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

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ClinicalTrials.gov Identifier: NCT03540641
Recruitment Status : Completed
First Posted : May 30, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Julian Reyes López, Universidad Autonoma de Queretaro

Tracking Information
First Submitted Date  ICMJE April 30, 2018
First Posted Date  ICMJE May 30, 2018
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE April 6, 2017
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03540641 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
Barratt Impulsivity Scale (BIS-11) [ Time Frame: 6 weeks ]
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 .
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Magnetic Stimulation (TMS) in Binge Eating Disorder (BED)
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Binge-Eating Disorder
Intervention  ICMJE Device: MagVenture MagPro R30
the subjects will receive 1500 or 5000 pulses at 5Hz
Other Name: repetitive Transcranial Magnetic Stimulation
Study Arms  ICMJE
  • Active Comparator: 1500 pulses
    This group will receive 1500 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions
    Intervention: Device: MagVenture MagPro R30
  • Sham Comparator: 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.
    Intervention: Device: MagVenture MagPro R30
  • Active Comparator: 5000 pulses
    This group will receive 5000 pulses of transcranial magnetic stimulation at 5Hz over the left dorsolateral prefrontal cortex, until completing 15 sessions.
    Intervention: Device: MagVenture MagPro R30
  • Sham Comparator: 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.
    Intervention: Device: MagVenture MagPro R30
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 30, 2018
Actual Primary Completion Date December 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03540641
Other Study ID Numbers  ICMJE 9320
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Julian Reyes López, Universidad Autonoma de Queretaro
Study Sponsor  ICMJE Universidad Autonoma de Queretaro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Julian Reyes López, Doctor Universidad Autónoma de Querétaro
PRS Account Universidad Autonoma de Queretaro
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP