NeurofeedbackNCT04065906
Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
A study testing NIRS neurofeedback and Methylphenidate or Tomoxetine in people with Neurofeedback and Attention Deficit Hyperactivity Disorder (ADHD), run by Xijing Hospital at 1 site in China.
Trial summary
To observe the clinical efficacy and mechanism of functional near-infrared spectroscopy imaging neurofeedback therapy for attention deficit and hyperactivity disorder. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurofeedback, Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- NIRS neurofeedback and Methylphenidate or Tomoxetine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- diagnosed with TD, according to the American Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5);
- aged 6-12;
- right handed;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Psychiatry, Xijing Hospital, The Air Force Medical University
Xi'an, Shaanxi
Wenjun Wu, master, +86 02984771141, wenjun104@126.com
Huaning Wang, doctor, +86 02984771141, xskzhu@fmmu.edu.cn
About this study
To observe the clinical efficacy and mechanism of functional near-infrared spectroscopy imaging neurofeedback therapy for attention deficit and hyperactivity disorder.
Read the 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.
- Being tested
- NIRS neurofeedback, Methylphenidate or Tomoxetine
- Keywords
- NIRS, fNIRS, neurofeedback, attention deficit hyperactivity disorder (ADHD), children
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS neurofeedbackBehavioural
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.
Methylphenidate or TomoxetineDrug
Methylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD
| Study group | Role | What they receive |
|---|---|---|
| NIRS group | Experimental | Children with ADHD, 12 sessions of NIRS feedback, for two sessions per week. Receives: Behavioral: NIRS neurofeedback |
| Drug group | Other | Children with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine Receives: Drug: Methylphenidate or Tomoxetine |
| Control group | Other | Healthy children, 12 sessions of NIRS feedback, for two sessions per week. Receives: Behavioral: NIRS neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SNAP-IV
Change in SNAP-IV(Swanson, Nolan, and Pelham-IV rating scales) score between groups over time
Measured: Baseline, week 3, week 6, week 8
Secondary outcomes (3)
Change in CGI
Change in CGI (Clinical Global Impression Scale) score between groups over time
Measured: Baseline, week 3, week 6, week 8
Change in PSQ
Change in PSQ(Parent Symptom Questionnaire) score between groups over time
Measured: Baseline, week 3, week 6, week 8
Change in TRS
Change in TRS (Conners' Teacher Rating Scale, TRS )score between groups over time
Measured: Baseline, week 3, week 6, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start15 Jan 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NeurofeedbackStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Wenjun-1, Xijing Hospital
- Investigators
- Wenjun Wu, master, Study chair, Xijing Hospital, The Air Force Medical UniversityHuaning Wang, doctor, Principal investigator, Xijing Hospital, The Air Force Medical UniversityYi Zhang, professor, Principal investigator, Xidian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065906
- Sponsor's protocol ID
- KY20192044-F-1
- Status last verified
- Aug 2019
- First submitted
- 20 Aug 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22146580Mayer 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.
PubMed 25928870Cortese 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.
PubMed 27238063Hudak 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.
PubMed 30096196
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared Spectroscopy Neurofeedback as a Treatment for Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT04065906
- Acronym / sponsor ID
- KY20192044-F-1
- Keywords
- NIRS, fNIRS, neurofeedback, attention deficit hyperactivity disorder (ADHD), children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NIRS group | Experimental | Behavioral: NIRS neurofeedbackChildren with ADHD, 12 sessions of NIRS feedback, for two sessions per week. |
| Drug group | Other | Drug: Methylphenidate or TomoxetineChildren with ADHD, 6 weeks' treatment of either methylphenidate or tomoxetine |
| Control group | Other | Behavioral: NIRS neurofeedbackHealthy children, 12 sessions of NIRS feedback, for two sessions per week. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- diagnosed with TD, according to the American Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5);
- aged 6-12;
- right handed;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS neurofeedbackNeurofeedback 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. | Behavioural | Control group, NIRS group |
| Methylphenidate or TomoxetineMethylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD | Drug | Drug group |
Primary outcome
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
3 secondary outcomes
Change in CGI
Time frame: Baseline, week 3, week 6, week 8
Change in PSQ
Time frame: Baseline, week 3, week 6, week 8
Change in TRS
Time frame: Baseline, week 3, week 6, week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Results publication: PubMed 22146580Inoue 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.
- Results publication: PubMed 25928870Mayer 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.
- Results publication: PubMed 27238063Cortese 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.
- Results publication: PubMed 30096196Hudak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenjun Wu, master study chair
Xijing Hospital, The Air Force Medical University
Huaning Wang, doctor principal investigator
Xijing Hospital, The Air Force Medical University
Yi Zhang, professor principal investigator
Xidian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRS neurofeedback and Methylphenidate or Tomoxetine in people with Neurofeedback and Attention Deficit Hyperactivity Disorder (ADHD), run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjun Wu, master (+86 02984771141, wenjun104@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SNAP-IV (time frame: Baseline, week 3, week 6, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04065906, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.