ClinicalTrials.Veeva

Menu

VR Assessment for Alcohol Related Brain Damage

U

Universitat Pompeu Fabra

Status

Unknown

Conditions

Alcohol-Related Disorders

Treatments

Diagnostic Test: Validation Gate task

Study type

Observational

Funder types

Other

Identifiers

NCT03826238
REHABOH-VG

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

ARBD and depression
Description:
10 patients with ARBD and at least moderate depressive symptoms (MoCA \< 26, Hamilton Depression Rating Scale ≥ 17). Intervention: The Validation Gate task, a visual attention task where the subject must detect discontinuities in the moving trajectory of circles on the screen while EEG is recorded.
Treatment:
Diagnostic Test: Validation Gate task
ARBD and no depression
Description:
10 patients with ARBD and no clinically relevant depressive symptoms (MoCA \< 26, Hamilton Depression Rating Scale \< 17). Intervention: The Validation Gate task, a visual attention task where the subject must detect discontinuities in the moving trajectory of circles on the screen while EEG is recorded.
Treatment:
Diagnostic Test: Validation Gate task
Healthy
Description:
10 healthy controls (no ARDB, no depression, no cognitive deficit). Intervention: The Validation Gate task, a visual attention task where the subject must detect discontinuities in the moving trajectory of circles on the screen while EEG is recorded.
Treatment:
Diagnostic Test: Validation Gate task

Trial contacts and locations

1

Loading...

Central trial contact

Martina Maier, Ms; Belén Rubio Ballester, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems