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

August 20, 2019 updated by: Wu Wenjun-1, Xijing Hospital
To observe the clinical efficacy and mechanism of functional near-infrared spectroscopy imaging neurofeedback therapy for attention deficit and hyperactivity disorder.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • Department of Psychiatry, Xijing Hospital, The Air Force Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in SNAP-IV
Time Frame: Baseline, week 3, week 6, week 8
Change in SNAP-IV(Swanson, Nolan, and Pelham-IV rating scales) score between groups over time
Baseline, week 3, week 6, week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in CGI
Time Frame: Baseline, week 3, week 6, week 8
Change in CGI (Clinical Global Impression Scale) score between groups over time
Baseline, week 3, week 6, week 8
Change in PSQ
Time Frame: Baseline, week 3, week 6, week 8
Change in PSQ(Parent Symptom Questionnaire) score between groups over time
Baseline, week 3, week 6, week 8
Change in TRS
Time Frame: Baseline, week 3, week 6, week 8
Change in TRS (Conners' Teacher Rating Scale, TRS )score between groups over time
Baseline, week 3, week 6, week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

August 20, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (Actual)

August 22, 2019

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20192044-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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