Trials / Completed
CompletedNCT02552524
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 |
| DEVICE | rTMS placebo then rTMS active | A 20 minute session of rTMS placebo then, 7 days later, a 20 minute session of rTMS at the frequency of 10 Hz |
Timeline
- Start date
- 2013-12-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2015-09-17
- Last updated
- 2016-06-06
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02552524. Inclusion in this directory is not an endorsement.