Transcranial Magnetic Stimulation and Bulimic Craving

Bulimia Clinical Trial

Official title:

Transcranial Magnetic Stimulation, Embodied Cognition and Bulimic Craving

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547246
• Other study ID #: 1108053
• Secondary ID: 2011-A00481-40
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: March 22, 2016
• Start date: January 2012
• Est. completion date: July 2014

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: French Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Bulimia

Intervention

Device:
• rTMS session
One session of rTMS at a frequency of 10 Hz during 20 minutes
• rTMS Placebo (SHAM)
One session of placebo (SHAM) rTMS during 20 minutes

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor response time	time taken to pull or push the lever in cognitive tests (composite measure)	24h after rTMS session	Yes