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

Study Overview
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Brief Summary
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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).

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

Conditions
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Pathological Gambling

Intervention / Treatment
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* Device: rTMS


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS<br>Session of repeated low-frequency Transcranial Magnetic Stimulation | Device: rTMS<br>* 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.<br>|
| Sham Comparator: Placebo<br>Sessions of sham rTMS | Device: rTMS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pathological gambling, craving, repeated Transcranial Magnetic Stimulation, craving cues