跳至主要内容
临床试验/NCT02205268
NCT02205268Unknown不适用

A Pilot Study of Near Infrared Spectroscopy Neurofeedback Training of Prefrontal Cortex in Attention Deficit Hyperactivity Disorder

North Essex Partnership NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2013年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
48
试验地点
2
主要终点
Recruitment and retention rates

研究概览

简要总结

Background Attention Deficit Hyperactivity Disorder (ADHD) is one of the most frequently diagnosed behavioural disorders in childhood that requires treatment(3-5% of children). It is an important health problem because it impairs social, educational and occupational performance, and increases the risk of other psychiatric disorders including anxiety, depression and substance misuse. There is no cure for ADHD and standard stimulant medication treatment is at best symptomatic. Moreover, stimulants have side effects and parents are often concerned over the long-term effects. A number of non-drug treatments have been developed but these do not target the brain directly. Neurofeedback Training (NTx) is a new, non-drug treatment that targets the brain directly and that can potentially enhance the control of attention in ADHD. NTx could be a valuable alternative and/or adjunct to standard care.

Aims Although NTx has gained popularity in Europe and the US, more rigorous studies are required to support its implementation in the NHS. We therefore propose a pilot study to establish tolerabilty and safety, and to develop treatment protocols and collect data to design a follow-on controlled NTx trial in ADHD.

Methods We plan an open label, single arm, treatment trial of near infrared spectroscopy neurofeedback training of frontal lobe activation in school-aged children with ADHD. 48 participants will be recruited over 1 year and will be offered 20 NTx sessions over 10 weeks. Participants will be recruited from Mental Health Services. Primary outcomes will be safety and tolerability and secondary outcomes will include standard clinical behavioural rating scales and the Test Of the Variables of Attention.

详细描述

ADHD is one of the most frequently diagnosed conditions in childhood and at least half of patients have symptoms that persist into adulthood. It is important to seek effective treatments for ADHD because children with ADHD often do not reach their full potential and are at increased risk of other psychiatric difficulties in childhood, adolescence and adulthood, including disorders of mood, anxiety, conduct and substance misuse.

Increasingly the available evidence suggest that ADHD may be the result of abnormal levels of certain chemicals and altered brain function. Standard treatment with stimulant medications are aimed at the chemical imbalance and whilst they may help some children, they are of limited benefit in others and of no benefit in more than a quarter of children. Parents are often reluctant to consider medication due to concerns over side effects and the unknown longer term effects of these drugs on their children's developing brains and bodies. Non- drug treatments can provide an alternative and/or adjunct that may overcome some of the concerns about the long-term side effects of drugs. Furthermore, the latest guidelines from the National Institute of Clinical Excellence (NICE, 2008) recommend that medication should only be used as a first-line treatment in severe cases of ADHD. In all other cases it is advised that children receive a group treatment programme and that parents or carers receive parent training and education on ADHD. Whilst these guidelines have been welcomed for promoting alternatives to medication for treating ADHD,concerns have been raised about the feasibility and efficacy of the recommended group interventions for children and individual treatments may be easier to implement and more effective for these children. Therefore, although there are a number of treatments for ADHD, they have limitations in terms of efficacy, tolerability, side effects and practicability. There is therefore a clear rational to investigate new treatments that may be superior in efficacy or valuable as additional or alternative treatments.

Several individual, non-drug interventions for ADHD have emerged over the last thirty years. These include at home parental guidance, classroom based teacher intervention, behavioural therapy, herbal treatment and nutritional supplements. Neurofeedback training appears one of the most promising because the technique directly targets brain functioning in key areas. Neurofeedback training (NTx) uses signals directly from the brain to make subjects aware of brain function. It is an established treatment in epilepsy, migraine and stroke rehabilitation. Abnormal brain function (electrical and blood flow) has been consistently demonstrated in ADHD and may therefore be targeted with neurofeedback. These findings have formed the basis for considering NTx as a potential alternative to medication in the treatment of ADHD.

Compelling evidence from recent controlled studies indicate that NTx that uses electric brain signals (EEG) is a useful treatment in ADHD and that the effects last for at least 6 months. Near infrared spectroscopy neurofeedback (NIRS) neurofeedback training (NIRS NTx) is a newer alternative to EEG NTx. It is easier to administer and may require fewer treatment sessions. NIRS can determine changes in brain activity by measuring changes in the amount of oxygen in the brain. Rather than requiring subjects to alter the pattern of electrical brain activity, NIRSNTx trains subjects to alter blood flow in specific brain areas. Abnormal brain blood flow has been demonstrated in ADHD and typically, these abnormalities include reduced activity of brain areas just behind the forehead.

NIRS NTx is a low cost technique and it can be applied at home, clinic or school. NIRS can safely be applied to the head because the low energy light used for the technique do not cause damage to underlying tissues and is less than 5% of the exposure that occurs in ordinary midday sunlight.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with ADHD aged 7 to 17 years
  • Patient and legal guardian able to communicate in English
  • Patient has been living with parent/guardian for at least six months
  • Patient attending school for at least 2 days / week
  • ADHD as primary disorder with symptoms present for at least 9 months
  • Participants on medication treatment for ADHD must have been on a stable dose for 3 months prior to commencement of the treatment

排除标准

  • Significant visual or hearing impairment that would preclude use of NIRS- neurofeedback
  • Global learning disability, Autism, psychosis, bipolar disorder, depression, suicidal ideation, or another psychiatric disorder requiring treatment with additional psychotropic medication, current substance dependance or regular use, and severe sleep disorders

结局指标

主要结局

Recruitment and retention rates

时间窗: 10 weeks

The primary outcome measure is the percentage of participants who complete 75% of the 20 training sessions offered.

次要结局

  • Diagnostic and severity measure(10 weeks)
  • Adverse effects(10 weeks)
  • Attentional and impulsivity measures(10 weeks)
  • Problem behaviour measure(10 weeks)
  • Study satisfaction questionnaire(10 weeks)
  • Psychiatric and social function measure(10 weeks)
  • Treatment response assessment(10 weeks)

研究者

发起方
North Essex Partnership NHS Foundation Trust
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr Thomas Dannhauser

Chief Investigator

North Essex Partnership NHS Foundation Trust

研究点 (2)

Loading locations...

相似试验