedback
• Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-01-15
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2019-08-22
• Last updated: 2019-08-22

Locations

1 site across 1 country: China