Transcranial Magnetic Stimulation and Bulimic Craving
2 other identifiers
interventional
30
1 country
1
Brief Summary
Bulimic patients suffering from binge eating or "craving" a pressing need to eat, with a sense of unease and anxiety, relieved by food intake. The phenomenon of craving bulimia may be considered appropriately by using paradigms developed in the framework of embodied cognition theories. In bulimic, a study with 20 bulimic patients proved an automatic attraction (unconscious) for food in these patients, as measured by reaction time. Moreover, a therapeutic explored in bulimia (particularly on reducing craving), is repeated transcranial magnetic stimulation (rTMS). Studies have shown that a single session of rTMS to the dorsolateral prefrontal cortex left (DLPFC) reduces significantly the food craving among bulimics, 24 hours after stimulation. But the therapeutic efficacy of TMS on bulimia to more than 24 hours has not yet been demonstrated, and the psycho-cognitive underlying mechanisms have not yet been explored.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 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
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 9, 2015
CompletedFirst Posted
Study publicly available on registry
September 11, 2015
CompletedMarch 23, 2016
March 1, 2016
2.5 years
September 9, 2015
March 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Motor response time
time taken to pull or push the lever in cognitive tests (composite measure)
24h after rTMS session
Study Arms (2)
rTMS session
EXPERIMENTALPatients will have a 20 minute session of rTMS at a frequency of 10 Hz.
rTMS placebo (SHAM) session
PLACEBO COMPARATORPatients will have a 20 minute session of placebo rTMS
Interventions
One session of placebo (SHAM) rTMS during 20 minutes
Eligibility Criteria
You may qualify if:
- right-handed patient
- Patients without psychotropic treatment or treatment with a stable and unchanged for over a month.
- Normal BMI
You may not qualify if:
- Previous history of seizures or epilepsy.
- Participants with a somatic problem restricted movement or an uncorrected visual acuity problem.
- History of head trauma, neurological disease or unstabilized serious physical illness.
- Major Depressive Episode at the time of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de SAINT-ETIENNE
Saint-Etienne, 42000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Torrance SIGAUD, MD
CHU de SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2015
First Posted
September 11, 2015
Study Start
January 1, 2012
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
March 23, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share