Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study

Nantes University Hospital31 enrolled

Overview

The aim of this study is to evaluate the effect of repeated low-frequency Transcranial Magnetic Stimulation (rTMS) of the right dorsolateral prefrontal cortex, combined with gambling cues, on gambling craving. Participants are pathological gamblers. A single real stimulation and a single shame stimulation are administered in a random order for each participant (cross-over study).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pathological Gambling

Interventions

rTMSDEVICE

Two sessions of repeated Transcranial Magnetic Stimulation (real rTMS and sham rTMS) are planned for each participant, at interval of 4 weeks, in a random order.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria: * Pathological gambler (DSM-IV criteria) * Seeking treatment at the University Hospital of Nantes * Right-handed * 18-65 years old * Increase in the intensity (at least 50%) of the gambling craving with gambling cues Non-inclusion criteria: * pregnant woman * no effective contraception * Substance use disorders (excluding nicotine) * Benzodiazepine use * Chronic neurological disease * History of head injury * History of neurosurgery * Cochlear implant or other metal objects in the head * History of Transcranial Magnetic Stimulation or repeated Transcranial * Magnetic Stimulation * Difficult to read or write French Exclusion criteria: * Occurrence of side effects (like seizures) * Psychoactive substance use 12 hours before the rTMS (excluding nicotine)

Locations (1)

Nantes

Nantes, France

Outcomes

Primary Outcomes

Visual Analogue Scale (VAS)

Cue-induced craving is evaluated using a VAS, immediately before and immediately after the administration of the craving cues, and immediately after the rTMS session (real and sham).

Secondary Outcomes

Visual Analogue Scale (VAS)

Cue-induced craving kinetics : cue-induced craving is evaluated using a VAS every 5 minutes until its intensity returns to baseline.

Gambling Craving Scale (GACS)

Cue-induced craving is also evaluated using the GACS, immediately before and immediately after the administration of the craving cues, immediately after the rTMS session, and every 5 minutes until its intensity returns to baseline.

blood pressure

Cue-induced craving is also evaluated using the measure of the blood pressure, immediately before and immediately after the administration of the craving cues, immediately after the rTMS session, and every 5 minutes until its intensity returns to baseline.

heart rate

Cue-induced craving is also evaluated using the measure of the heart rate, immediately before and immediately after the administration of the craving cues, immediately after the rTMS session, and every 5 minutes until its intensity returns to baseline.

Data from ClinicalTrials.gov

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