Ignite Creation Date:
2024-05-06 @ 8:58 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02862821
Status:
UNKNOWN
Last Update Posted:
2016-08-11
First Post:
2016-07-20
Brief Title:
Biomarkers of Online Gambling Addiction
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
Biomarkers of Online Gambling Addiction Biomarqueurs de la dépendance Aux Jeux dArgent en Ligne
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLUNDER
Brief Summary:
The purpose of this study is to identify alterations of motivational processes related to decision making in uncertainty condition associated with gambling addiction by studying the dynamics between brain systems involved in decision making and motivation
Detailed Description:
Internet gaming is a major risk for the vulnerable in terms of risk of dependence emergence of psychiatric disorders financial consequences and family Addictions to games in France represent 1 to 2 of the general population Online poker happens to be a specific form of gambling which has the fastest growing online games If vulnerabilities factors have been reported in many studies to date no biomarkers for screening people at risk are available
One of the favorite way in biomarker research concern impaired decision-making capacity biomarkers In a previous work investigators have shown that the decision was strongly linked to motivation and impaired decision-making capacity would be associated with a motivational dys-regulation Giustiniani et al 2015
The search for biomarkers in parallel to the motivation of the decision making is essential and yet this day nonexistent in the literature Here with subjects addicted to online poker a behavioral protocol developed to measure motivation in pathological populations Effort-Expenditure for Rewards Task EEfRT will be used and will be specifically adapted to be studied by functional neuroimaging
The main objective is to identify alterations of motivational processes related to decision making in conditions of uncertainty associated with gambling addiction For this purpose the dynamics between brain systems involved in decision making and motivation will be studied
As a secondary objective correlations between neural activity and performance to different tests used to measure decision making Iowa Gambling Task IGT and motivation EEfRT will be evaluated Finally the influence of motivation level on the performance score to decision making task will be evaluated the goal will be the development of an optimal strategy in terms of prevention
The study will be conducted at the University Hospital of Besancon during 36 months with 73 participants
The experiment will involve three stages
stage 1 validation of HR-EEG adaptated motivation EEfRT task adaptated to HR-EEG by 20 healthy volunteers
stage 2 identification of biomarkers by 20 addict online poker gamblers and 20 non-addict online poker gamblers
stage 3 validation of previously identified biomarkers by 13 online poker gamblers recruted in poker forum
All stages progress according to the same plan
Standardized questionnaire to define the socio-demographic data the diagnosis of gambling addiction ICJE criteria Indice Canadien fu Jeu Excessif screening for comorbidities addictive the level of anxiety and impulsivity
Registration of brain activity randomisation during the performance of a task of motivation evaluation laboratory EEfRT adaptated for high-resolution electroencephalography AND during a laboratory task that assesses decision making in conditions of uncertainty IGT with its version for high-resolution electroencephalography has already been validated in a previous study Giustiniani et al 2015
Statistical analysis will aim to compare the average activation differences between the two populations for each functional neuroimaging examination Then a subject-by-subject analysis of each brain activation will be conducted to look for correlations between the various examinations and strength of neuronal response
Following this study the results will allow us to identify biomarkers of addiction that will help improving vulnerable populations screening capabilities to tailor prevention strategies Furthermore the identification of specific neural correlates dependence will adapt therapeutic strategies
One of the favorite way in biomarker research concern impaired decision-making capacity biomarkers In a previous work investigators have shown that the decision was strongly linked to motivation and impaired decision-making capacity would be associated with a motivational dys-regulation Giustiniani et al 2015
The search for biomarkers in parallel to the motivation of the decision making is essential and yet this day nonexistent in the literature Here with subjects addicted to online poker a behavioral protocol developed to measure motivation in pathological populations Effort-Expenditure for Rewards Task EEfRT will be used and will be specifically adapted to be studied by functional neuroimaging
The main objective is to identify alterations of motivational processes related to decision making in conditions of uncertainty associated with gambling addiction For this purpose the dynamics between brain systems involved in decision making and motivation will be studied
As a secondary objective correlations between neural activity and performance to different tests used to measure decision making Iowa Gambling Task IGT and motivation EEfRT will be evaluated Finally the influence of motivation level on the performance score to decision making task will be evaluated the goal will be the development of an optimal strategy in terms of prevention
The study will be conducted at the University Hospital of Besancon during 36 months with 73 participants
The experiment will involve three stages
stage 1 validation of HR-EEG adaptated motivation EEfRT task adaptated to HR-EEG by 20 healthy volunteers
stage 2 identification of biomarkers by 20 addict online poker gamblers and 20 non-addict online poker gamblers
stage 3 validation of previously identified biomarkers by 13 online poker gamblers recruted in poker forum
All stages progress according to the same plan
Standardized questionnaire to define the socio-demographic data the diagnosis of gambling addiction ICJE criteria Indice Canadien fu Jeu Excessif screening for comorbidities addictive the level of anxiety and impulsivity
Registration of brain activity randomisation during the performance of a task of motivation evaluation laboratory EEfRT adaptated for high-resolution electroencephalography AND during a laboratory task that assesses decision making in conditions of uncertainty IGT with its version for high-resolution electroencephalography has already been validated in a previous study Giustiniani et al 2015
Statistical analysis will aim to compare the average activation differences between the two populations for each functional neuroimaging examination Then a subject-by-subject analysis of each brain activation will be conducted to look for correlations between the various examinations and strength of neuronal response
Following this study the results will allow us to identify biomarkers of addiction that will help improving vulnerable populations screening capabilities to tailor prevention strategies Furthermore the identification of specific neural correlates dependence will adapt therapeutic strategies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None