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

NCT ID: NCT04065906

Last Updated: 2019-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neurofeedback Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NIRS group

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

Group Type EXPERIMENTAL

NIRS neurofeedback

Intervention Type 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.

Drug group

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

Group Type OTHER

Methylphenidate or Tomoxetine

Intervention Type DRUG

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

Control group

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

Group Type OTHER

NIRS neurofeedback

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Methylphenidate or Tomoxetine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wu Wenjun-1

Department of Psychiatry, Xijing Hospital, The Air Force Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenjun Wu, master

Role: STUDY_CHAIR

Xijing Hospital, The Air Force Medical University

Huaning Wang, doctor

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital, The Air Force Medical University

Yi Zhang, professor

Role: PRINCIPAL_INVESTIGATOR

Xidian University

Locations

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Department of Psychiatry, Xijing Hospital, The Air Force Medical University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenjun Wu, master

Role: CONTACT

+86 02984771141

Huaning Wang, doctor

Role: CONTACT

+86 02984771141

Facility Contacts

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Wenjun Wu, master

Role: primary

+86 02984771141

Huaning Wang, doctor

Role: backup

+86 02984771141

References

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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.

Reference Type RESULT
PMID: 22146580 (View on PubMed)

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.

Reference Type RESULT
PMID: 25928870 (View on PubMed)

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.

Reference Type RESULT
PMID: 27238063 (View on PubMed)

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.

Reference Type RESULT
PMID: 30096196 (View on PubMed)

Other Identifiers

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KY20192044-F-1

Identifier Type: -

Identifier Source: org_study_id

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