Skip to content

VR Assessment for Alcohol Related Brain Damage

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03826238
Enrollment
30
Registered
2019-02-01
Start date
2021-05-01
Completion date
2022-04-30
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol-Related Disorders

Keywords

alcohol-related brain damage, depression, attention, eeg

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.

Interventions

DIAGNOSTIC_TESTValidation Gate task

The task is to observe several moving unfilled white circles on a dark background. The circles move in straight paths. Every so often, a randomly selected circle will displace to a point inconsistent with its trajectory, which will look like a jump. The subjects' task is to press the space bar every time they detect a displacement (e.g. jump). A session consists of 30 minutes, it starts with 2 training blocks which are followed by 2 no-cognitive load blocks and 6 blocks with increasing cognitive load conditions. During the assessment the eye movement as well as the key presses are registered in order to calculate early and late saccades as well as conscious reporting. Resting-state EEG will also be recorded and compared to the ones of age-matched healthy controls. Task-dependent EEG data will be recorded during the Validation Gate task.

Sponsors

Hospital Clinic of Barcelona
CollaboratorOTHER
Institute for Bioengineering of Catalonia
CollaboratorOTHER
Universitat Pompeu Fabra
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Virtual assessment (Validation Gate task)30 minutesThe 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.
Montreal Cognitive Assessment (MoCA)20 minutesMoCA 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 Scale10 minutesEvaluation 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)

Secondary

MeasureTime frameDescription
Resting State and task-dependent EEG40 minutes6 minutes of EEG data during resting state and 30 minutes of EEG during the Validation Gate taks, will be acquired through the wireless sensor system ENOBIO32 of Starlab. From these recordings the mean spectral energy in the common frequency bands will be obtained as variables to identify signatures of TCD and the theta activity in the different groups.
The alcohol, smoking and substance involvement screening test (ASSIST)10 minutesThe ASSIST scale is used to detect substance use and classify risk and severity for each substance. Each question (8 questions) on the ASSIST has a set of responses to choose from, and each response has a numerical score (for instance they can range from 0 for never to up to 8 for daily). The interviewer simply circles the numerical score that corresponds to the patient's response for each question/substance. At the end of the interview the scores for each substance are added together to produce an ASSIST score for that substance. Low numbers mean low risk, high numbers mean high risk. We are testing only for Alcohol-Risk, which can have a risk-score from 0 to 31.
Alcohol Use Disorders Identification Test (AUDIT)10 minutesAssessment of alcohol use

Countries

Spain

Contacts

Primary ContactMartina Maier, Ms
mmaier@ibecbarcelona.eu722257096
Backup ContactBelén Rubio Ballester, PhD
rballester@ibecbarcelona.eu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026