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Completed

NCT Number: NCT02552524

Effect of rTMS in Pathological Gamblers

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTMS active then rTMS placebo

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

Device

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

Primary outcomes

  1. Assessing cue-induced craving

    Time frame: After the session of rTMS (Day 2)

    Scores on visual analog scales assessing craving just after a gambling video

Secondary outcomes

  1. Game behavior

    Time frame: 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

  2. Cognitive tests

    Time frame: Day 2

    Reaction time and number of errors at Go-Nogo, Flexibility task and Iowa Gambling test

  3. ANS activity

    Time frame: Day 2

    Indice HF, LF and LF/HF, heart rate; during gambling video

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2015
Registry last updated
Jun 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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