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. (see Contacts and Locations)
Verified September 2014 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01560351
First received: March 19, 2012
Last updated: September 25, 2014
Last verified: September 2014

March 19, 2012
September 25, 2014
March 2012
January 2015   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01560351 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study
Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pathological Gambling
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.
  • Experimental: rTMS
    Session of repeated low-frequency Transcranial Magnetic Stimulation
    Intervention: Device: rTMS
  • Sham Comparator: Placebo
    Sessions of sham rTMS
    Intervention: Device: rTMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
January 2015
January 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years to 65 Years
No
Contact: Marie GRALL - BRONNEC, MD marie.bronnec@chu-nantes.fr
France
 
NCT01560351
BRD/11/6-M
No
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Anne SAUVAGET, MD Nantes UH
Nantes University Hospital
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP