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Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) in Bulimia (rTMS & bulimia)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University Hospital, Montpellier.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Centre Hospitalier Universitaire de Saint Etienne
University Hospital, Marseille
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01530906
First received: February 1, 2012
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

Bulimia nervosa is defined by recurrent episodes of binge eating followed by compensatory behaviors (such as induced vomiting) to prevent weight gain. It is a common and serious disease for which current treatment strategies have to be improved.

The aim of this study is to assess whether a transcranial magnetic stimulation reduces bulimic symptoms in a short term.


Condition Intervention
Bulimia Nervosa
Procedure: Repetitive transcranial Magnetic Stimulation (rTMS)
Procedure: Repetitive transcranial Magnetic Stimulation SHAM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficiency of rTMS in Bulimia: a Controlled Randomized Study

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Efficiency of rTMS in bulimia [ Time Frame: At J0 and J45 (maximum of 45 days between the inclusion visit and the final visit) ] [ Designated as safety issue: No ]
    The objective of this project is to assess whether a program of repetitive transcranial magnetic stimulation (rTMS) under high frequency at the left DLPFC reduces bulimic symptoms in the short term. To do this we will count the number of binge during the 15 days following the last session of rTMS.


Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rTMS
Transcranial magnetic stimulation
Procedure: Repetitive transcranial Magnetic Stimulation (rTMS)
10 TMS sessions of 20 trains of 5s with 55s interval cross train, at a frequency of 10 Hz and 110% of motor threshold intensity of the left DLPFC.
Other Names:
  • Magstim rapid2
  • Reference 3576-23-05
Placebo Comparator: rTMS SHAM
Transcranial magnetic stimulation SHAM
Procedure: Repetitive transcranial Magnetic Stimulation SHAM
Sham treatment will be performed with a placebo coil. The same coil as coil used for rTMS, but it does not deliver magnetic field.
Other Name: Magstim Company

Detailed Description:

Repetitive Transcranial Magnetic Stimulation (rTMS) is a noninvasive outpatient technique of brain stimulation, based on the delivery of the localized magnetic field. It is now widely used a in a variety of neurological and psychiatric disorders.

Several clinical and pathophysiological studies suggest efficacy of rTMS on the reduction of craving and/or addictive behavior in various addictions such as alcoholism, smocking or cocaine. Because of the addictive design of the BN, the effect of one session of rTMS on food craving has been tested.

These studies show that stimulation of left dorsolateral prefrontal cortex (DPLPFC) under high frequency decreases craving food. In addition, in a healthy subject, studies show that rTMS appear to alter neuropsychological functions very involved in physiopathology of bulimia. To date, the investigators do not know if rTMS cold be a useful treatment in the treatment of bulimia. But in the light of these data, the investigators hypothesize that a program of rtMS may have a therapeutic effect and therefore an interest for the treatment of bulimia.

The objective of this project is to assess whether a program of repetitive transcranial magnetic stimulation (rTMS) under high frequency at the left DLPFC reduces bulimic symptoms in the short term.

This is a french multicenter study (Montpellier, Marseille, Saint Etienne), randomized, single blind, two arm, in addition of a treatment already validated (prescription of selective inhibitors of serotonin reuptake inhibitors (SSRIs)). The two arms are : one arm with SSRI + rTMS and an arm with SSRI + sham rTMS (placebo), 30 patients per group will be recruited.

The methodology includes:

  1. an initial clinical and neuropsychological assessment.
  2. 10 TMS sessions of 20 trains of 5s with 55s interval cross train, at a frequency of 10 Hz and 110% of motor threshold intensity of the left DLPFC. Fifty percent of patients will have a real stimulation and and the other fifty percent a sham stimulation. Subjects will be randomized to one or other of the two groups. During the first and last session a food challenge task will be administered before and after rTMS. Salivary cortisol level will be assessed throughout the protocol.
  3. the final clinical and neuropsychological assessment at 1 month (15 days minimum after the last Session of rTMS).

The primary endpoint will focus on the number of binge within 15 days after the last session of rTMS.

If the investigators hypothesis is confirmed the investigators will highlight a new therapeutic modality in the treatment of bulimia. The secondary objectives will permit a better understanding of the pathophysiology of the disorder and ways of possible therapeutic actions of rTMS

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnostic of bulimia nervosa (DSM IV)
  • Women (18-40 years old)
  • right-handed
  • treated by fluoxetine (60mg/j) or escitalopram (30mg/j) for at least 3 weeks.
  • use effective contraceptive measures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530906

Contacts
Contact: sebastien Guillaume, MD Phd 33467338581 s-guillaume@chu-montpellier.fr

Locations
France
Montpellier University Hospital Recruiting
Montpellier, France, 34295
Contact: Sebastien Guillaume    33467338581    s-guillaume@chu-montpellier.fr   
Principal Investigator: philippe Courtet         
Principal Investigator: emilie Olié         
Principal Investigator: Jérome ATTAL         
Sponsors and Collaborators
University Hospital, Montpellier
Centre Hospitalier Universitaire de Saint Etienne
University Hospital, Marseille
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Sebastien Guillaume Montpellier University Hospital
  More Information

Publications:
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01530906     History of Changes
Other Study ID Numbers: 8709, 2011-A01018-33
Study First Received: February 1, 2012
Last Updated: February 7, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Montpellier:
Eating disorders
Bulimia
rTMS
Treatment

Additional relevant MeSH terms:
Bulimia
Bulimia Nervosa
Eating Disorders
Hyperphagia
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 24, 2014