Individualized Alpha Neurofeedback for ADHD

NCT ID: NCT06142786

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-12-25

Brief 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 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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Individualized alpha neurofeedback

Group Type: EXPERIMENTAL

Enhancing the individualized upper alpha frequency band and suppressing the lower alpha band.

Intervention Type: BEHAVIORAL

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 neurofeedback

Group Type: SHAM_COMPARATOR

Sham neurofeedback

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Sham neurofeedback

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Winnie Wan Yee Tso (Dr)

Clinical Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Winnie WY Tso, MBBS

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Li Ka Shing Faculty of Medicine

Hong Kong, Hong Kong, Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Yuliang Wang, Mphil

Role: CONTACT

lornewang@connect.hku.hk

+852 51342479

Facility Contacts

Yuliang Wang, Mphil

Role: primary

lornewang@connect.hku.hk

51342479

Yuliang Wang

Role: backup

Other Identifiers

ADHD_NF_HKU

Identifier Type: -

Identifier Source: org_study_id