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

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01560351
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pathological Gambling	Device: rTMS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rTMS Session of repeated low-frequency Transcranial Magnetic Stimulation	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.
Sham Comparator: Placebo Sessions of sham rTMS	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nantes	Nantes		France

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: Anne SAUVAGET, MD, Nantes UH

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT01560351
• Other Study ID Numbers: BRD/11/6-M
• First Posted: Mar 22, 2012
• Last Update Posted: Mar 10, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Nantes University Hospital: Pathological gambling; craving; repeated Transcranial Magnetic Stimulation; craving cues
• Additional relevant MeSH terms: Gambling

Study Results

No Results Posted as of Mar 10, 2015