NCT03540641

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 6, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

April 30, 2018

Last Update Submit

April 15, 2019

Conditions

Binge-Eating Disorder

Keywords

Binge Eating DisorderTranscranial Magnetic StimulationFood Craving

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (1)

  • Barratt Impulsivity Scale (BIS-11)

    6 weeks

Study Arms (4)

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

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.

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.

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.

Device: MagVenture MagPro R30

Interventions

MagVenture MagPro R30DEVICE

the subjects will receive 1500 or 5000 pulses at 5Hz

Also known as: repetitive Transcranial Magnetic Stimulation
1500 pulses1500 pulses sham5000 pulses5000 pulses sham

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects with a history of traumatic brain injury with loss of consciousness. 2.Subjects with intracranial metallic objects or metal plates in the skull.
  • Subjects who suffer chronic diseases not controlled at the time of entering the study (for example: hypertension, diabetes, rheumatic diseases).
  • Patients with psychotic symptoms, bipolar affective disorders and substance dependence.
  • Subjects with alterations in electroencephalogram (epileptiform activity). 6.Patients with any type of chronic or neurological medical disease not controlled.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sofía Cañizares Gómez.

Querétaro City, Querétaro, 76170, Mexico

Location

Related Publications (7)

  • 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.

    PMID: 25885566RESULT

  • 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.

    PMID: 19838321RESULT

  • 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.

    PMID: 26265452RESULT

  • 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.

    PMID: 20060105RESULT

  • 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.

    PMID: 22654933RESULT

  • 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.

    PMID: 21556279RESULT

  • 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.

    PMID: 25034472RESULT

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Julian Reyes López, Doctor

    Universidad Autónoma de Querétaro

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 30, 2018

Study Start

April 6, 2017

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)