Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2021-05-01
2022-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
Yes
Sponsors
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Hospital Clinic of Barcelona
OTHER
Institute for Bioengineering of Catalonia
OTHER
Universitat Pompeu Fabra
OTHER
Responsible Party
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Paul Verschure
Principal Investigator
Locations
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Addictions Unit. Psychiatry and Psychology Service. Institut Clínic de Neurociències (ICN). Hospital Clínic de Barcelona. IDIBAPS
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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REHABOH-VG
Identifier Type: -
Identifier Source: org_study_id
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