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 January 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: January 7, 2014
Last verified: January 2014
  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:


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: November 2014
Estimated Primary Completion Date: November 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:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: January 7, 2014
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 July 28, 2014