Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) in Bulimia
rTMS&bulimia
Efficiency of rTMS in Bulimia: a Controlled Randomized Study
2 other identifiers
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 1, 2012
CompletedFirst Posted
Study publicly available on registry
February 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedDecember 3, 2014
February 1, 2012
3.2 years
February 1, 2012
December 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficiency of rTMS in 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. 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)
Study Arms (2)
rTMS
EXPERIMENTALpatients 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)
rTMS SHAM
PLACEBO COMPARATORTranscranial 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
Interventions
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.
Sham treatment will be performed with a placebo coil. The same coil as coil used for rTMS, but it does not deliver magnetic field.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montpellier University Hospital
Montpellier, 34295, France
Related Publications (3)
Van den Eynde F, Guillaume S, Broadbent H, Campbell IC, Schmidt U. Repetitive transcranial magnetic stimulation in anorexia nervosa: a pilot study. Eur Psychiatry. 2013 Feb;28(2):98-101. doi: 10.1016/j.eurpsy.2011.06.002. Epub 2011 Aug 30.
PMID: 21880470RESULTVan den Eynde F, Broadbent H, Guillaume S, Claudino A, Campbell IC, Schmidt U. Handedness, repetitive transcranial magnetic stimulation and bulimic disorders. Eur Psychiatry. 2012 May;27(4):290-3. doi: 10.1016/j.eurpsy.2010.08.015. Epub 2010 Nov 9.
PMID: 21067901RESULTGuillaume S, Gay A, Jaussent I, Sigaud T, Billard S, Attal J, Seneque M, Galusca B, Thiebaut S, Massoubre C, Courtet P. Improving decision-making and cognitive impulse control in bulimia nervosa by rTMS: An ancillary randomized controlled study. Int J Eat Disord. 2018 Sep;51(9):1103-1106. doi: 10.1002/eat.22942. Epub 2018 Sep 21.
PMID: 30240526DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastien Guillaume
Montpellier University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2012
First Posted
February 10, 2012
Study Start
January 1, 2012
Primary Completion
March 1, 2015
Study Completion
September 1, 2015
Last Updated
December 3, 2014
Record last verified: 2012-02