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临床试验/NCT03255837
NCT03255837已完成不适用

A Single Blind, Randomized Controlled Trial of Anodal Transcranial Direct-current Stimulation (tDCS) Against Cathodal and Sham Stimulation in Adults With High-Functioning Autism

NHS Greater Glasgow and Clyde1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年2月26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
50
试验地点
1
主要终点
Working memory accuracy score compared to typically developed controls scores.

研究概览

简要总结

This study will involve an experiment in individuals with Autism Spectrum Disorder (ASD) comparing their performance on a working memory task before, during and after non-invasive brain stimulation (tDCS) compared to a control group in a 3x3 factorial design. How the stimulation affects performance on the task will be assessed, along with the impact of the intervention on the individuals.

详细描述

Many studies have examined working memory in people with autism spectrum disorder as working memory deficits in individuals with autism spectrum disorder leads to multiple difficulties associated with behaviour regulation, cognitive flexibility, abstract thinking, and focusing and sustaining attention. Evidence suggests that transcranial Direct Current Stimulation on the left dorsolateral prefrontal cortex leads to an increase in working memory performance in typically developing individuals. This may have important benefits for people with autism spectrum disorder since autism spectrum disorder is known to be associated with working memory deficiencies. This study will build on a pilot study conducted in 2014, the experiment tested participants working memory scores on an N-back test, after receiving anodal (positive stimulation) stimulation for 15 minutes over the left dorsolateral prefrontal cortex. This task requires the participant to perform multiple cognitive operations, including encoding of new stimuli, updating and maintaining past stimuli, and recognising and responding to whether each new stimulus matches the three-back stimulus. Participants are presented with a random set of ten letters (from A-Z). A different letter will be displayed every 2s, participants will be required to respond (key press 1) if the presented letter was the same as the letter presented three stimuli previously (a target). If it was not a target, participants were required to respond with key press 2. In this test, a total of 30 correct responses are possible. Participants will perform the task three times to reduce variability. Accuracy (number of correct responses), error rate (number of incorrect responses), and reaction time (interval between target presentation and pressing 1 or 2) will be recorded. Based on the findings from the pilot study, a full study will be conducted to investigate the effects of anodal transcranial Direct Current Stimulation on adults with high-functioning autism, as well as test whether the effects of transcranial Direct Current Stimulation on dorsolateral prefrontal cortex is dependent on polarity (anodal versus cathodal (negative stimulation) stimulation).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Participants will be unaware of the order in which they receive the transcranial stimulation condition (anodal, cathodal, sham).

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • clinical diagnosis of ASD
  • right handed
  • speaks English fluently
  • normal vision or corrected to normal
  • passing tDCS safety screening

排除标准

  • participants who do not understand verbal or written English (i.e would be in need of translators)
  • participants that have ever suffered from epilepsy, febrile convulsions in infancy or had recurrent fainting spells
  • family history of epilepsy
  • has a heart pacemaker, cochlear implant, medication pump, surgical clips
  • has drunk more than 3 units of alcohol in the last 24 hours
  • suffers from migraines
  • metal in the head, implanted brain medical devices
  • has undergone a neurosurgical procedure
  • has had more than one cup of coffee, or other sources of caffeine in the last hour
  • taking any unprescribed or prescribed medication that might effect tDCS
  • medications or psychoactive drugs that can lower seizure threshold [imipramine, amitriptyline, doxepine, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, amphetamines, cocaine, (MDMA, ecstasy), phencyclidine (PCP, angel dust), ketamine, gamma-hydroxybutyrate (GHB), alcohol, theophylline]
  • withdrawal from alcohol, barbiturates, benzodiazepines, meprobamate, chloral hydrate

研究组 & 干预措施

Transcranial direct current stimulation (tDCS) - anodal

Experimental

Transcranial direct current stimulation - anodal (positive) 1.5 millamps for 15 minutes

干预措施: Transcranial direct current stimulation (tDCS) (Device)

Transcranial direct current stimulation (tDCS) - cathodal

Experimental

Transcranial direct current stimulation - cathodal (negative) 1.5 millamps for 15 minutes

干预措施: Transcranial direct current stimulation (tDCS) (Device)

Transcranial direct current stimulation (tDCS) - sham

Sham Comparator

Transcranial direct current stimulation - sham session 15 minutes

干预措施: Transcranial direct current stimulation (tDCS) (Device)

结局指标

主要结局

Working memory accuracy score compared to typically developed controls scores.

时间窗: Change from baseline (before stimulation) to after stimulation (1 week)

Result of N-back memory task

次要结局

  • Difference in working memory accuracy score between adults with ASD and healthy controls(After stimulation (1 week))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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tDCS on Working Memory (WM) in Adults With ASD | 临床试验