Anorexia NervosaSTIMOREXNCT01717079
rTMS and Body Shape Perception
A study testing rTMS in people with Anorexia Nervosa, run by University Hospital, Rouen at 1 site in France.
Trial summary
Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder characterized by a resistance to maintaining body weight at or above a minimally normal weight for age and height, an intense fear of weight gain or being "fat" even though underweight, a loss of menstrual periods in girls and women… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- rTMS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- May 2013to 15 Dec 2017
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age above 18
- Restrictive anorexia nervosa with a disease duration more than one year and less than three years.
- Body Mass Index below 16
- Patient receiving or having received optimal treatment for anorexia nervosa
- Right-handed
Show all 9Show fewer
- Normal blood ionogramme
- Previous stable antidepressor treatment for one month and no expected modification in the three following months
- Patients arriving by car with someone else or by public transportation
Who cannot join
- Pregnancy
- Contraindication to transcranial magnetic stimulation i.e. pace-maker, cardiac valve protheses, metallic protheses etc.
- History of epileptic seizure
- Cerebral lesion of any etiology (post-traumatic, tumoral, vascular etc.)
- History of previous rTMS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Transcranial Magnetic Stimulation on Disturbance of Body Shape Perception in Patients With Anorexia Nervosa
Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder characterized by a resistance to maintaining body weight at or above a minimally normal weight for age and height, an intense fear of weight gain or being "fat" even though underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in the experience of body weight or shape. Body weight and shape dissatisfaction is linked to the development, maintenance and relapse of AN. Neuroimaging studies have shown that the inferior parietal cortex is involved in body image perception and less activated in patients with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS) is used to modulate cortical excitability, and particularly to increase excitability with high-frequency rTMS. The aim of this study was to investigate the effect of "excitatory" high-frequency rTMS over the "hypoactive" inferior parietal cortex of 54 patients with AN.
This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000 ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10 sessions in two weeks) versus placebo rTMS.
Read more
Assessments will be performed before rTMS and after the last rTMS session (immediately after, at 15 days and three months). The principal criteria for judgement is a body image satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker for eating disorders recently described).
Inferior parietal cortex rTMS could not only improve body image perception, but also help in the treatment of eating disorders, allowing weight gain with a decreased anxiety and improving patients' quality of life. Also positive results could have direct therapeutic implications with the possibility to complete regular rTMS sessions, or to implant extradural electrodes for chronic parietal cortex stimulation.
- Conditions
- Anorexia Nervosa
- Being tested
- Sham rTMS, rTMS
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham rTMSProcedure or surgery
120 pulses 0.2Hz
rTMSProcedure or surgery
120 pulses 0.2Hz
| Study group | Role | What they receive |
|---|---|---|
| Effective arm | Active comparator | Effective coil Receives: Procedure: rTMS |
| Placebo arm | Placebo comparator | Placebo coil Receives: Procedure: Sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSQ-34 scale (Body Shape Questionnaire)
Measured: Just after rTMS
Secondary outcomes (11)
EAT-40 scale (eating attitude test)
Measured: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
BULIT scale (bulimia test)
Measured: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
EDI-2 scale (eating disorder inventory)
Measured: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Hamilton scale
Measured: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMSBefore rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Quality of Life Scale, MOS 36 Item Short-Form Health Survey or SF-36
Measured: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
The body mass index
Measured: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
body composition analysis using dual energy X-ray absorptiometry
Measured: Before rTMS and 3 months after rTMS
autoantibodies against alpha-melanocyte stimulating hormone
Measured: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
The adverse effects
Measured: After rTMS
Weight
Measured: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
BSQ-34 scale (Body Shape Questionnaire)
Measured: Before rTMS, 15 days after rTMS and 3 months after rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startMay 2013
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Why it stopped: Protocol stopped for safety reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie CHASTAN, MD, Principal investigator, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717079
- Sponsor's protocol ID
- 2011/122/HP
- Acronym
- STIMOREX
- Status last verified
- May 2018
- First submitted
- 24 Sep 2012
- Last updated
- 30 May 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Magnetic Stimulation on Disturbance of Body Shape Perception in Patients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT01717079
- Acronym / sponsor ID
- STIMOREX / 2011/122/HP
- Conditions
- Anorexia Nervosa
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol stopped for safety reason
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 30 Oct 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.
Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder characterized by a resistance to maintaining body weight at or above a minimally normal weight for age and height, an intense fear of weight gain or being "fat" even though underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in the experience of body weight or shape. Body weight and shape dissatisfaction is linked to the development, maintenance and relapse of AN. Neuroimaging studies have shown that the inferior parietal cortex is involved in body image perception and less activated in patients with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS) is used to modulate cortical excitability, and particularly to increase excitability with high-frequency rTMS. The aim of this study was to investigate the effect of "excitatory" high-frequency rTMS over the "hypoactive" inferior parietal cortex of 54 patients with AN.
This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000 ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10 sessions in two weeks) versus placebo rTMS.
Assessments will be performed before rTMS and after the last rTMS session (immediately after, at 15 days and three months). The principal criteria for judgement is a body image satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker for eating disorders recently described).
Inferior parietal cortex rTMS could not only improve body image perception, but also help in the treatment of eating disorders, allowing weight gain with a decreased anxiety and improving patients' quality of life. Also positive results could have direct therapeutic implications with the possibility to complete regular rTMS sessions, or to implant extradural electrodes for chronic parietal cortex stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effective arm | Active comparator | Procedure: rTMSEffective coil |
| Placebo arm | Placebo comparator | Procedure: Sham rTMSPlacebo coil |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female
- Age above 18
- Restrictive anorexia nervosa with a disease duration more than one year and less than three years.
- Body Mass Index below 16
- Patient receiving or having received optimal treatment for anorexia nervosa
Key exclusion criteria (5 listed)
- Pregnancy
- Contraindication to transcranial magnetic stimulation i.e. pace-maker, cardiac valve protheses, metallic protheses etc.
- History of epileptic seizure
- Cerebral lesion of any etiology (post-traumatic, tumoral, vascular etc.)
- History of previous rTMS
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 |
|---|---|---|
| Sham rTMS120 pulses 0.2Hz | Procedure or surgery | Placebo arm |
| rTMS120 pulses 0.2Hz | Procedure or surgery | Effective arm |
Primary outcome
BSQ-34 scale (Body Shape Questionnaire)
Time frame: Just after rTMS
11 secondary outcomes
EAT-40 scale (eating attitude test)
Time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
BULIT scale (bulimia test)
Time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
EDI-2 scale (eating disorder inventory)
Time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Hamilton scale
Time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMSBefore rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
Quality of Life Scale, MOS 36 Item Short-Form Health Survey or SF-36
Time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
The body mass index
Time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
body composition analysis using dual energy X-ray absorptiometry
Time frame: Before rTMS and 3 months after rTMS
autoantibodies against alpha-melanocyte stimulating hormone
Time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
The adverse effects
Time frame: After rTMS
Weight
Time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
BSQ-34 scale (Body Shape Questionnaire)
Time frame: Before rTMS, 15 days after rTMS and 3 months after rTMS
Results and safety
The study was stopped early (reason given: Protocol stopped for safety reason). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
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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.
Nathalie CHASTAN, MD principal investigator
UH Rouen
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 in people with Anorexia Nervosa, run by University Hospital, Rouen 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 9 inclusion and 5 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: stopped early, as of the sponsor's last update on 30 May 2018. 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 was stopped early (reason given: Protocol stopped for safety reason). Results are not available in the source record.
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?
BSQ-34 scale (Body Shape Questionnaire) (time frame: Just after rTMS). 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 30 May 2018.