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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)

Primary Purpose

Pathological Gambling

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rTMS
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pathological Gambling focused on measuring Pathological gambling, craving, repeated Transcranial Magnetic Stimulation, craving cues

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Nantes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

rTMS

Placebo

Arm Description

Session of repeated low-frequency Transcranial Magnetic Stimulation

Sessions of sham rTMS

Outcomes

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.

Full Information

First Posted
March 19, 2012
Last Updated
March 9, 2015
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01560351
Brief Title
Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study
Acronym
STIMJEU
Official Title
Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Study Start Date
March 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pathological Gambling
Keywords
Pathological gambling, craving, repeated Transcranial Magnetic Stimulation, craving cues

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS
Arm Type
Experimental
Arm Description
Session of repeated low-frequency Transcranial Magnetic Stimulation
Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
Sessions of sham rTMS
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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 Measure Information:
Title
Visual Analogue Scale (VAS)
Description
Cue-induced craving kinetics : cue-induced craving is evaluated using a VAS every 5 minutes until its intensity returns to baseline.
Title
Gambling Craving Scale (GACS)
Description
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.
Title
blood pressure
Description
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.
Title
heart rate
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne SAUVAGET, MD
Organizational Affiliation
Nantes UH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nantes
City
Nantes
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.crje.fr
Description
Click here for more information about this study and about excessive gambling

Learn more about this trial

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

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