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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Saint-etienne, Francia, 42000
- CHU de Saint-Etienne
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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
|
|
Experimental: 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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Assessing cue-induced craving
Periodo de tiempo: 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)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Game behavior
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Aurélia GAY, MD, CHU de Saint-Etienne
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 1201091
- 2012-A01013-40 (Otro identificador: ANSM)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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