Clinical trial NCT02552524: Effect of rTMS in Pathological Gamblers
Official title: Study of the Effect of an Active rTMS Session in Pathological Gamblers: Impact on Craving and Severity of These Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pathological Gambler
Keywords: pathological gambling
rTMS
cognitive tests
autonomic nervous system
craving
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessing cue-induced craving
timeFrame: After the session of rTMS (Day 2)
Secondary outcomes:
measure: Game behavior
timeFrame: Day 2
measure: Cognitive tests
timeFrame: Day 2
measure: ANS activity
timeFrame: Day 2
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Aurelia GAY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gay A, Boutet C, Sigaud T, Kamgoue A, Sevos J, Brunelin J, Massoubre C. A single session of repetitive transcranial magnetic stimulation of the prefrontal cortex reduces cue-induced craving in patients with gambling disorder. Eur Psychiatry. 2017 Mar;41:68-74. doi: 10.1016/j.eurpsy.2016.11.001. Epub 2017 Feb 3.