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To observe the clinical efficacy and mechanism of functional near-infrared spectroscopy imaging neurofeedback therapy for attention deficit and hyperactivity disorder.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIRS group | Experimental | Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week. |
|
| Drug group | Other | Children with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine |
|
| Control group | Other | Healthy children, 12 sessions of NIRS feedback, for two sessions per week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS neurofeedback | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SNAP-IV | Change in SNAP-IV(Swanson, Nolan, and Pelham-IV rating scales) score between groups over time | Baseline, week 3, week 6, week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CGI | Change in CGI (Clinical Global Impression Scale) score between groups over time | Baseline, week 3, week 6, week 8 |
| Change in PSQ | Change in PSQ(Parent Symptom Questionnaire) score between groups over time |
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For ADHD patients:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjun Wu, master | Contact | +86 02984771141 | wenjun104@126.com | |
| Huaning Wang, doctor | Contact | +86 02984771141 | xskzhu@fmmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wenjun Wu, master | Xijing Hospital, The Air Force Medical University | Study Chair |
| Huaning Wang, doctor | Xijing Hospital, The Air Force Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Xijing Hospital, The Air Force Medical University | Recruiting | Xi'an | Shaanxi | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22146580 | Result | Inoue Y, Sakihara K, Gunji A, Ozawa H, Kimiya S, Shinoda H, Kaga M, Inagaki M. Reduced prefrontal hemodynamic response in children with ADHD during the Go/NoGo task: a NIRS study. Neuroreport. 2012 Jan 25;23(2):55-60. doi: 10.1097/WNR.0b013e32834e664c. | |
| 25928870 | Result | Mayer K, Wyckoff SN, Fallgatter AJ, Ehlis AC, Strehl U. Neurofeedback as a nonpharmacological treatment for adults with attention-deficit/hyperactivity disorder (ADHD): study protocol for a randomized controlled trial. Trials. 2015 Apr 18;16:174. doi: 10.1186/s13063-015-0683-4. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Methylphenidate or Tomoxetine | Drug | Methylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD |
|
| Baseline, week 3, week 6, week 8 |
| Change in TRS | Change in TRS (Conners' Teacher Rating Scale, TRS )score between groups over time | Baseline, week 3, week 6, week 8 |
| Yi Zhang, professor |
| Xidian University |
| Principal Investigator |
| 27238063 | Result | Cortese S, Ferrin M, Brandeis D, Holtmann M, Aggensteiner P, Daley D, Santosh P, Simonoff E, Stevenson J, Stringaris A, Sonuga-Barke EJ; European ADHD Guidelines Group (EAGG). Neurofeedback for Attention-Deficit/Hyperactivity Disorder: Meta-Analysis of Clinical and Neuropsychological Outcomes From Randomized Controlled Trials. J Am Acad Child Adolesc Psychiatry. 2016 Jun;55(6):444-55. doi: 10.1016/j.jaac.2016.03.007. Epub 2016 Apr 1. |
| 30096196 | Result | Hudak J, Rosenbaum D, Barth B, Fallgatter AJ, Ehlis AC. Functionally disconnected: A look at how study design influences neurofeedback data and mechanisms in attention-deficit/hyperactivity disorder. PLoS One. 2018 Aug 10;13(8):e0200931. doi: 10.1371/journal.pone.0200931. eCollection 2018. |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011437 | Propylamines |
| D000588 | Amines |