Transcranial Magnetic Stimulation and Bulimic Craving

NCT ID: NCT02547246

Last Updated: 2016-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-07-31

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.

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

Conditions

Bulimia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

rTMS session

Patients will have a 20 minute session of rTMS at a frequency of 10 Hz.

Group Type: EXPERIMENTAL

rTMS session

Intervention Type: DEVICE

One session of rTMS at a frequency of 10 Hz during 20 minutes

rTMS placebo (SHAM) session

Patients will have a 20 minute session of placebo rTMS

Group Type: PLACEBO_COMPARATOR

rTMS Placebo (SHAM)

Intervention Type: DEVICE

One session of placebo (SHAM) rTMS during 20 minutes

Interventions

rTMS session

One session of rTMS at a frequency of 10 Hz during 20 minutes

Intervention Type: DEVICE

rTMS Placebo (SHAM)

One session of placebo (SHAM) rTMS during 20 minutes

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Torrance SIGAUD, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Countries

France

Other Identifiers

2011-A00481-40

Identifier Type: OTHER

Identifier Source: secondary_id

1108053

Identifier Type: -

Identifier Source: org_study_id