- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01560351
Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study (STIMJEU)
March 9, 2015 updated by: Nantes University Hospital
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nantes, France
- Nantes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: rTMS
Session of repeated low-frequency Transcranial Magnetic Stimulation
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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.
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SHAM_COMPARATOR: Placebo
Sessions of sham rTMS
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Visual Analogue Scale (VAS)
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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).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Visual Analogue Scale (VAS)
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Cue-induced craving kinetics : cue-induced craving is evaluated using a VAS every 5 minutes until its intensity returns to baseline.
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Gambling Craving Scale (GACS)
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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.
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blood pressure
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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.
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heart rate
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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.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne SAUVAGET, MD, Nantes UH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (ACTUAL)
January 1, 2015
Study Completion (ACTUAL)
January 1, 2015
Study Registration Dates
First Submitted
March 19, 2012
First Submitted That Met QC Criteria
March 21, 2012
First Posted (ESTIMATE)
March 22, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
March 10, 2015
Last Update Submitted That Met QC Criteria
March 9, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BRD/11/6-M
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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