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

Primary Purpose

Binge-Eating Disorder

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
MagVenture MagPro R30
Sponsored by
Universidad Autonoma de Queretaro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge-Eating Disorder focused on measuring Binge Eating Disorder, Transcranial Magnetic Stimulation, Food Craving

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sofía Cañizares Gómez.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

1500 pulses

1500 pulses sham

5000 pulses

5000 pulses sham

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 .

Full Information

First Posted
April 30, 2018
Last Updated
April 15, 2019
Sponsor
Universidad Autonoma de Queretaro
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1. Study Identification

Unique Protocol Identification Number
NCT03540641
Brief Title
Transcranial Magnetic Stimulation (TMS) in Binge Eating Disorder (BED)
Acronym
TMS&BED
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 6, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Queretaro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder
Keywords
Binge Eating Disorder, Transcranial Magnetic Stimulation, Food Craving

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1500 pulses
Arm Type
Active Comparator
Arm Description
This group will receive 1500 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions
Arm Title
1500 pulses sham
Arm Type
Sham Comparator
Arm Description
this group will receive the sham modality of the protocol of 1500 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions.
Arm Title
5000 pulses
Arm Type
Active Comparator
Arm Description
This group will receive 5000 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions.
Arm Title
5000 pulses sham
Arm Type
Sham Comparator
Arm Description
this group will receive the sham modality of the protocol of 5000 pulses at 5Hz of transcranial magnetic stimulation during 15 sessions.
Intervention Type
Device
Intervention Name(s)
MagVenture MagPro R30
Other Intervention Name(s)
repetitive Transcranial Magnetic Stimulation
Intervention Description
the subjects will receive 1500 or 5000 pulses at 5Hz
Primary Outcome Measure Information:
Title
Food Craving Inventory (FCI)
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Barratt Impulsivity Scale (BIS-11)
Description
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 .
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Reyes López, Doctor
Organizational Affiliation
Universidad Autónoma de Querétaro
Official's Role
Study Director
Facility Information:
Facility Name
Sofía Cañizares Gómez.
City
Querétaro City
State/Province
Querétaro
ZIP/Postal Code
76170
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25885566
Citation
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.
Results Reference
result
PubMed Identifier
19838321
Citation
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.
Results Reference
result
PubMed Identifier
26265452
Citation
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.
Results Reference
result
PubMed Identifier
20060105
Citation
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.
Results Reference
result
PubMed Identifier
22654933
Citation
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.
Results Reference
result
PubMed Identifier
21556279
Citation
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.
Results Reference
result
PubMed Identifier
25034472
Citation
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.
Results Reference
result

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

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