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).
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Saint-etienne, Francia, 42000
- CHU de Saint-Etienne
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Sperimentale: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assessing cue-induced craving
Lasso di tempo: After the session of rTMS (Day 2)
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Scores on visual analog scales assessing craving just after a gambling video
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After the session of rTMS (Day 2)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Game behavior
Lasso di tempo: Day 2
|
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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Aurélia GAY, MD, CHU de Saint-Etienne
Pubblicazioni e link utili
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 1201091
- 2012-A01013-40 (Altro identificatore: ANSM)
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