Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study
STIMJEU
1 other identifier
interventional
31
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 19, 2012
CompletedFirst Posted
Study publicly available on registry
March 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedMarch 10, 2015
March 1, 2015
2.8 years
March 19, 2012
March 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Visual Analogue Scale (VAS)
Gambling Craving Scale (GACS)
blood pressure
heart rate
Study Arms (2)
rTMS
EXPERIMENTALSession of repeated low-frequency Transcranial Magnetic Stimulation
Placebo
SHAM COMPARATORSessions of sham rTMS
Interventions
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 Criteria
You may qualify if:
- Pathological gambler (DSM-IV criteria)
- Seeking treatment at the University Hospital of Nantes
- Right-handed
- years old
- Increase in the intensity (at least 50%) of the gambling craving with gambling cues
- 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
- +1 more criteria
You may not qualify if:
- Occurrence of side effects (like seizures)
- Psychoactive substance use 12 hours before the rTMS (excluding nicotine)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nantes
Nantes, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne SAUVAGET, MD
Nantes UH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2012
First Posted
March 22, 2012
Study Start
March 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
March 10, 2015
Record last verified: 2015-03