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

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Neurofeedback; Attention Deficit Hyperactivity Disorder (ADHD)

Treatments: Behavioral: NIRS neurofeedback; Drug: Methylphenidate or Tomoxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT04065906

KY20192044-F-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

NIRS group

Experimental group

Description:

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

Treatment:

Behavioral: NIRS neurofeedback

Drug group

Other group

Description:

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

Treatment:

Drug: Methylphenidate or Tomoxetine

Control group

Other group

Description:

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

Treatment:

Behavioral: NIRS neurofeedback