VR Assessment for Alcohol Related Brain Damage

Alcohol-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03826238
• Other study ID #: REHABOH-VG
• Status: Not yet recruiting
• Start date: May 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2021
• Source: Universitat Pompeu Fabra
• Contact: Martina Maier, Ms
• Phone: 722257096
• Email: mmaier[@]ibecbarcelona.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 30, 2022
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol-Related Disorders
• Brain Injuries

Intervention

Diagnostic Test:
• Validation 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.

Locations

Country	Name	City	State
Spain	Addictions Unit. Psychiatry and Psychology Service. Institut Clínic de Neurociències (ICN). Hospital Clínic de Barcelona. IDIBAPS	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Universitat Pompeu Fabra	Hospital Clinic of Barcelona, Institute for Bioengineering of Catalonia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Resting State and task-dependent EEG	6 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.	40 minutes
Secondary	The alcohol, smoking and substance involvement screening test (ASSIST)	The 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.	10 minutes
Secondary	Alcohol Use Disorders Identification Test (AUDIT)	Assessment of alcohol use	10 minutes