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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04065906
Enrollment
90
Registered
2019-08-22
Start date
2019-01-15
Completion date
2020-12-31
Last updated
2019-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder (ADHD), Neurofeedback

Keywords

NIRS, fNIRS, neurofeedback, attention deficit hyperactivity disorder (ADHD), children

Brief 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.

Interventions

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.

DRUGMethylphenidate or Tomoxetine

Methylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Change in SNAP-IVBaseline, week 3, week 6, week 8Change in SNAP-IV(Swanson, Nolan, and Pelham-IV rating scales) score between groups over time

Secondary

MeasureTime frameDescription
Change in CGIBaseline, week 3, week 6, week 8Change in CGI (Clinical Global Impression Scale) score between groups over time
Change in PSQBaseline, week 3, week 6, week 8Change in PSQ(Parent Symptom Questionnaire) score between groups over time
Change in TRSBaseline, week 3, week 6, week 8Change in TRS (Conners' Teacher Rating Scale, TRS )score between groups over time

Countries

China

Contacts

Primary ContactWenjun Wu, master
wenjun104@126.com+86 02984771141
Backup ContactHuaning Wang, doctor
xskzhu@fmmu.edu.cn+86 02984771141

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026