Individualized Alpha Neurofeedback for ADHD

NCT06142786 | Recruiting

• 1 other identifier: ADHD_NF_HKU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

ADHD

Keywords

ADHD; Neurofeedback

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  prior to the intervention, immediate after the intervention

Secondary Outcomes (4)

• PedsQL (Pediatric Quality of Life Inventory)

  prior to the intervention, immediate after the intervention & 6 months after the intervention

• SDQ (Strengths and Difficulties Questionnaire)

  prior to the intervention, immediate after the intervention 6 months after the intervention

• The Child Behavior Checklist (CBCL)

  prior to the intervention, immediate after the intervention & 6 months after the intervention

• the Wechsler Intelligence Scale for Children (WISC):

  prior to the intervention, immediate after the intervention

Study Arms (2)

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

Interventions

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

Individualized alpha neurofeedback

Sham neurofeedback 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

Sham neurofeedback

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Li Ka Shing Faculty of Medicine

Hong Kong, Hong Kong, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Winnie WY Tso, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuliang Wang, Mphil

CONTACT

+852 51342479; lornewang@connect.hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant professor

Model Details: 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.

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: June 1, 2024
• Primary Completion: December 25, 2025
• Study Completion (Estimated): December 25, 2026
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

HK (1)