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

Pathological Gambling Clinical Trial

— STIMJEU  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01560351
• Other study ID #: BRD/11/6-M
• Status: Terminated
• Phase: N/A
• First received: March 19, 2012
• Last updated: March 9, 2015
• Start date: March 2012
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : Agence Française de Sécurité Sanitaire des Produits de Santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gambling
• Pathological Gambling

Intervention

Device:
• rTMS
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.

Locations

Country	Name	City	State
France	Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		No
Secondary	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.		No
Secondary	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.		No
Secondary	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.		No
Secondary	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.		No

External Links

•   Click here for more information about this study and about excessive gambling