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临床试验/NCT03425669
NCT03425669招募中不适用

Acoustic and Vestibular Noise as Possible Non-pharmacological Treatments of ADHD in School Children

Lund University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
1
主要终点
Go No- go test

研究概览

简要总结

Noise benefit in ADHD Auditory noise benefit: The original findings from our research group, that auditory noise enhances cognitive performance in inattentive children without diagnosis as well as children with an ADHD diagnosis, have been replicated several times (Baijot et al., 2016; Söderlund et al., 2016; Söderlund & Nilsson Jobs, 2016; Söderlund et al., 2007). In a new study, the benefit of noise was shown to be in parity with or even larger than the benefit of pharmacological ADHD treatment on two cognitive tasks, episodic word recall and visuo-spatial working memory task. In the study a group of children diagnosed with ADHD were tested on and off medication, at separate occasions, in noisy vs. silent environments while performing the tasks (Söderlund, Björk et al., 2016).

Participants and recruitment: Participants with an ADHD diagnosis using medication will be recruited from Child and Adolescent Psychiatry in Lund and Malmö. Typically developing children (TDC) and inattentive children without diagnosis will be recruited from schools in collaboration with the municipality.

Experimental design: All participants will perform a double-blind placebo cross over control study. ADHD participants will perform the entire test battery at three occasions with 2-3 weeks intermission in between tests. One occasion with placebo medication and sham SVS stimulation; one occasion with active SVS stimulation; and one occasion with active medication. TD children will only be tested twice while they will not be given any medication or placebo and just perform under SVS vs. sham conditions.

Test battery: 1) Episodic memory will be tested trough Auditory Verbal Learning Test (AVLT) (e.g. Dige et al., 2008). 2) Visuo-spatial working memory will be tested through the Spanboard task (Westerberg et al., 2004). 3) Motor-neurological investigation. 4) A finger tapping task. 5) Evaluation of an iPhone auditory noise application in a normal school setting. Our research group has developed an iPhone application (www.smartnoise.se) that is available at App-store right now. The study will last for about 5 months and participants will be 50 voluntary secondary school pupils that have documented attention difficulties as judged by their teachers. The application will be evaluated both by pupils, teachers and parents.

详细描述

Attention Deficit Hyperactivity disorder (ADHD) is one of the most frequent childhood disorders with an estimated prevalence of about 5-7% (e.g. Ullebo et al., 2012). Today the most common treatment approach is stimulant medication, e.g. methylphenidate (Greenhill et al., 2002; Wigal et al., 2011). However there are many concerns about medication: i) best dose for cognitive functioning and adapted school behavior differs (Hale et al., 2011), ii) it is not even evident that medication improves learning processes (Molina et al., 2009), iii) concerns regarding potential for drug abuse (Gordon et al., 2004); and iv) uncertainties regarding long term effects of drug use on the developing brain (Andersen, 2005).

In both national and international guidelines of ADHD care multimodal treatment is recommended (Young & Amarasinghe, 2010), but most patients only receive pharmacological treatment, sometimes in combination with parent training. If auditory or vestibular noise, as the present project suggests, could be a complement or an alternative to stimulant medication it could fundamentally change the treatment of ADHD and the school situation for those children.

Noise benefit in ADHD Auditory noise benefit: The original findings from our research group, that auditory noise enhances cognitive performance in inattentive children without diagnosis as well as children with an ADHD diagnosis, have been replicated several times (Baijot et al., 2016; Söderlund et al., 2016; Söderlund & Nilsson Jobs, 2016; Söderlund et al., 2007). In a new study, the benefit of noise was shown to be in parity with or even larger than the benefit of pharmacological ADHD treatment on two cognitive tasks, episodic word recall and visuo-spatial working memory task. In the study a group of children diagnosed with ADHD were tested on and off medication, at separate occasions, in noisy vs. silent environments while performing the tasks (Söderlund, Björk et al., 2016). Inattentive and low achieving school children have been shown to improve their memory recall when exposed to noise, whereas attentive and high achieving children perform worse during noise exposure (Helps et al., 2014; Söderlund & Sikström, 2008, 2012; Söderlund et al., 2010).

Vestibular noise benefit: Vestibular stimulation has since long been demonstrated to increase hippocampal activity and hippocampus is well demonstrated to be of crucial importance in detecting and holding on to spatial targets showing that hippocampus is of fundamental for both spatial orientation and learning in general (Moser et al., 2015). Therefore it is not surprising that external stochastic vestibular stimulation (SVS) exerts beneficial effects in different domains, e.g. balance in healthy astronauts (Mulavara et al., 2011), in Parkinson patients (Pal et al., 2009; Samoudi et al., 2014) and response times in continuous performance task (Yamamoto et al., 2005). The theory about noise benefit is thoroughly described by Sikström and Söderlund (2007). 1. The first objective is to systematically evaluate the effects of stochastic vestibular noise on cognitive task performance and to compare these results with the ones of stimulant medication using a double blind RCT (Random Control Trial) design.

The second objective is to implement a practical application, to evaluate if auditory noise can be beneficial in an every day school setting by the use of an iPhone application (see: www.smartnoise.se).

研究设计

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

盲法说明

Participants will be randomized to placebo or stimulant medication during assessments. Participants will be unaware if they will get sham stimulation or SVS (but not the test administrator).

入排标准

年龄范围
9 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children and adolescents with a diagnosis of ADHD and control children without at diagnosis.

排除标准

  • Intellectual disability, psychosis, severe depression or anxiety

研究组 & 干预措施

Placebo medication and sham stimulation

Active Comparator

Patients will be randomly chosen to the group who will get a combination of placebo and sham stimulation.

干预措施: Sham stimulation (Device)

Active medication

Active Comparator

Patients are randomly chosen to the group who will get active medication without stimulation.

干预措施: Active medication (Drug)

Active stimulation

Sham Comparator

Patients are randomly chosen to the group who will get acitive stimulation without taking medicine.

干预措施: Stochastic Vestibular Stimulation (Device)

Controls with sham stimulation

Active Comparator

Controls without ADHD are randomly chosen to the group who will get sham stimulation.

干预措施: Sham stimulation (Device)

Controls with active stimulation

Sham Comparator

Controls without ADHD are randomly chosen to the group who will get active stimulation.

干预措施: Stochastic Vestibular Stimulation (Device)

结局指标

主要结局

Go No- go test

时间窗: Ten weeks

Test of impulse inhibition

Spanboard task

时间窗: Ten weeks

Test of visuo-spatial working memory

AVLT

时间窗: Ten weeks

Auditory Verbal Learning Test

次要结局

  • Soft- signs test(Ten weeks)
  • Finger tapping task(Ten weeks)
  • Flower trail(Ten weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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