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临床试验/NCT02333422
NCT02333422Unknown2 期

Clinical Trial Using NIRS Neurofeedback on Children With Attention Deficit Hyperactivity Disorder (ADHD)

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年7月最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
10
试验地点
2
主要终点
Diagnostic and severity measure

研究概览

简要总结

The investigators therefore propose a pilot study to establish the effectiveness of NIRS Neurofeedback training in reducing the intensity of ADHD symptom expression on children, improvement of the cognitive and global functions associated with ADHD, effects on cerebral blood perfusion in the cortex and safety plus possible unknown side-effects.

详细描述

Background:

Attention Deficit Hyperactivity Disorder (ADHD) is a mental condition originating in childhood, characterized by symptoms of lack attention, hyperactivity and impulsiveness associated with significant functional impairment. Currently, the use of neurofeedback as a non-drug alternative technique for treatment of ADHD has increasingly spread among the clinical and academic fields, producing relevant findings with regard to its effectiveness. The SCP Neurofeedback and EEG Neurofeedback have been the most studied techniques until the moment, with equipments and systems made available to the market at prices between US$ 10.000 and US$ 20.000, while NIRS Neurofeedback equipments can be found for around US$ 2.000. Due to the low cost of the necessary equipment's and easy access to the technology, the use of NIRS Neurofeedback was opted for in the search to evaluate the techniques effectiveness in the improvement of ADHD symptoms as well as the patients' cognitive performance.

This research is an open label treatment trial with NIRS Neurofeedback training of frontal and pre frontal lobes activation in children school-aged 7 - 12 years old with ADHD. Ten participants will be recruited over 3 months and will be offered 24 NIRS Neurofeedback sessions over 12 weeks, 2 sessions per week. The present study will be carried out as part of the care routine of the Child and Adolescent Psychiatry Services at Hospital de Clínicas de Porto Alegre. Primary outcome will be standard clinical behavioural rating scales. Secondary outcomes will include neuropsychological parameters, neurofunctional parameters using SPECT (Single Photon Emission Computed Tomography), global function, quality of life assessment, side effects and tolerability.

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 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with ADHD clinically.
  • Cognitive dysfunction: ≥11/2; standard deviation above norm in at least two neuropsychological measurements: executive functions (inhibitory control), gratification aversion and time processing
  • Not having used ADHD medication in at least three months with parental consent for not treating ADHD with medication

排除标准

  • Existence of another co-morbid mental disorder which is clinically relevant and demands treatment

研究组 & 干预措施

NIRS Neurofeedback

Experimental

NIRS Neurofeedback training of frontal and pre frontal lobes activation. The intervention consist of 24 NIRS neurofeedback sessions over 12 weeks, 2 sessions per week.

干预措施: NIRS Neurofeedback (Other)

结局指标

主要结局

Diagnostic and severity measure

时间窗: 3 months

Swanson, Nolan and Pelham Questionnaire version IV (SNAPIV)

次要结局

  • Basic processing(3 months)
  • Inhibition control(3 months)
  • Conflict Control(3 months)
  • Time processing(3 months)
  • Delay Aversion(3 months)
  • Psychiatric and social function measure(3 months)
  • Treatment response assessment(3 months)
  • Quality of life(3 months)
  • Side Effects(3 months)
  • Cerebral blood perfusion(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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