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).

Study Overview

• Status: Completed
• Conditions: Pathological Gambler
• Intervention / Treatment: Device: rTMS active then rTMS placebo; Device: rTMS placebo then rTMS active

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • Chu de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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
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	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Aurélia GAY, MD, Chu de Saint-Etienne

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 11, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Estimate): June 6, 2016
• Last Update Submitted That Met QC Criteria: June 3, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: craving; autonomic nervous system; rTMS; cognitive tests; pathological gambling
• Other Study ID Numbers: 1201091; 2012-A01013-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO