Effect of rTMS in Pathological Gamblers

Pathological Gambler Clinical Trial

Official title:

Study of the Effect of an Active rTMS Session in Pathological Gamblers: Impact on Craving and Severity of These Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552524
• Other study ID #: 1201091
• Secondary ID: 2012-A01013-40
• Status: Completed
• Phase: N/A
• First received: September 11, 2015
• Last updated: June 3, 2016
• Start date: December 2013
• Est. completion date: June 2015

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pathological Gambler

Intervention

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
• 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

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing cue-induced craving	Scores on visual analog scales assessing craving just after a gambling video	After the session of rTMS (Day 2)	No
Secondary	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	No
Secondary	Cognitive tests	Reaction time and number of errors at Go-Nogo, Flexibility task and Iowa Gambling test	Day 2	No
Secondary	ANS activity	Indice HF, LF and LF/HF, heart rate; during gambling video	Day 2	No