Effect of rTMS in Pathological Gamblers

Not Applicable

Completed

• Conditions: Pathological Gambler
• Interventions: Device: rTMS placebo then rTMS active; Device: rTMS active then rTMS placebo

• Registration Number: NCT02552524
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study Start: 2013-12
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-09-11
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-03
• Last Update Posted: 2016-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
rTMS placebo then rTMS active	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
rTMS active then rTMS placebo	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.

Primary Outcome Measures

Name	Time	Method
Assessing cue-induced craving	After the session of rTMS (Day 2)	Scores on visual analog scales assessing craving just after a gambling video

Secondary Outcome Measures

Name	Time	Method
Game behavior	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
Cognitive tests	Day 2	Reaction time and number of errors at Go-Nogo, Flexibility task and Iowa Gambling test
ANS activity	Day 2	Indice HF, LF and LF/HF, heart rate; during gambling video

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France