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

Not Applicable

Terminated

• Conditions: Pathological Gambling
• Interventions: Device: rTMS

• Registration Number: NCT01560351
• Lead Sponsor: Nantes University Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-19
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
rTMS	rTMS	Session of repeated low-frequency Transcranial Magnetic Stimulation
Placebo	rTMS	Sessions of sham rTMS

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Nantes; 🇫🇷 Nantes, France