Effect of rTMS in Pathological Gamblers
Study of the Effect of an Active rTMS Session in Pathological Gamblers: Impact on Craving and Severity of These Behaviors
The gambling problem is characterized by a loss of control and an excessive focus on the gambling practice. Currently, the treatment of pathological gamblers is often complex and multidimensional, it notably includes psychological techniques including cognitive behavioral therapy and the use of psychotropic drugs.
In pathological gambling and addictions, craving (or urge to play) and loss of control are two essential clinical elements. The neurobiological level, they are associated with a dysfunction of dorsolateral prefrontal cortex (DLPFC) (Goldstein et al, 2001, Volkow and Goldstein, 2002).
One therapeutic avenues explored in addictions is repeated transcranial magnetic stimulation (rTMS).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Patients included in this study will have:
- An anatomical brain MRI (30 minutes).
- Two 20 minute sessions of rTMS (placebo and active) of the left DLPFC, at the frequency of 10 Hz.
- Visual Analogue Scale measuring their desire to gamble before and after a gambling video and test measuring their gambling behavior during the last 7 days (PG-YBOCS).
- Cognitive tests, to be carried out on a computer before and immediately after rTMS sessions.
- Recording heart rate variability (HRV) to measure the autonomic nervous system (ANS) activity
As it is a pilot study, the investigators don't have sufficient data to calculate statistical power and number of participants. The investigators based on previous studies evaluating one rTMS session on craving in SUD and used a crossover design to generate greater power.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Saint-etienne, France, 42000
- CHU de Saint-Etienne
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Patients with a diagnosis of pathological gambling (DSM IV criteria)
- First-time consultants.
- Without psychotropic treatment or treatment with a stable and unchanged for over a month.
Exclusion Criteria:
- Presence of ferromagnetic material or devices implanted neurostimulation in close contact with the coil
- Pregnant women and patients with hearing disorders
- Personal history of epilepsy (untreated or poorly balanced)
- Focal brain injury, whatever its origin (vascular, traumatic, tumor or infectious)
- History of head trauma with loss of consciousness,
- Administration of drugs or substances lowering the seizure threshold
- Sleep deprivation, jet lag, or drug withdrawal.
- Participants with a problem of uncorrected visual acuity.
- Other current addiction (except tobacco, for reasons of feasibility).
- Current Psychiatric comorbidity
- Treatment psychotropic introduced or changed for less than a month.
- Subjects with atrial fibrillation, with a pacemaker and / or receiving antiarrhythmic drugs
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: rTMS active then rTMS placebo
A 20 minute session of rTMS active at the frequency of 10 Hz then, 7 days later, a 20 minute session of rTMS placebo (rTMS active then rTMS placebo). Patient will also have cognitive tests before and after rTMS session and HRV recording during visit. |
A 20 minute session of rTMS active at the frequency of 10 Hz then, 7 days later, a 20 minute session of rTMS placebo
|
|
Expérimental: rTMS placebo then rTMS active
A 20 minute session of rTMS placebo then, 7 days later, a 20 minute session of rTMS active at the frequency of 10 Hz (rTMS placebo then rTMS active). Patient will also have cognitive tests before and after rTMS session and HRV recording during visit |
A 20 minute session of rTMS placebo then, 7 days later, a 20 minute session of rTMS at the frequency of 10 Hz
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Assessing cue-induced craving
Délai: After the session of rTMS (Day 2)
|
Scores on visual analog scales assessing craving just after a gambling video
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After the session of rTMS (Day 2)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Game behavior
Délai: Day 2
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Scores at the PG-YBOCS (obsessions-compulsions scale Yale-Brown (Y-BOCS), adapted for pathological gambling) (PG-YBOCS) (Pallanti et al., 2005)) assessing the severity of gambling behavior over the past week
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Day 2
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Cognitive tests
Délai: Day 2
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Reaction time and number of errors at Go-Nogo, Flexibility task and Iowa Gambling test
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Day 2
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ANS activity
Délai: Day 2
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Indice HF, LF and LF/HF, heart rate; during gambling video
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Day 2
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Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Aurélia GAY, MD, CHU de Saint-Etienne
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 1201091
- 2012-A01013-40 (Autre identifiant: ANSM)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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