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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 has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01560351
First Posted: March 22, 2012
Last Update Posted: March 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nantes University Hospital
  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
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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 31
Study Start Date: March 2012
Study Completion Date: January 2015
Primary Completion Date: January 2015 (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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560351


Locations
France
Nantes
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Anne SAUVAGET, MD Nantes UH
  More Information

Additional Information:
Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01560351     History of Changes
Other Study ID Numbers: BRD/11/6-M
First Submitted: March 19, 2012
First Posted: March 22, 2012
Last Update Posted: March 10, 2015
Last Verified: March 2015

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

Additional relevant MeSH terms:
Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders