- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02547246
Transcranial Magnetic Stimulation and Bulimic Craving
Transcranial Magnetic Stimulation, Embodied Cognition and Bulimic Craving
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The exams / treatments of the study include:
- a 20 minute session of rTMS at a frequency of 10 Hz.
- cognitive testing and attention, which will be made on the computer before and 24 hours after the session of rTMS.
Cognitive test consist in , on a computer screen:
- Is first displayed, food and non-food words. The patient must pull a lever to it if the letter A is present in the word and push the lever if the letter A is missing the word.
- Then presents a series of food and non-food words. The patient must pull a lever to it if it deems that the word has a positive meaning and push the lever if it determines that the word has a negative meaning
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Saint-etienne, France, 42000
- CHU de Saint-Etienne
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- right-handed patient
- Patients without psychotropic treatment or treatment with a stable and unchanged for over a month.
- Normal BMI
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: rTMS session
Patients will have a 20 minute session of rTMS at a frequency of 10 Hz.
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One session of rTMS at a frequency of 10 Hz during 20 minutes
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Placebo Comparator: rTMS placebo (SHAM) session
Patients will have a 20 minute session of placebo rTMS
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One session of placebo (SHAM) rTMS during 20 minutes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor response time
Time Frame: 24h after rTMS session
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time taken to pull or push the lever in cognitive tests (composite measure)
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24h after rTMS session
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Collaborators and Investigators
Investigators
- Principal Investigator: Torrance SIGAUD, MD, CHU de Saint-Etienne
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1108053
- 2011-A00481-40 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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Clinical Trials on rTMS session
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