Effect of rTMS in Pathological Gamblers

NCT ID: NCT02552524

Last Updated: 2016-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-06-30

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.

Conditions

Pathological Gambler

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

rTMS active then rTMS placebo

Intervention Type: DEVICE

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 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

Group Type: EXPERIMENTAL

rTMS placebo then rTMS active

Intervention Type: DEVICE

A 20 minute session of rTMS placebo then, 7 days later, a 20 minute session of rTMS at the frequency of 10 Hz

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aurelia GAY, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 28049084 (View on PubMed)

Other Identifiers

2012-A01013-40

Identifier Type: OTHER

Identifier Source: secondary_id

1201091

Identifier Type: -

Identifier Source: org_study_id