Transcranial Magnetic Stimulation (TMS) in Binge Eating Disorder (BED)

NCT ID: NCT03540641

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-06

Study Completion Date

2018-12-30

Brief Summary

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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

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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

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Binge-Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1500 pulses

This group will receive 1500 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions

Group Type ACTIVE_COMPARATOR

MagVenture MagPro R30

Intervention Type DEVICE

the subjects will receive 1500 or 5000 pulses at 5Hz

1500 pulses sham

this group will receive the sham modality of the protocol of 1500 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions.

Group Type SHAM_COMPARATOR

MagVenture MagPro R30

Intervention Type DEVICE

the subjects will receive 1500 or 5000 pulses at 5Hz

5000 pulses

This group will receive 5000 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions.

Group Type ACTIVE_COMPARATOR

MagVenture MagPro R30

Intervention Type DEVICE

the subjects will receive 1500 or 5000 pulses at 5Hz

5000 pulses sham

this group will receive the sham modality of the protocol of 5000 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions.

Group Type SHAM_COMPARATOR

MagVenture MagPro R30

Intervention Type DEVICE

the subjects will receive 1500 or 5000 pulses at 5Hz

Interventions

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MagVenture MagPro R30

the subjects will receive 1500 or 5000 pulses at 5Hz

Intervention Type DEVICE

Other Intervention Names

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repetitive Transcranial Magnetic Stimulation

Eligibility Criteria

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Inclusion Criteria

1. Subjects of both sexes.
2. Subjects from 18 to 45 years of age.
3. Subjects with diagnosis of binge eating disorder.
4. Subjects without changes in pharmacological treatment in the last 30 days.
5. Subjects who agree to sign the informed consent letter.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad Autonoma de Queretaro

OTHER

Sponsor Role lead

Responsible Party

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Dr. Julian Reyes López

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julian Reyes López, Doctor

Role: STUDY_DIRECTOR

Universidad Autónoma de Querétaro

Locations

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Sofía Cañizares Gómez.

Querétaro City, Querétaro, Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type RESULT
PMID: 25885566 (View on PubMed)

Orozco-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.

Reference Type RESULT
PMID: 19838321 (View on PubMed)

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.

Reference Type RESULT
PMID: 26265452 (View on PubMed)

Van 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.

Reference Type RESULT
PMID: 20060105 (View on PubMed)

Uher 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.

Reference Type RESULT
PMID: 22654933 (View on PubMed)

Barth 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.

Reference Type RESULT
PMID: 21556279 (View on PubMed)

Lefaucheur 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.

Reference Type RESULT
PMID: 25034472 (View on PubMed)

Other Identifiers

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9320

Identifier Type: -

Identifier Source: org_study_id

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