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临床试验/NCT06142786
NCT06142786已完成不适用

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

The University of Hong Kong2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Conners CPT (Conners Continuous Performance Test)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
5 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Individualized alpha neurofeedback

Experimental

干预措施: Enhancing the individualized upper alpha frequency band and suppressing the lower alpha band. (Behavioral)

Sham neurofeedback

Sham Comparator

干预措施: Sham neurofeedback (Behavioral)

结局指标

主要结局

Conners CPT (Conners Continuous Performance Test)

时间窗: prior to the intervention, immediate after the intervention

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.

Strengths and Weaknesses of Attention-Deficit/Hyperactivity Symptoms and Normal Behavior Scale (SWAN)

时间窗: prior to the intervention, immediate after the interventions & 6 months after the intervention

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.

Conners CPT (Conners Continuous Performance Test)

时间窗: prior to the intervention, immediate after the intervention

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.

次要结局

  • the Wechsler Intelligence Scale for Children (WISC):(prior to the intervention, immediate after the intervention)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Winnie Wan Yee Tso (Dr)

Clinical Assistant professor

The University of Hong Kong

研究点 (2)

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