The University of Hong Kong
Winnie Wan Yee Tso (Dr)
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).
ADHD
Enhancing the individualized upper alpha frequency band and suppressing the lower alpha band.
Sham neurofeedback
NA
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 12-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 Type : | INTERVENTIONAL |
| Estimated Enrollment : | 120 participants |
| Masking : | QUADRUPLE |
| Masking Description : | Participants, their parents/guardians, the neurofeedback/sham feedback trainer, the investigator, and outcome assessors will be blinded to the allocation of conditions. An independent senior research assistant from our team, who is not involved in the mentioned roles, will execute the random allocation algorithm and set the neurofeedback training protocol (either verum or sham) before each visit |
| Primary Purpose : | TREATMENT |
| Official Title : | Examine the Effectiveness of Individualized Alpha Neurofeedback for Children with ADHD, a Triple-blinded Randomised Control Trial |
| Actual Study Start Date : | 2024-06-01 |
| Estimated Primary Completion Date : | 2025-12-25 |
| Estimated Study Completion Date : | 2026-12-25 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 4 Years to 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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RECRUITING
Li Ka Shing Faculty of Medicine
Hong Kong, Hong Kong, 0000