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临床试验/NCT01363544
NCT01363544已完成2 期

Train Your Brain? Exercise and Neurofeedback Intervention for ADHD

R. van Mourik6 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
112
试验地点
6
主要终点
Improvement in Behaviour

研究概览

简要总结

Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that has a severe impact on a child's life and society. The core symptoms are attention problems, hyperactivity and impulsivity. These symptoms are related to disruptions in neurocognitive functions (such as inhibition: the ability to stop behavior) and disruptions in cortical regulation (such as 'cortical underarousal' as measured with the electroencephalogram). To date, the only evidence-based treatment is pharmacological. Medication is not effective in 20-30% of the children with ADHD and it can have side effects. The lack of alternatives for medication is a severe problem for these children and society.

Neurofeedback is becoming increasingly popular for treating ADHD. Neurofeedback is a training in which a person learns to alter its cortical regulation. Neurofeedback has been classified as 'probably effective' but its treatment effects need further empirical evidence. Non specific training effects, such as individual attention, may also contribute to treatment success. In this research project the investigators compare the efficacy of neurofeedback with exercise, a second non-pharmacological treatment, that may be comparable with neurofeedback in terms of non-specific effects. Exercise is also a promising treatment because of its positive effects on behavior, neurocognition in several patient groups. For these reasons, exercise deserves systematic research in ADHD. Furthermore, the investigators compare the efficacy of these two treatments with an optimal pharmacological treatment with methylphenidate (MPH). The main question is if neurofeedback and exercise are comparable in efficacy with MPH for treating ADHD. The primary outcome measure is behaviour (symptoms of ADHD). Secondary outcome measures include neurocognition and cortical regulation. This research project will give answer to the question if neurofeedback and exercise are as effective as MPH. Furthermore, it will give insight in how these interventions will give rise to improvements in behavior.

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
None

入排标准

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

入选标准

  • ADHD diagnosis
  • IQ above 80

排除标准

  • neurological disorder
  • severe physical or cognitive disability

研究组 & 干预措施

Neurofeedback

Experimental

干预措施: Neurofeedback (Other)

Exercise

Experimental

干预措施: Exercise (Behavioral)

methylphenidate

Active Comparator

optimum dose of methylphenidate (assessed by a double blind placebo-controlled procedure)

干预措施: methylphenidate (Drug)

结局指标

主要结局

Improvement in Behaviour

时间窗: Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2)

Behaviour is assessed with rating scales (SWAN, SDQ, SDSC,DCD) and actigraphy

次要结局

  • Improvement in neurocognition(Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2))
  • Improvement in neurophysiology(Within 2 weeks after the end of treatment (T1) and 6 months after the end of treatment (T2))

研究者

发起方
R. van Mourik
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

R. van Mourik

Dr

VU University of Amsterdam

研究点 (6)

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