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临床试验/NCT03826238
NCT03826238Unknown不适用

Alcohol Related Brain Damage: Exploring Virtual Reality Based Cognitive Function Assessment and EEG Biomarkers. A Pilot Study

Universitat Pompeu Fabra1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Montreal Cognitive Assessment (MoCA)

研究概览

简要总结

Pilot study where 10 alcohol-related brain damage (ARBD) patients will undergo a 30-minutes-long cognitive assessment session using the Validation Gate task to evaluate usability of this tool in Alcohol Use Disorder patients. Resting-state EEG of ARBD patients will also be recorded and compared to the ones of age-matched healthy people in order to preliminary explore the existence of possible EEG biomarkers of ARBD.

详细描述

Much of the burden of disease related to harmful alcohol use is due to the persistent effects of alcohol on central nervous system. The concept of alcohol-related brain damage (ARBD) is important in the Addiction Psychiatry field. ARBD is a spectrum of disorders. Besides most severe forms, 50-70% of patients with alcohol use disorder suffer some kind of cognitive impairment, being mild to moderate cognitive impairment the most frequent disorders, and often the most difficult to detect. In alcoholic patients, greater cognitive impairment has been associated with less treatment compliance and fewer days of abstinence. Considering its impact, cognitive screening should be enhanced.

Recently, standard assessments have been augmented with new interactive technology. The work group of the Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), part of Institute for Bioengineering of Catalonia (IBEC), developed a virtual assessment of cognitive function, called the Validation Gate task, which evaluates sustained attention, working memory and executive functioning. This tool has been used so far in chronic stroke patients, showing that, in this group, depression symptoms affect performance in this task.

Similarly to chronic stroke patients, a diffuse harm of several cognitive domains in ARBD is observed. In the addiction psychiatry field, the gold standard to evaluate changes in cognitive function are still thorough neuropsychological test batteries. But performing thorough neuropsychological evaluations on all patients in daily clinical practice is highly resource consuming (need of expert neuropsychologists, time consuming). These last years scientific community has also been trying to find biomarkers of ARBD in electrophysiological tests, with no conclusive results.

In this pilot study a small number of ARBD patients and healthy people will undergo a single 30-minutes-long cognitive assessment session using the Validation Gate task to evaluate usability of this tool in Alcohol Use Disorder patients. Resting-state EEG of ARBD patients will also be recorded and compared to the ones of age-matched healthy controls in order to preliminary explore the existence of possible EEG biomarkers of ARBD.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

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

入选标准

  • Alcohol Use Disorder (DSM 5) as main substance
  • Positive screening for alcohol related cognitive impairment (Montreal Cognitive Assessment, MoCA < 26)
  • abstinent during 15 to 90 days according to self-reports
  • no severe upper limb motor disability.
  • Older than 18 years old.
  • abìlity to talk, understand and write in Catalan, Spanish or English.
  • sign informed consent

排除标准

  • severe cognitive incapacity that prohibits the execution of the assessment
  • severe impairments like spasticity, communication disabilities (aphasia or apraxia) and perceptual or physical impairments that would interfere with the correct execution or understanding of the assessment
  • history of other serious mental-health problems in acute or subacute phase
  • comorbidity with severe neurological illness
  • regular use of other substances (except nicotine)
  • active intake of benzodiazepines

结局指标

主要结局

Montreal Cognitive Assessment (MoCA)

时间窗: 20 minutes

MoCA test is a screening test for cognitive impairment that explores 8 domains: visuospatial/executive ability, naming, memory, attention, language, abstraction, delayed recall, and orientation.

Hamilton Depression Rating Scale

时间窗: 10 minutes

Evaluation tool of depression. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The summed score indicates severity (0-7 no depression, \> 23 very severe depression)

Virtual assessment (Validation Gate task)

时间窗: 30 minutes

The Validation Gate task, a visual attention task where the patient must detect discontinuities in the moving trajectory of circles on the screen. In this task the following variables will be registered: fast and slow eye saccades as well as conscious detections.

次要结局

  • The alcohol, smoking and substance involvement screening test (ASSIST)(10 minutes)
  • Resting State and task-dependent EEG(40 minutes)
  • Alcohol Use Disorders Identification Test (AUDIT)(10 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Verschure

Principal Investigator

Universitat Pompeu Fabra

研究点 (1)

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