VR Assessment for Alcohol Related Brain Damage

NCT03826238 | Unknown

• 1 other identifier: REHABOH-VG
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol-Related Disorders

Keywords

alcohol-related brain damage; depression; attention; eeg

Outcome Measures

Primary Outcomes (3)

• Virtual assessment (Validation Gate task)

  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.

  30 minutes

• Montreal Cognitive Assessment (MoCA)

  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.

  20 minutes

• Hamilton Depression Rating Scale

  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)

  10 minutes

Secondary Outcomes (3)

• Resting State and task-dependent EEG

  40 minutes

• The alcohol, smoking and substance involvement screening test (ASSIST)

  10 minutes

• Alcohol Use Disorders Identification Test (AUDIT)

  10 minutes

Study Arms (3)

ARBD and depression

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.

Diagnostic Test: Validation Gate task

ARBD and no depression

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.

Diagnostic Test: Validation Gate task

Healthy

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.

Diagnostic Test: Validation Gate task

Interventions

Validation Gate task DIAGNOSTIC_TEST

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.

ARBD and depression; ARBD and no depression; Healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat Pompeu Fabra: lead
• Hospital Clinic of Barcelona: collaborator
• Institute for Bioengineering of Catalonia: collaborator

Study Sites (1)

Addictions Unit. Psychiatry and Psychology Service. Institut Clínic de Neurociències (ICN). Hospital Clínic de Barcelona. IDIBAPS

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Alcohol-Related Disorders; Depression

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Martina Maier, Ms

CONTACT

722257096; mmaier@ibecbarcelona.eu

Belén Rubio Ballester, PhD

CONTACT

rballester@ibecbarcelona.eu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: February 1, 2019
• Study Start: May 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: April 30, 2022
• Last Updated: May 3, 2021

Record last verified: 2021-04

Locations

ES (1)