Bulimia NervosarTMS&bulimiaNCT01530906
Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) in Bulimia
A study testing Repetitive transcranial Magnetic Stimulation (rTMS) in people with Bulimia Nervosa, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bulimia Nervosa
- What is being tested?
- Repetitive transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Montpellier University Hospital
Montpellier, 34295
Sebastien Guillaume, 33467338581, s-guillaume@chu-montpellier.fr
philippe Courtet
About this study
Official title: 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.
Read the 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:
- an initial clinical and neuropsychological assessment.
- 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.
- 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
- Conditions
- Bulimia Nervosa
- Being tested
- Repetitive transcranial Magnetic Stimulation (rTMS), Repetitive transcranial Magnetic Stimulation SHAM
- Keywords
- Eating disorders, Bulimia, rTMS, Treatment
- Medical subject headings
- Bulimia Nervosa, Feeding and Eating Disorders, Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial Magnetic Stimulation (rTMS)Procedure or surgery
Also called Magstim rapid2, Reference 3576-23-05
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.
Repetitive transcranial Magnetic Stimulation SHAMProcedure or surgery
Also called Magstim Company
Sham treatment will be performed with a placebo coil. The same coil as coil used for rTMS, but it does not deliver magnetic field.
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Experimental | 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) Receives: Procedure: Repetitive transcranial Magnetic Stimulation (rTMS) |
| rTMS SHAM | Placebo comparator | 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 Receives: Procedure: Repetitive transcranial Magnetic Stimulation SHAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At J0 and J45 (maximum of 45 days between the inclusion visit and the final visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Saint Etienne, University Hospital, Marseille, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Sebastien Guillaume, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530906
- Sponsor's protocol ID
- 8709
- Other IDs
- 2011-A01018-33
- Acronym
- rTMS&bulimia
- Status last verified
- Feb 2012
- First submitted
- 1 Feb 2012
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21880470Van 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.
PubMed 21067901Guillaume 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.
PubMed 30240526
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of rTMS in Bulimia: a Controlled Randomized Study
- ClinicalTrials.gov ID
- NCT01530906
- Acronym / sponsor ID
- rTMS&bulimia / 8709
- Conditions
- Bulimia Nervosa
- Keywords
- Eating disorders, Bulimia, rTMS, Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Saint Etienne, University Hospital, Marseille, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 10 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- an initial clinical and neuropsychological assessment.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS | Experimental | Procedure: Repetitive transcranial Magnetic Stimulation (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) |
| rTMS SHAM | Placebo comparator | Procedure: Repetitive transcranial Magnetic Stimulation SHAMTranscranial 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Current anorexia as DSM IV criteria
- Current psychiatric disorder unstabilized
- Taking corticosteroid
- History of seizures or epilepsy
- History of head trauma, cerebral pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial Magnetic Stimulation (rTMS)Also: Magstim rapid2, Reference 3576-23-0510 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. | Procedure or surgery | rTMS |
| Repetitive transcranial Magnetic Stimulation SHAMAlso: Magstim CompanySham treatment will be performed with a placebo coil. The same coil as coil used for rTMS, but it does not deliver magnetic field. | Procedure or surgery | rTMS SHAM |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Results publication: PubMed 21880470Van 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.
- Results publication: PubMed 21067901Van 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.
- Derived from this study: PubMed 30240526Guillaume 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastien Guillaume principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial Magnetic Stimulation (rTMS) in people with Bulimia Nervosa, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sebastien Guillaume, MD Phd (33467338581, s-guillaume@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of rTMS in bulimia (time frame: At J0 and J45 (maximum of 45 days between the inclusion visit and the final visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01530906, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.