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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02552524
Enrollment
22
Registered
2015-09-17
Start date
2013-12-31
Completion date
2015-06-30
Last updated
2016-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pathological Gambler

Keywords

pathological gambling, rTMS, cognitive tests, autonomic nervous system, craving

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.

Interventions

DEVICErTMS 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

DEVICErTMS 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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessing cue-induced cravingAfter the session of rTMS (Day 2)Scores on visual analog scales assessing craving just after a gambling video

Secondary

MeasureTime frameDescription
Game behaviorDay 2Scores 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 testsDay 2Reaction time and number of errors at Go-Nogo, Flexibility task and Iowa Gambling test
ANS activityDay 2Indice HF, LF and LF/HF, heart rate; during gambling video

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026