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

• Sponsor: Xijing Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04065906
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 23.5
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neurofeedback; Attention Deficit Hyperactivity Disorder (ADHD)	Behavioral: NIRS neurofeedback; Drug: Methylphenidate or Tomoxetine	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
• Actual Study Start Date: Jan 15, 2019
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NIRS group Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week.	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.
Other: Drug group Children with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine	Drug: Methylphenidate or Tomoxetine; Methylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD
Other: Control group Healthy children, 12 sessions of NIRS feedback, for two sessions per week.	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.

Outcome Measures

Primary Outcome Measures

1. Change in SNAP-IV [Baseline, week 3, week 6, week 8]

   Change in SNAP-IV(Swanson, Nolan, and Pelham-IV rating scales) score between groups over time

Secondary Outcome Measures

1. Change in CGI [Baseline, week 3, week 6, week 8]

   Change in CGI (Clinical Global Impression Scale) score between groups over time

2. Change in PSQ [Baseline, week 3, week 6, week 8]

   Change in PSQ(Parent Symptom Questionnaire) score between groups over time

3. Change in TRS [Baseline, week 3, week 6, week 8]

   Change in TRS (Conners' Teacher Rating Scale, TRS )score between groups over time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry, Xijing Hospital, The Air Force Medical University	Xi'an	Shaanxi	China

Sponsors and Collaborators

• Xijing Hospital

Investigators

• Study Chair: Wenjun Wu, master, Xijing Hospital, The Air Force Medical University
• Principal Investigator: Huaning Wang, doctor, Xijing Hospital, The Air Force Medical University
• Principal Investigator: Yi Zhang, professor, Xidian University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wu Wenjun-1, Department of Psychiatry, Xijing Hospital, The Air Force Medical University, Xijing Hospital
• ClinicalTrials.gov Identifier: NCT04065906
• Other Study ID Numbers: KY20192044-F-1
• First Posted: Aug 22, 2019
• Last Update Posted: Aug 22, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Wu Wenjun-1, Department of Psychiatry, Xijing Hospital, The Air Force Medical University, Xijing Hospital: NIRS; fNIRS; neurofeedback; attention deficit hyperactivity disorder (ADHD); children
• Additional relevant MeSH terms: Hyperkinesis; Disease; Attention Deficit Disorder with Hyperactivity; Methylphenidate; Atomoxetine Hydrochloride

Study Results

No Results Posted as of Aug 22, 2019