Clinical trial NCT06142786: Individualized Alpha Neurofeedback for ADHD
Official title: Examine the Effectiveness of Individualized Alpha Neurofeedback for Children With ADHD, a Triple-blinded Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Keywords: ADHD
Neurofeedback
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Strengths and Weaknesses of Attention-Deficit/Hyperactivity Symptoms and Normal Behavior Scale (SWAN)
timeFrame: prior to the intervention, immediate after the interventions & 12 months after the intervention
measure: Conners CPT (Conners Continuous Performance Test)
timeFrame: prior to the intervention, immediate after the intervention
Secondary outcomes:
measure: PedsQL (Pediatric Quality of Life Inventory)
timeFrame: prior to the intervention, immediate after the intervention & 12 months after the intervention
measure: SDQ (Strengths and Difficulties Questionnaire)
timeFrame: prior to the intervention, immediate after the intervention 12 months after the intervention
measure: BRIEF (Behavior Rating Inventory of Executive Function)
timeFrame: prior to the intervention, immediate after the intervention & 12 months after the intervention
measure: The Child Behavior Checklist (CBCL)
timeFrame: prior to the intervention, immediate after the intervention & 12 months after the intervention
measure: the Wechsler Intelligence Scale for Children (WISC):
timeFrame: prior to the intervention, immediate after the intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Li Ka Shing Faculty of Medicine
Study officials:
affiliation: The University of Hong Kong
name: Winnie WY Tso, MBBS
role: PRINCIPAL_INVESTIGATOR
References: