BulimiaNCT02547246
Transcranial Magnetic Stimulation and Bulimic Craving
A study testing rTMS session in people with Bulimia, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Bulimia
- What is being tested?
- rTMS session
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jul 2014
- 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
- right-handed patient
- Patients without psychotropic treatment or treatment with a stable and unchanged for over a month.
- Normal BMI
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Magnetic Stimulation, Embodied Cognition and Bulimic Craving
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.
Read the 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
- Being tested
- rTMS session, rTMS Placebo (SHAM)
- Keywords
- bulimia, repetitive transcranial magnetic stimulation (rTMS)
- Medical subject headings
- Bulimia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS sessionDevice
One session of rTMS at a frequency of 10 Hz during 20 minutes
rTMS Placebo (SHAM)Device
One session of placebo (SHAM) rTMS during 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| rTMS session | Experimental | Patients will have a 20 minute session of rTMS at a frequency of 10 Hz. Receives: Device: rTMS session |
| rTMS placebo (SHAM) session | Placebo comparator | Patients will have a 20 minute session of placebo rTMS Receives: Device: rTMS Placebo (SHAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor response time
time taken to pull or push the lever in cognitive tests (composite measure)
Measured: 24h after rTMS session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startJan 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BulimiaStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torrance SIGAUD, MD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547246
- Sponsor's protocol ID
- 1108053
- Other IDs
- 2011-A00481-40
- Status last verified
- Mar 2016
- First submitted
- 9 Sep 2015
- Last updated
- 23 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation, Embodied Cognition and Bulimic Craving
- ClinicalTrials.gov ID
- NCT02547246
- Acronym / sponsor ID
- 1108053
- Conditions
- Bulimia
- Keywords
- bulimia, repetitive transcranial magnetic stimulation (rTMS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 11 Sep 2015 (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.
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
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS session | Experimental | Device: rTMS sessionPatients will have a 20 minute session of rTMS at a frequency of 10 Hz. |
| rTMS placebo (SHAM) session | Placebo comparator | Device: rTMS Placebo (SHAM)Patients will have a 20 minute session of placebo rTMS |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- right-handed patient
- Patients without psychotropic treatment or treatment with a stable and unchanged for over a month.
- Normal BMI
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| rTMS sessionOne session of rTMS at a frequency of 10 Hz during 20 minutes | Device | rTMS session |
| rTMS Placebo (SHAM)One session of placebo (SHAM) rTMS during 20 minutes | Device | rTMS placebo (SHAM) session |
Primary outcome
Motor response time
Time frame: 24h after rTMS session
time taken to pull or push the lever in cognitive tests (composite measure)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Bulimia
Active, not recruitingEarly Phase 1
Naltrexone Neuroimaging in Teens With Eating Disorders
Eating Disorders, Binge Eating
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
RecruitingPhase 4
A Neuropsychobiological Approach to Optimize Patient Selection for GLP-1-based Pharmacotherapy for Weight Management Across the Binge Eating Spectrum
Obesity & Overweight
Not yet recruiting
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
Binge Eating, Overweight and Obesity
Recruiting
Testing Intervention Strategies for Addressing Binge Eating and Food Insecurity
Binge Eating, Food Insecurity
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.
Torrance SIGAUD, MD principal investigator
CHU de SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS session in people with Bulimia, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 23 Mar 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor response time (time frame: 24h after rTMS session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2016.