ADHDNCT06142786
Individualized Alpha Neurofeedback for ADHD
A study testing Enhancing the individualized upper alpha frequency band and suppressing the lower alpha band. in people with ADHD, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Attention deficit hyperactivity disorder (ADHD) is one of the most prevalent neurodevelopmental disorders, characterised by inattention, hyperactivity, and impulsivity. Although pharmacotherapy is considered the first-line treatment for ADHD at all ages (at least for severe cases), non-pharmacological therapies might… Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- ADHD
- What is being tested?
- Enhancing the individualized upper alpha frequency band and suppressing the lower alpha band.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2024to 1 Jun 2025
- 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 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Fulfilment of the DSM-IV-TR criteria for ADHD
- No intention to use new medication/change dosage/join new non-pharmacological treatment program during the intervention period.
Who cannot join
- Diagnosis of cerebral palsy/ history of structural brain abnormalities on CT/ MRI;
- full-scale IQ score (FSIQ) < 70;
- A history of seizure or prior electroencephalogram abnormalities related to epilepsy.
- Having comorbid psychiatric disorders, including schizophrenia or schizoaffective disorder, bipolar disorder, borderline personality disorder, epilepsy, or traumatic brain injury; current substance abuse or dependence
- Planned other behavioural/durg treatment during the intervention period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examine the Effectiveness of Individualized Alpha Neurofeedback for Children With ADHD, a Triple-blinded Randomised Control Trial
Attention deficit hyperactivity disorder (ADHD) is one of the most prevalent neurodevelopmental disorders, characterised by inattention, hyperactivity, and impulsivity. Although pharmacotherapy is considered the first-line treatment for ADHD at all ages (at least for severe cases), non-pharmacological therapies might be equally effective without the risk of drug side effects. Some studies have shown that electroencephalographic (EEG) neurofeedback improves parent-rated ADHD symptoms in children and adolescents. However, whether neurofeedback is an effective treatment for ADHD is still under debate.
Several issues may hinder the evaluation of the effectiveness of neurofeedback treatment in previous studies. Firstly, previous neurofeedback studies did not utilize effective neurophysiological markers for ADHD. Theta/Beta ratio, the most common neurofeedback marker for treating ADHD in the past two decades, has recently been suggested to be only weakly correlated to individuals' attention. Secondly, previous studies mostly used the norm of the EEG markers in age/gender matched healthy children as the training target for ADHD children, which largely ignored the individual variations in EEG acquisition. Third, most of the previous studies lack a rigorous study design, for comparing neurofeedback with a 'placebo' condition and evaluating its specific and non-specific effects.
In the current studies, we propose to conduct a sham-controlled, triple-blind trial to evaluate the effectiveness of an individual-based neurofeedback treatment for ADHD children and adolescents. The EEG marker for neurofeedback in treating ADHD would be the individualized lower/higher alpha band power, based on the recent methodological advances in EEG spectrum processing (1/f model fit and individualized peak alpha frequency modelling) . The training target will be individualized and defined according to the neurophysiological pattern shown in pre-training resting-state conditions, and thus each participant will be trained to achieve their own optimum state of engagement. Sham neurofeedback will be used as a placebo condition, controlling for the non-specific effect of neurofeedback. The study will be triple-blinded (i.e, participants, individuals who administered treatment or intervention, and those who assessed the outcomes were masked).
Read the detailed description
120 ADHD children will be invited to join the RCT neurofeedback training. They will be randomly assigned to one of two groups (neurofeedback group, sham feedback group, ). For the neurofeedback group participants will undergo an 4-week neurofeedback training (twice a week); for the sham feedback group， participants will undergo an 4-week sham feedback training (twice a week), All the groups will conduct cognitive and EEG tests before and after the 4-week period and the investigators will follow up with all the participants immediately after the training and 6-month after the training. When recruiting, participants and parents of the participants will be notified that their children are likely to be assigned to one of the three groups, and for the neurofeedback and sham feedback group, the parents and participants will not know which condition they are enrolled in, until the end of the study. By the end of the study, participants from the sham feedback group will be given an opportunity to rejoin a neurofeedback session for compensation.
- Conditions
- ADHD
- Being tested
- Enhancing the individualized upper alpha frequency band and suppressing the lower alpha band., Sham neurofeedback
- Keywords
- ADHD, Neurofeedback
- 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.
Enhancing the individualized upper alpha frequency band and suppressing the lower alpha band.Behavioural
Real time visual feedback will be given the participants, such that as the higher/lower alpha power increases (relative to the mean value in the pre-training resting state EEG recording) a plane on the screen will move horizontally (the movement is correspondent to the magnitude of upper/lower alpha ratio), and the animation will change based on EEG parameter every 2 seconds. EMG-based feedback is also provided, such that if the children's EMG level is too high the plane will drop (vertical movement). Participants are instructed to 'fly' the plane as far as possible.
Sham neurofeedbackBehavioural
The sham neurofeedback protocol was identical to the verum neurofeedback protocol except that the animation (horizontal plane movement) was based on the EEG results of another participant. EMG-based feedback will still be provided for the sham condition
| Study group | Role | What they receive |
|---|---|---|
| Individualized alpha neurofeedback | Experimental | Not described Receives: Behavioral: Enhancing the individualized upper alpha frequency band and suppressing the lower alpha band. |
| Sham neurofeedback | Sham comparator | Not described Receives: Behavioral: Sham neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strengths and Weaknesses of Attention-Deficit/Hyperactivity Symptoms and Normal Behavior Scale (SWAN)
The Chinese SWAN is a validated instrument for the assessment of ADHD symptoms in Chinese children in Hong Kong. The SWAN questionnaire was originally devised by Swanson et al in 2005 based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for ADHD.
Measured: prior to the intervention, immediate after the interventions & 6 months after the intervention
Conners CPT (Conners Continuous Performance Test)
The Conners Continuous Performance Test (CPT) is a computerized neuropsychological assessment designed to evaluate attention, impulsivity, and vigilance in children and adolescents aged 8-18 years. The test involves the presentation of letters on a computer screen, where the participant must respond to specific target letters while ignoring others. The Conners CPT provides measures of response time, errors, and variability, which can aid in the identification of attention deficit hyperactivity disorder (ADHD) and other attention-related problems.
Measured: prior to the intervention, immediate after the intervention
Secondary outcomes (4)
PedsQL (Pediatric Quality of Life Inventory)
The Pediatric Quality of Life Inventory (PedsQL) is a reliable and validated instrument for assessing health-related quality of life in children and adolescents aged 2-18 years. It consists of 23 items, covering four domains: physical functioning, emotional functioning, social functioning, and school functioning. The PedsQL is designed to measure the impact of various health conditions on children's daily lives and well-being.
Measured: prior to the intervention, immediate after the intervention & 6 months after the intervention
SDQ (Strengths and Difficulties Questionnaire)
The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioral screening questionnaire for children and adolescents aged 2-17 years. It consists of 25 items, covering five domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. The SDQ is designed to help identify mental health problems and promote emotional well-being in children and adolescents.
Measured: prior to the intervention, immediate after the intervention 6 months after the intervention
The Child Behavior Checklist (CBCL)
The CBCL is a 120 item parent-report, which provides a measure of behavioral and emotional functioning and social competence of youth, aged six to 18
Measured: prior to the intervention, immediate after the intervention & 6 months after the intervention
the Wechsler Intelligence Scale for Children (WISC):
The Wechsler Intelligence Scale for Children (WISC) is a comprehensive, standardized intelligence test designed for children and adolescents aged 6-16 years. The WISC measures cognitive abilities across various domains, including verbal comprehension, visual-spatial abilities, fluid reasoning, working memory, and processing speed. The test consists of several subtests, each designed to assess different aspects of cognitive functioning. The WISC is widely used in educational and clinical settings to help identify learning difficulties, intellectual giftedness, and other cognitive issues that may impact a child's academic performance and daily functioning
Measured: prior to the intervention, immediate after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start1 Jan 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once eligible participants are enrolled in this study, they will be randomly allocated either to the neurofeedback intervention group or the sham feedback group. Participants in both groups will receive treatment/sham treatment at the same period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winnie Wan Yee Tso (Dr), The University of Hong Kong
- Investigators
- Winnie WY Tso, MBBS, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142786
- Sponsor's protocol ID
- ADHD_NF_HKU
- Status last verified
- May 2026
- First submitted
- 15 Nov 2023
- Last updated
- 2 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examine the Effectiveness of Individualized Alpha Neurofeedback for Children With ADHD, a Triple-blinded Randomised Control Trial
- ClinicalTrials.gov ID
- NCT06142786
- Acronym / sponsor ID
- ADHD_NF_HKU
- Conditions
- ADHD
- Keywords
- ADHD, Neurofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 21 Nov 2023 (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.
Attention deficit hyperactivity disorder (ADHD) is one of the most prevalent neurodevelopmental disorders, characterised by inattention, hyperactivity, and impulsivity. Although pharmacotherapy is considered the first-line treatment for ADHD at all ages (at least for severe cases), non-pharmacological therapies might be equally effective without the risk of drug side effects. Some studies have shown that electroencephalographic (EEG) neurofeedback improves parent-rated ADHD symptoms in children and adolescents. However, whether neurofeedback is an effective treatment for ADHD is still under debate.
Several issues may hinder the evaluation of the effectiveness of neurofeedback treatment in previous studies. Firstly, previous neurofeedback studies did not utilize effective neurophysiological markers for ADHD. Theta/Beta ratio, the most common neurofeedback marker for treating ADHD in the past two decades, has recently been suggested to be only weakly correlated to individuals' attention. Secondly, previous studies mostly used the norm of the EEG markers in age/gender matched healthy children as the training target for ADHD children, which largely ignored the individual variations in EEG acquisition. Third, most of the previous studies lack a rigorous study design, for comparing neurofeedback with a 'placebo' condition and evaluating its specific and non-specific effects.
In the current studies, we propose to conduct a sham-controlled, triple-blind trial to evaluate the effectiveness of an individual-based neurofeedback treatment for ADHD children and adolescents. The EEG marker for neurofeedback in treating ADHD would be the individualized lower/higher alpha band power, based on the recent methodological advances in EEG spectrum processing (1/f model fit and individualized peak alpha frequency modelling) . The training target will be individualized and defined according to the neurophysiological pattern shown in pre-training resting-state conditions, and thus each participant will be trained to achieve their own optimum state of engagement. Sham neurofeedback will be used as a placebo condition, controlling for the non-specific effect of neurofeedback. The study will be triple-blinded (i.e, participants, individuals who administered treatment or intervention, and those who assessed the outcomes were masked).
Detailed description
120 ADHD children will be invited to join the RCT neurofeedback training. They will be randomly assigned to one of two groups (neurofeedback group, sham feedback group, ). For the neurofeedback group participants will undergo an 4-week neurofeedback training (twice a week); for the sham feedback group， participants will undergo an 4-week sham feedback training (twice a week), All the groups will conduct cognitive and EEG tests before and after the 4-week period and the investigators will follow up with all the participants immediately after the training and 6-month after the training. When recruiting, participants and parents of the participants will be notified that their children are likely to be assigned to one of the three groups, and for the neurofeedback and sham feedback group, the parents and participants will not know which condition they are enrolled in, until the end of the study. By the end of the study, participants from the sham feedback group will be given an opportunity to rejoin a neurofeedback session for compensation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Once eligible participants are enrolled in this study, they will be randomly allocated either to the neurofeedback intervention group or the sham feedback group. Participants in both groups will receive treatment/sham treatment at the same period.
| Arm | Type | Receives |
|---|---|---|
| Individualized alpha neurofeedback | Experimental | Behavioral: Enhancing the individualized upper alpha frequency band and suppressing the lower alpha band. |
| Sham neurofeedback | Sham comparator | Behavioral: Sham neurofeedback |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Fulfilment of the DSM-IV-TR criteria for ADHD
- No intention to use new medication/change dosage/join new non-pharmacological treatment program during the intervention period.
Key exclusion criteria (5 listed)
- Diagnosis of cerebral palsy/ history of structural brain abnormalities on CT/ MRI;
- full-scale IQ score (FSIQ) < 70;
- A history of seizure or prior electroencephalogram abnormalities related to epilepsy.
- Having comorbid psychiatric disorders, including schizophrenia or schizoaffective disorder, bipolar disorder, borderline personality disorder, epilepsy, or traumatic brain injury; current substance abuse or dependence
- Planned other behavioural/durg treatment during the intervention period
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 |
|---|---|---|
| Enhancing the individualized upper alpha frequency band and suppressing the lower alpha band.Real time visual feedback will be given the participants, such that as the higher/lower alpha power increases (relative to the mean value in the pre-training resting state EEG recording) a plane on the screen will move horizontally (the movement is correspondent to the magnitude of upper/lower alpha ratio), and the animation will change based on EEG parameter every 2 seconds. EMG-based feedback is also provided, such that if the children's EMG level is too high the plane will drop (vertical movement). Participants are instructed to 'fly' the plane as far as possible. | Behavioural | Individualized alpha neurofeedback |
| Sham neurofeedbackThe sham neurofeedback protocol was identical to the verum neurofeedback protocol except that the animation (horizontal plane movement) was based on the EEG results of another participant. EMG-based feedback will still be provided for the sham condition | Behavioural | Sham neurofeedback |
Primary outcome
Strengths and Weaknesses of Attention-Deficit/Hyperactivity Symptoms and Normal Behavior Scale (SWAN)
Time frame: prior to the intervention, immediate after the interventions & 6 months after the intervention
The Chinese SWAN is a validated instrument for the assessment of ADHD symptoms in Chinese children in Hong Kong. The SWAN questionnaire was originally devised by Swanson et al in 2005 based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for ADHD.
Conners CPT (Conners Continuous Performance Test)
Time frame: prior to the intervention, immediate after the intervention
The Conners Continuous Performance Test (CPT) is a computerized neuropsychological assessment designed to evaluate attention, impulsivity, and vigilance in children and adolescents aged 8-18 years. The test involves the presentation of letters on a computer screen, where the participant must respond to specific target letters while ignoring others. The Conners CPT provides measures of response time, errors, and variability, which can aid in the identification of attention deficit hyperactivity disorder (ADHD) and other attention-related problems.
4 secondary outcomes
PedsQL (Pediatric Quality of Life Inventory)
Time frame: prior to the intervention, immediate after the intervention & 6 months after the intervention
SDQ (Strengths and Difficulties Questionnaire)
Time frame: prior to the intervention, immediate after the intervention 6 months after the intervention
The Child Behavior Checklist (CBCL)
Time frame: prior to the intervention, immediate after the intervention & 6 months after the intervention
the Wechsler Intelligence Scale for Children (WISC):
Time frame: prior to the intervention, immediate after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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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.
Winnie WY Tso, MBBS principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhancing the individualized upper alpha frequency band and suppressing the lower alpha band. in people with ADHD, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jun 2026. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Weaknesses of Attention-Deficit/Hyperactivity Symptoms and Normal Behavior Scale (SWAN) (time frame: prior to the intervention, immediate after the interventions & 6 months after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.