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

This study is currently recruiting participants.
Verified February 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01560351
First received: March 19, 2012
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention
Pathological Gambling
 Device: rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Visual Analogue Scale (VAS) [ Designated as safety issue: No ]
    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:
  • Visual Analogue Scale (VAS) [ Designated as safety issue: No ]
    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) [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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 [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 42
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Pathological gambler (DSM-IV criteria)
  • Seeking treatment at the University Hospital of Nantes
  • Men
  • Right-handed
  • 18-65 years old
  • Increase in the intensity (at least 50%) of the gambling craving with gambling cues

Non-inclusion criteria:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01560351

Contacts
Contact: Marie GRALL - BRONNEC, MD marie.bronnec@chu-nantes.fr

Locations
France
Nantes Recruiting
Nantes, France
Contact: Marie GRALL - BRONNEC, MD         marie.bronnec@chu-nantes.fr    
Principal Investigator: Anne SAUVAGET, MD            
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Anne SAUVAGET, MD Nantes UH
  More Information

Additional Information:
Click here for more information about this study and about excessive gambling  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01560351     History of Changes
Other Study ID Numbers: BRD/11/6-M
Study First Received: March 19, 2012
Last Updated: February 6, 2013
Health Authority: France : Agence Française de Sécurité Sanitaire des Produits de Santé

Keywords provided by Nantes University Hospital:
Pathological gambling
craving
repeated Transcranial Magnetic Stimulation
craving cues

Additional relevant MeSH terms:
Gambling
Impulse Control Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013