CClinicalTrials.gg
Status unknownNCT02862821BLUNDERUpdated Aug 11, 2016

Biomarkers of Online Gambling Addiction

An interventional study of HR-EEG in Gambling, sponsored by Centre Hospitalier Universitaire de Besancon. Status unknown. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-11.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
73
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Gambling

Keywords

  • biomarkers of psychiatric disorder
  • gambling addiction
  • high resolution-ElectroEncephaloGraphy (HR-EEG)
03

In context

Behavior, Addictive

540 studies on the registry are indexed under Behavior, Addictive; 134 are open to participants now.

This study's planned enrollment of 73 is close to the median of 72 across 391 interventional studies indexed under Behavior, Addictive.

Browse Behavior, Addictive studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • right-handed
  • stage 1: healthy volunteers (no online poker gamblers and no-addict (excepted tobacco and caffeine))
  • stage 2 : 20 addict-online pokers gamblers and 20 non addict online pokers gamblers (according to ICJE criteria)
  • stage 3 : 13 online poker gamblers (independently of their dependence level)

Exclusion criteria

Exclusion Criteria:

  • left-handed
  • female
  • stage 1 and 2: other addictive pathology excepted tobacco and caffeine
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
73 participants (estimated)

Study arms

  • Experimental
    validation of EEfRT task

    20 healthy volunteers will be recruted to validate motivation EEfRT task which is adaptated to HR-EEG

    Other: HR-EEG

  • Experimental
    biomarkers identification

    20 addict online poker gamblers and 20 non-addict online poker gamblers will be recruted : After standardized questionnaires to define the socio-demographic data, the diagnosis of gambling addiction (Diagnostic and Statistical Manual of Mental Disorder 5th edition DSM-5), screening for comorbidities addictive, the level of anxiety and impulsivity, brain acvtivity will be registred (by randomisation between the 2 tasks) with HR-EEG: 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).

    Other: HR-EEG

  • Experimental
    biomarkers validation

    13 online poker gamblers will be recruted, independently of their dependance profile and they will realize the same task that in precedent arm (quaestionnaires and 2 tasks adaptated to HR-EEG).

    Other: HR-EEG

Interventions

  • OtherHR-EEG
06

What researchers measure

Primary outcomes

  1. average activation for each functional neuroimaging examination

    Time frame: day 7 ; day 14

Secondary outcomes

  1. correlations between various examinations and strength of neuronal response

    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.

    Time frame: day 7 ; day 14

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Giustiniani J, Gabriel D, Nicolier M, Monnin J, Haffen E. Neural Correlates of Successful and Unsuccessful Strategical Mechanisms Involved in Uncertain Decision-Making. PLoS One. 2015 Jun 18;10(6):e0130871. doi: 10.1371/journal.pone.0130871. eCollection 2015. PubMed 26086196 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02862821
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Aug 11, 2016
Start date
Sep 2016
Primary completion
Jul 2019 (estimated)
Completion
Jul 2019 (estimated)
Last update
Aug 11, 2016

Study contacts

Julie GIUSTINIANI, MD
Contact
jgiustiniani@chu-besancon.fr
+33381219007
Magali NICOLIER, PhD
Contact
mnicolier@chu-besancon.fr
+33381219007
Julie GIUSTINIANI, MD
principal investigator · University Hospital of Besancon

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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