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RECRUITINGINTERVENTIONAL

Individualized Alpha Neurofeedback for ADHD

Examine the Effectiveness of Individualized Alpha Neurofeedback for Children With ADHD, a Triple-blinded Randomised Control Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

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.

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

Locations (1)

Li Ka Shing Faculty of Medicine
Hong Kong, Hong Kong, Hong Kong