Binge EatingNCT02180984
The Effects of Repetitive Transcranial Magnetic Stimulation in Obese People With BED
A study testing TMS in people with Binge Eating and Obesity, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The presence of binge eating (BE) is a core feature of bulimic syndromes. Binge eating disorder (BED) is a new category in DSM-5 highly associated with higher body mass index (BMI). The neural mechanisms that underlie BE are of great interest in order to improve treatment interventions. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Binge Eating, Obesity
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2015to Dec 2020
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 55 years old
- Right handed
- Females
- BED diagnosis (EDE 16.0 - BED module) according to the DSM-5 criteria
- BMI ≥ 35kg/m2 and body weight ≤ 150kg
- Ability to write, read, and understand all elements of the study
- Safety laboratory blood work (fasting glucose, fasting glucose/insulin ratio, CBC, and TSH) within normal range
- Informed consent signed.
Who cannot join
- Past history of head or eye injury or epilepsy
- Body metallic implants, pacemaker, claustrophobia and any other contraindication to fMRI or rTMS;
- Current use of psychotropic drugs (except for antidepressants on a stable dose for at least one month)
- Current use of any anti-obesity drug (three months washout period for any other medication)
- Pregnancy or breastfeeding
- Diabetes Mellitus diagnosis
Show all 10Show fewer
- Major psychiatric disorder requiring immediate treatment
- Substance dependence (SCID-I/P module for substance abuse and/or dependence applied for those who disclose substance use at checklist, following the DSM-5 criteria)
- Individuals currently receiving any psychological therapy for their eating disorder
- Cushing's and Turner's syndrome.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Paulo (Federal University of Sao Paulo) (UNIFESP)
São Paulo, 04021-001
About this study
Official title: The Effects of Repetitive Transcranial Magnetic Stimulation in Obese Females With Binge Eating Disorder: a Protocol for a Double-blinded, Randomized, Sham-controlled Trial.
The presence of binge eating (BE) is a core feature of bulimic syndromes. Binge eating disorder (BED) is a new category in DSM-5 highly associated with higher body mass index (BMI). The neural mechanisms that underlie BE are of great interest in order to improve treatment interventions. Brain mechanisms underlying drug and food craving are suggested to be similar. These mechanisms demonstrated hyperactivity in the orbitofrontal and anterior cingulate cortex and lack of regulatory influence from lateral prefrontal circuits. Several novel studies began to assess the potential benefits of brain stimulation in reducing craving and associated addictive behaviors with promising results. Previous findings testing a one-off session of repetitive transcranial magnetic stimulation (rTMS) in healthy women identified as strong cravers and individuals with bulimia nervosa or bulimic-type eating disorders reported reduction of food craving and BE, providing evidence to support a broader and deeper investigation of the benefits associated with rTMS. Importantly, the use of brain imaging studies contributes to the understanding of psychiatric disorders and underlying mechanisms being target by the rTMS intervention.
Objectives: The primary aim is to investigate the effects of rTMS over BE frequency. Secondary aims include the evaluation of the effects of rTMS on food craving, body weight, brain activity, cognition, general psychopathology, hormonal regulation and neurobiological markers. Methods: Sixty obese females with BED will be randomized to receive 20 sessions of rTMS (n=30) or placebo (n=30) scattered 3 days/week.
Expected Results: Primarily it is expected that rTMS intervention will decrease BE frequency. Consequently, body weight will be reduced. It is also expected that food craving be decreased, cognitive performance be enhanced, and neurobiological markers be improved.
Read the detailed description
The primary aim is to investigate the effects of rTMS over BE frequency. Secondary aims include the evaluation of the effects of rTMS on food craving, body weight, brain activity, cognition, general psychopathology, hormonal regulation and neurobiological markers. Methods: Sixty obese females with BED will be randomized to receive 20 sessions of rTMS (n=30) or placebo (n=30) scattered 3 days/week.
Expected Results: Primarily it is expected that rTMS intervention will decrease BE frequency. Consequently, body weight will be reduced. It is also expected that food craving be decreased, cognitive performance be enhanced, and neurobiological markers be improved.
- Conditions
- Binge Eating, Obesity
- Being tested
- TMS
- Keywords
- Binge Eating, Obesity, TMS, Neuroimage, Neuromodulation, Biomarkers, Eating Disorders, Cognition, Endocrine, Hormones, BDNF, Inflammatory biomarkers
- Medical subject headings
- Bulimia, Obesity, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Also called Repetitive Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation, rTMS
Transcranial Magnetic Stimulation has developed into a powerful tool that utilizes magnetic fluxes to non-invasively stimulate the human cortex. The technique involves placement of a small coil over the scalp; passing a rapidly alternating current through the coil wire, which produces a magnetic field that passes unimpeded through the scalp and bone, resulting in electrical stimulation of the cortex.
| Study group | Role | What they receive |
|---|---|---|
| BED randomized to rTMS | Active comparator | 30 obese individuals currently diagnosed with BED and meeting criteria for the study will be randomized to active rTMS treatment.
Intervention: Neurosoft device targeting the left DLPFC (neuro-navigational method).
Proposed schedule of treatment:
20 sessions of neuronavigated rTMS, one session per day, 3 days/week over approximately 7 weeks. Focal rTMS will be performed using a Neurosoft device and a 'figure of eight' coil. Brainscience Neuronavigation will be used to guide the placement of the coil to the target PFC region using a template MRI for all participants. The coil will be placed at a 45° angle to the mid-sagittal line to induce a posterior to anterior current in the underlying neural tissue. For the real treatment condition, stimulation will target the left DLPFC at 110% of the resting motor threshold. Each session of 10 Hz stimulation will apply 1000 pulses to the left hemisphere, with a duty cycle of 5s on and 55s off, for a total stimulation time of 20 min. Receives: Device: TMS |
| Sham BED TMS | Sham comparator | 30 obese individuals currently diagnosed with BED will be randomized to receive sham TMS treatment. Blinded to participants and study staff, except to the doctor applying the TMS treatment.
Intervention: Neurosoft device targeting the left DLPFC (neuro-navigational method).
Proposed schedule of treatment:
20 sessions of neuronavigated rTMS, one session per day, 3 days/week over approximately 7 weeks. Focal rTMS will be performed using a Neurosoft device and a 'figure of eight' coil. Brainscience Neuronavigation will be used to guide the placement of the coil to the target PFC region using a template MRI for all participants. The coil will be placed at a 45° angle to the mid-sagittal line to induce a posterior to anterior current in the underlying neural tissue. Sham treatment condition, will follow the same protocol however no real TMS will be delivered. Receives: Device: TMS |
| Control (obese non BED) | No intervention | 15 controls, obese but without a current or past diagnosis of BED will complete the baseline measurements only. |
| Controls (normal weight) | No intervention | 15 controls, normal weight and without a current or past diagnosis of BED will complete baseline measures only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of binge eating episodes and craving.
Weekly binge eating episodes frequency will be assessed by the medical doctor. The primary outcomes of this study are: (1) the change in the number of BE episodes before and after study treatment (number of BE episodes at baseline subtracted from the number of BE episodes at the end of treatment), as measured by participants recording of binge episodes in the food diary during the previous 15 days to the baseline visit (first rTMS session,T.3) to the end of treatment visit (T.23); (2) the change in "urge to eat" (craving) as measured in a 10 cm VAS (from T3 to T22).
Measured: Average of 2 months
Secondary outcomes (4)
Change of food craving questionnaires (state and trait) scores
Food craving questionnaires scores will be analyzes at baseline and at the end of the treatment (approximately 2 months). Final scores for each of the participants will be subtracted from the baseline scores.
Measured: Average of 2 months (baseline and end of treatment)
Change in Body Weight
Reduction of baseline body weight (kg) at the end of the treatment (average of 2 months). The final weight will be subtracted from the baseline weight for each of the patients.
Measured: Average of 2 months
Binge eating episodes maintenance
Weekly binge eating episodes frequency will be recorded by participants. Participants will asked to record date, time and description of binge eating episodes. The total number of episodes and frequency distribution for each of the groups will be analyzed.
Measured: 8 weeks follow up (after end of treatment)
Change of visual analogue scale scores
visual analogue scale scores will be analyzes at baseline and at the end of the treatment (approximately 2 months). Final scores for each of the participants will be subtracted from the baseline scores.
Measured: Average of 2 months (baseline and end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startNov 2015
- Primary completionMar 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge EatingStudies 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
- Model description
- Repetitive transcranial magnetic stimulation applied to people with binge eating disorder (real x sham stimulation) only (not for control groups without binge eating disorder)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANGELICA CLAUDINO, Federal University of São Paulo
- Investigators
- Angélica M Claudino, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180984
- Sponsor's protocol ID
- 26164614.7.0000.5505
- Other IDs
- 26164614.7.0000.5505
- Status last verified
- Feb 2021
- First submitted
- 25 Jun 2014
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maranhao MF, Estella NM, Cury ME, Amigo VL, Picasso CM, Berberian A, Campbell I, Schmidt U, Claudino AM. The effects of repetitive transcranial magnetic stimulation in obese females with binge eating disorder: a protocol for a double-blinded, randomized, sham-controlled trial. BMC Psychiatry. 2015 Aug 12;15:194. doi: 10.1186/s12888-015-0569-8.
PubMed 26265452
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Repetitive Transcranial Magnetic Stimulation in Obese Females With Binge Eating Disorder: a Protocol for a Double-blinded, Randomized, Sham-controlled Trial.
- ClinicalTrials.gov ID
- NCT02180984
- Acronym / sponsor ID
- 26164614.7.0000.5505
- Conditions
- Binge Eating, Obesity
- Keywords
- Binge Eating, Obesity, TMS, Neuroimage, Neuromodulation, Biomarkers, Eating Disorders, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 3 Jul 2014 (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.
The presence of binge eating (BE) is a core feature of bulimic syndromes. Binge eating disorder (BED) is a new category in DSM-5 highly associated with higher body mass index (BMI). The neural mechanisms that underlie BE are of great interest in order to improve treatment interventions. Brain mechanisms underlying drug and food craving are suggested to be similar. These mechanisms demonstrated hyperactivity in the orbitofrontal and anterior cingulate cortex and lack of regulatory influence from lateral prefrontal circuits. Several novel studies began to assess the potential benefits of brain stimulation in reducing craving and associated addictive behaviors with promising results. Previous findings testing a one-off session of repetitive transcranial magnetic stimulation (rTMS) in healthy women identified as strong cravers and individuals with bulimia nervosa or bulimic-type eating disorders reported reduction of food craving and BE, providing evidence to support a broader and deeper investigation of the benefits associated with rTMS. Importantly, the use of brain imaging studies contributes to the understanding of psychiatric disorders and underlying mechanisms being target by the rTMS intervention.
Objectives: The primary aim is to investigate the effects of rTMS over BE frequency. Secondary aims include the evaluation of the effects of rTMS on food craving, body weight, brain activity, cognition, general psychopathology, hormonal regulation and neurobiological markers. Methods: Sixty obese females with BED will be randomized to receive 20 sessions of rTMS (n=30) or placebo (n=30) scattered 3 days/week.
Expected Results: Primarily it is expected that rTMS intervention will decrease BE frequency. Consequently, body weight will be reduced. It is also expected that food craving be decreased, cognitive performance be enhanced, and neurobiological markers be improved.
Detailed description
The primary aim is to investigate the effects of rTMS over BE frequency. Secondary aims include the evaluation of the effects of rTMS on food craving, body weight, brain activity, cognition, general psychopathology, hormonal regulation and neurobiological markers. Methods: Sixty obese females with BED will be randomized to receive 20 sessions of rTMS (n=30) or placebo (n=30) scattered 3 days/week.
Expected Results: Primarily it is expected that rTMS intervention will decrease BE frequency. Consequently, body weight will be reduced. It is also expected that food craving be decreased, cognitive performance be enhanced, and neurobiological markers be improved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Repetitive transcranial magnetic stimulation applied to people with binge eating disorder (real x sham stimulation) only (not for control groups without binge eating disorder)
| Arm | Type | Receives |
|---|---|---|
| BED randomized to rTMS | Active comparator | Device: TMS30 obese individuals currently diagnosed with BED and meeting criteria for the study will be randomized to active rTMS treatment. Intervention: Neurosoft device targeting the left DLPFC (neuro-navigational method). Proposed schedule of treatment: 20 sessions of neuronavigated rTMS, one session per day, 3 days/week over approximately 7 weeks. Focal rTMS will be performed using a Neurosoft device and a 'figure of eight' coil. Brainscience Neuronavigation will be used to guide the placement of the coil to the target PFC region using a template MRI for all participants. The coil will be placed at a 45° angle to the mid-sagittal line to induce a posterior to anterior current in the underlying neural tissue. For the real treatment condition, stimulation will target the left DLPFC at 110% of the resting motor threshold. Each session of 10 Hz stimulation will apply 1000 pulses to the left hemisphere, with a duty cycle of 5s on and 55s off, for a total stimulation time of 20 min. |
| Sham BED TMS | Sham comparator | Device: TMS30 obese individuals currently diagnosed with BED will be randomized to receive sham TMS treatment. Blinded to participants and study staff, except to the doctor applying the TMS treatment. Intervention: Neurosoft device targeting the left DLPFC (neuro-navigational method). Proposed schedule of treatment: 20 sessions of neuronavigated rTMS, one session per day, 3 days/week over approximately 7 weeks. Focal rTMS will be performed using a Neurosoft device and a 'figure of eight' coil. Brainscience Neuronavigation will be used to guide the placement of the coil to the target PFC region using a template MRI for all participants. The coil will be placed at a 45° angle to the mid-sagittal line to induce a posterior to anterior current in the underlying neural tissue. Sham treatment condition, will follow the same protocol however no real TMS will be delivered. |
| Control (obese non BED) | No intervention | –15 controls, obese but without a current or past diagnosis of BED will complete the baseline measurements only. |
| Controls (normal weight) | No intervention | –15 controls, normal weight and without a current or past diagnosis of BED will complete baseline measures only. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 18 to 55 years old
- Right handed
- Females
- BED diagnosis (EDE 16.0 - BED module) according to the DSM-5 criteria
- BMI ≥ 35kg/m2 and body weight ≤ 150kg
Key exclusion criteria (10 listed)
- Past history of head or eye injury or epilepsy
- Body metallic implants, pacemaker, claustrophobia and any other contraindication to fMRI or rTMS;
- Current use of psychotropic drugs (except for antidepressants on a stable dose for at least one month)
- Current use of any anti-obesity drug (three months washout period for any other medication)
- Pregnancy or breastfeeding
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 |
|---|---|---|
| TMSAlso: Repetitive Transcranial Magnetic Stimulation, Transcranial Magnetic Stimulation, rTMSTranscranial Magnetic Stimulation has developed into a powerful tool that utilizes magnetic fluxes to non-invasively stimulate the human cortex. The technique involves placement of a small coil over the scalp; passing a rapidly alternating current through the coil wire, which produces a magnetic field that passes unimpeded through the scalp and bone, resulting in electrical stimulation of the cortex. | Device | BED randomized to rTMS, Sham BED TMS |
Primary outcome
Change in the number of binge eating episodes and craving.
Time frame: Average of 2 months
Weekly binge eating episodes frequency will be assessed by the medical doctor. The primary outcomes of this study are: (1) the change in the number of BE episodes before and after study treatment (number of BE episodes at baseline subtracted from the number of BE episodes at the end of treatment), as measured by participants recording of binge episodes in the food diary during the previous 15 days to the baseline visit (first rTMS session,T.3) to the end of treatment visit (T.23); (2) the change in "urge to eat" (craving) as measured in a 10 cm VAS (from T3 to T22).
4 secondary outcomes
Change of food craving questionnaires (state and trait) scores
Time frame: Average of 2 months (baseline and end of treatment)
Change in Body Weight
Time frame: Average of 2 months
Binge eating episodes maintenance
Time frame: 8 weeks follow up (after end of treatment)
Change of visual analogue scale scores
Time frame: Average of 2 months (baseline and end of treatment)
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 5 Feb 2021.
- Background: PubMed 26265452Maranhao MF, Estella NM, Cury ME, Amigo VL, Picasso CM, Berberian A, Campbell I, Schmidt U, Claudino AM. The effects of repetitive transcranial magnetic stimulation in obese females with binge eating disorder: a protocol for a double-blinded, randomized, sham-controlled trial. BMC Psychiatry. 2015 Aug 12;15:194. doi: 10.1186/s12888-015-0569-8.
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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.
Angélica M Claudino, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Binge Eating and Obesity, run by Federal University of São Paulo at 1 site in Brazil.
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 8 inclusion and 10 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 5 Feb 2021. 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 Brazil. 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?
Change in the number of binge eating episodes and craving. (time frame: Average of 2 months). 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 NCT02180984, which also lists 1 linked publication.
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 5 Feb 2021.