Binge-Eating DisorderTMS&BEDNCT03540641
Transcranial Magnetic Stimulation (TMS) in Binge Eating Disorder (BED)
A study testing MagVenture MagPro R30 in people with Binge-Eating Disorder, run by Universidad Autonoma de Queretaro at 1 site in Mexico.
Trial summary
This study evaluates de efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) applied on the left dorsolateral prefrontal cortex in patients with binge eating disorder. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- MagVenture MagPro R30
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 6 Apr 2017to 30 Dec 2018
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects of both sexes.
- Subjects from 18 to 45 years of age.
- Subjects with diagnosis of binge eating disorder.
- Subjects without changes in pharmacological treatment in the last 30 days.
- Subjects who agree to sign the informed consent letter.
Who cannot join
- 1.Subjects with a history of traumatic brain injury with loss of consciousness. 2.Subjects with intracranial metallic objects or metal plates in the skull.
- 3.Subjects who suffer chronic diseases not controlled at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases).
- 4.Patients with psychotic symptoms, bipolar affective disorders and substance dependence.
- 5.Subjects with alterations in electroencephalogram (epileptiform activity). 6.Patients with any type of chronic or neurological medical disease not controlled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Transcranial Magnetic Stimulation Applied on the Left Dorsolateral Prefrontal Cortex on the Clinical and Neuropsychological Variables in Subjects With Binge Eating Disorder
This study evaluates de efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) applied on the left dorsolateral prefrontal cortex in patients with binge eating disorder.
Read the detailed description
Binge Eating Disorder (BED) affects a significant percentage of de national population (1.4%) in a portio 2-1 in woman compared with men, the repetitive Transcranial Magnetic Stimulation (rTMS) is a neuromodulation technique, which allows us to induce brain electrical activity by plating magnetic fields and it has been proven that at 10Hz it has an effect of improvement in the craving of food.
- Conditions
- Binge-Eating Disorder
- Being tested
- MagVenture MagPro R30
- Keywords
- Binge Eating Disorder, Transcranial Magnetic Stimulation, Food Craving
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagVenture MagPro R30Device
Also called repetitive Transcranial Magnetic Stimulation
the subjects will receive 1500 or 5000 pulses at 5Hz
| Study group | Role | What they receive |
|---|---|---|
| 1500 pulses | Active comparator | This group will receive 1500 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions Receives: Device: MagVenture MagPro R30 |
| 1500 pulses sham | Sham comparator | this group will receive the sham modality of the protocol of 1500 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions. Receives: Device: MagVenture MagPro R30 |
| 5000 pulses | Active comparator | This group will receive 5000 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions. Receives: Device: MagVenture MagPro R30 |
| 5000 pulses sham | Sham comparator | this group will receive the sham modality of the protocol of 5000 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions. Receives: Device: MagVenture MagPro R30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food Craving Inventory (FCI)
The FCI is a self-report inventory designed to measure the food craving, is made up of 37 elements and is a scale-likert instrument.
Measured: 6 weeks
Secondary outcomes (1)
Barratt Impulsivity Scale (BIS-11)
The Barratt Impulsiveness Scale is a questionnaire designed to assess the personality / behavioral construct of impulsiveness is composed of 30 items describing common impulsive or non-impulsive (for reversed scored items) behaviors and preferences .
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start6 Apr 2017
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Binge-Eating DisorderStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Julian Reyes López, Universidad Autonoma de Queretaro
- Investigators
- Julian Reyes López, Doctor, Study director, Universidad Autónoma de Querétaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03540641
- Sponsor's protocol ID
- 9320
- Acronym
- TMS&BED
- Status last verified
- Apr 2019
- First submitted
- 30 Apr 2018
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amianto F, Ottone L, Abbate Daga G, Fassino S. Binge-eating disorder diagnosis and treatment: a recap in front of DSM-5. BMC Psychiatry. 2015 Apr 3;15:70. doi: 10.1186/s12888-015-0445-6.
PubMed 25885566Orozco-Cabal LF, Herin D. Neurobiologia de la impulsividad y los trastornos de la conducta alimentaria. Rev Colomb Psiquiatr. 2008 Jun 1;37(2):207-219. Spanish.
PubMed 19838321Maranhao 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 26265452Van den Eynde F, Claudino AM, Mogg A, Horrell L, Stahl D, Ribeiro W, Uher R, Campbell I, Schmidt U. Repetitive transcranial magnetic stimulation reduces cue-induced food craving in bulimic disorders. Biol Psychiatry. 2010 Apr 15;67(8):793-5. doi: 10.1016/j.biopsych.2009.11.023. Epub 2010 Jan 8.
PubMed 20060105Uher R, Rutter M. Classification of feeding and eating disorders: review of evidence and proposals for ICD-11. World Psychiatry. 2012 Jun;11(2):80-92. doi: 10.1016/j.wpsyc.2012.05.005.
PubMed 22654933Barth KS, Rydin-Gray S, Kose S, Borckardt JJ, O'Neil PM, Shaw D, Madan A, Budak A, George MS. Food cravings and the effects of left prefrontal repetitive transcranial magnetic stimulation using an improved sham condition. Front Psychiatry. 2011 Mar 14;2:9. doi: 10.3389/fpsyt.2011.00009. eCollection 2011.
PubMed 21556279Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.
PubMed 25034472
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Transcranial Magnetic Stimulation Applied on the Left Dorsolateral Prefrontal Cortex on the Clinical and Neuropsychological Variables in Subjects With Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT03540641
- Acronym / sponsor ID
- TMS&BED / 9320
- Conditions
- Binge-Eating Disorder
- Keywords
- Binge Eating Disorder, Transcranial Magnetic Stimulation, Food Craving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Autonoma de QueretaroUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 30 May 2018 (actual)
- 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.
This study evaluates de efficacy of 5Hz repetitive Transcranial Magnetic Stimulation (rTMS) applied on the left dorsolateral prefrontal cortex in patients with binge eating disorder.
Detailed description
Binge Eating Disorder (BED) affects a significant percentage of de national population (1.4%) in a portio 2-1 in woman compared with men, the repetitive Transcranial Magnetic Stimulation (rTMS) is a neuromodulation technique, which allows us to induce brain electrical activity by plating magnetic fields and it has been proven that at 10Hz it has an effect of improvement in the craving of food.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1500 pulses | Active comparator | Device: MagVenture MagPro R30This group will receive 1500 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions |
| 1500 pulses sham | Sham comparator | Device: MagVenture MagPro R30this group will receive the sham modality of the protocol of 1500 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions. |
| 5000 pulses | Active comparator | Device: MagVenture MagPro R30This group will receive 5000 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions. |
| 5000 pulses sham | Sham comparator | Device: MagVenture MagPro R30this group will receive the sham modality of the protocol of 5000 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects of both sexes.
- Subjects from 18 to 45 years of age.
- Subjects with diagnosis of binge eating disorder.
- Subjects without changes in pharmacological treatment in the last 30 days.
- Subjects who agree to sign the informed consent letter.
Key exclusion criteria (4 listed)
- 1.Subjects with a history of traumatic brain injury with loss of consciousness. 2.Subjects with intracranial metallic objects or metal plates in the skull.
- 3.Subjects who suffer chronic diseases not controlled at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases).
- 4.Patients with psychotic symptoms, bipolar affective disorders and substance dependence.
- 5.Subjects with alterations in electroencephalogram (epileptiform activity). 6.Patients with any type of chronic or neurological medical disease not controlled.
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 |
|---|---|---|
| MagVenture MagPro R30Also: repetitive Transcranial Magnetic Stimulationthe subjects will receive 1500 or 5000 pulses at 5Hz | Device | 1500 pulses, 1500 pulses sham, 5000 pulses, 5000 pulses sham |
Primary outcome
Food Craving Inventory (FCI)
Time frame: 6 weeks
The FCI is a self-report inventory designed to measure the food craving, is made up of 37 elements and is a scale-likert instrument.
1 secondary outcome
Barratt Impulsivity Scale (BIS-11)
Time frame: 6 weeks
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 16 Apr 2019.
- Results publication: PubMed 25885566Amianto F, Ottone L, Abbate Daga G, Fassino S. Binge-eating disorder diagnosis and treatment: a recap in front of DSM-5. BMC Psychiatry. 2015 Apr 3;15:70. doi: 10.1186/s12888-015-0445-6.
- Results publication: PubMed 19838321Orozco-Cabal LF, Herin D. Neurobiologia de la impulsividad y los trastornos de la conducta alimentaria. Rev Colomb Psiquiatr. 2008 Jun 1;37(2):207-219. Spanish.
- Results publication: 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.
- Results publication: PubMed 20060105Van den Eynde F, Claudino AM, Mogg A, Horrell L, Stahl D, Ribeiro W, Uher R, Campbell I, Schmidt U. Repetitive transcranial magnetic stimulation reduces cue-induced food craving in bulimic disorders. Biol Psychiatry. 2010 Apr 15;67(8):793-5. doi: 10.1016/j.biopsych.2009.11.023. Epub 2010 Jan 8.
- Results publication: PubMed 22654933Uher R, Rutter M. Classification of feeding and eating disorders: review of evidence and proposals for ICD-11. World Psychiatry. 2012 Jun;11(2):80-92. doi: 10.1016/j.wpsyc.2012.05.005.
- Results publication: PubMed 21556279Barth KS, Rydin-Gray S, Kose S, Borckardt JJ, O'Neil PM, Shaw D, Madan A, Budak A, George MS. Food cravings and the effects of left prefrontal repetitive transcranial magnetic stimulation using an improved sham condition. Front Psychiatry. 2011 Mar 14;2:9. doi: 10.3389/fpsyt.2011.00009. eCollection 2011.
- Results publication: PubMed 25034472Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.
- Individual participant dataSharing planned: No
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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.
Julian Reyes López, Doctor study director
Universidad Autónoma de Querétaro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagVenture MagPro R30 in people with Binge-Eating Disorder, run by Universidad Autonoma de Queretaro at 1 site in Mexico.
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 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 16 Apr 2019. 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 Mexico. 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?
Food Craving Inventory (FCI) (time frame: 6 weeks). 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 NCT03540641, which also lists 7 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 16 Apr 2019.