NCT03826238|Unknown
VR Assessment for Alcohol Related Brain Damage
Alcohol Related Brain Damage: Exploring Virtual Reality Based Cognitive Function Assessment and EEG Biomarkers. A Pilot Study
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Alcohol Related Brain Damage: Exploring Virtual Reality Based Cognitive Function Assessment and EEG Biomarkers. A Pilot Study
Sponsor study identifier
observational
30
1 country
1
Study Start
May 1, 2021
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Primary Completion
November 30, 2021
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Study Completion
April 30, 2022
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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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 8, 2018
Actual (reported)February 1, 2019
Actual (reported)May 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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.
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.
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.
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.
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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.
Addictions Unit. Psychiatry and Psychology Service. Institut Clínic de Neurociències (ICN). Hospital Clínic de Barcelona. IDIBAPS
Barcelona, 08036, Spain
First Submitted
November 8, 2018
First Posted
February 1, 2019
Study Start
May 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 30, 2021
Melatonin Use for Sleep Problems in Alcohol Dependent Patients
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 3, 2021
Record last verified: 2021-04
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