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

December 2, 2014 updated by: University Hospital, Montpellier

Efficiency of rTMS in Bulimia: a Controlled Randomized Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Montpellier, France, 34295
        • Recruiting
        • Montpellier University Hospital
        • Contact:
        • Principal Investigator:
          • philippe Courtet
        • Principal Investigator:
          • emilie Olié
        • Principal Investigator:
          • Jérome ATTAL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Exclusion criteria:

  • Current anorexia as DSM IV criteria
  • Current psychiatric disorder unstabilized
  • Taking corticosteroid
  • History of seizures or epilepsy
  • History of head trauma, cerebral pathology
  • Serious physical illness unstabilized
  • Prior use of the TMS
  • pregnancy or breastfeeding
  • Somatic disease may affect cognitive abilities and brain structures
  • Loss of personal capacity resulting in state protection
  • Deprivation of liberty by judicial or administrative decision
  • Patients with pacemakers, defibrillator, neuro stimulator implanted.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS

patients included in this arm will receive 10 sessions of transcranial magnetic stimulation (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 be included in this arm. 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 Intervention: Repetitive transcranial Magnetic Stimulation (rTMS)
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 Intervention: Repetitive transcranial Magnetic Stimulation SHAM Fifty percent of patients will be included in this arm. 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
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 Names:
  • Magstim Company

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficiency of rTMS in bulimia
Time Frame: At J0 and J45 (maximum of 45 days between the inclusion visit and the final visit)
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.
At J0 and J45 (maximum of 45 days between the inclusion visit and the final visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Centre Hospitalier Universitaire de Saint Etienne
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Marseille

Investigators

  • Principal Investigator: Sebastien Guillaume, Montpellier University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

February 1, 2012

First Submitted That Met QC Criteria

February 7, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8709 (Other Identifier: CTEP)
  • 2011-A01018-33 (Other Identifier: ID-RCB (Afssaps))

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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