Clinical trial NCT03826238: VR Assessment for Alcohol Related Brain Damage
Official title: Alcohol Related Brain Damage: Exploring Virtual Reality Based Cognitive Function Assessment and EEG Biomarkers. A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcohol-Related Disorders
Keywords: alcohol-related brain damage
depression
attention
eeg
Lead sponsor: Universitat Pompeu Fabra
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Institute for Bioengineering of Catalonia
First posted: 2019-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ARBD (Groups A and B) will be consecutively recruited from the Addiction outpatient and Day Hospital Unit of Addiction Unit at the Department of Psychiatry at Hospital Clínic in Barcelona.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Virtual assessment (Validation Gate task)
timeFrame: 30 minutes
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 20 minutes
measure: Hamilton Depression Rating Scale
timeFrame: 10 minutes
Secondary outcomes:
measure: Resting State and task-dependent EEG
timeFrame: 40 minutes
measure: The alcohol, smoking and substance involvement screening test (ASSIST)
timeFrame: 10 minutes
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Addictions Unit. Psychiatry and Psychology Service. Institut Clínic de Neurociències (ICN). Hospital Clínic de Barcelona. IDIBAPS
Study officials:
References: