Effect of rTMS in Combination With a Low-carbohydrate Diet in Patients With Obesity

April 26, 2019 updated by: Dra. Monica Ambriz Tututi, Hospital General Ajusco Medio

Effect of Repetitive Transcranial Magnetic Stimulation in Combination With a Low-carbohydrate Diet in Patients With Obesity: a Randomized Controlled Study

In the present study the investigators want to evaluate if the application of rTMS can reduce the anxiety and craving in patients with obesity helping them to follow a low carb-diet, as well as, to assess the changes in weight, body mass index and quality of life before and after rTMS or sham rTMS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants completed a written, informed consent and rTMS adult safety questionnaire. The inclusion criteria are:

individuals between 25 and 60 years of age with obesity in stage 1, 2 or 3. The exclusion criteria were: subjects with metabolic disorders, neurological condition, epilepsy, or pregnancy. The study conformed to the Declaration of Helsinki and was approved by the Institutional Medical Research Ethics Committee (Hospital Ajusco Medio, Mexico DF). The protocol will be applied as follows: 10 rTMS or sham sessions during two weeks. Following these two week, patients will receive 8 more sessions on weeks 4, 6, 8, 10, 12, 16, 20 and 24. Diet will be indicated during all the protocol. The sham group will receive sham rTMS sessions for two weeks, the additional sessions will be performed in the same manner thar in rTMS group.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Tlalpan
      • Mexico, Tlalpan, Mexico, 14250
        • Hospital General Ajusco Medio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI > 30

Exclusion Criteria:

  • Thyroid problems, anorexia, bulimia, epilepsy, schizophrenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rTMS treated group
A Magstim Rapid2 Stimulator equipped with a double 70mm alpha coil P/N 3191-00 (Magstim, Wales, UK) will be used to stimulate the motor cortex. Transcranial magnetic stimulation will be applied through a coil at 10 Hz, a field intensity of 90% of the motor threshold. Stimuli will be provided in 10 trains of 100 pulses, followed by a 28 s rest period.
Device: rTMS
Patients will be stimulated in the dorso lateral frontal cortex. First, the motor threshold will be determined for each patient. To induce currents to the left primary sensory-motor cortex hand area (M1/S1) the coil will be placed over the scalp oriented at 45 ° from the mid-sagittal plane while subjects will sit comfortably on a chair. The coil will be systematically moved in this area until a contraction of the abductor will be identified. Motor evoked potentials (MEPs). MEPs will be registered with surface electrodes on the left hand abductor pollicis muscle using the same Magstim equipment. Then the parameters will be adjusted for the stimulation as was described before.
Other Names:
  • repetitive transcranial magnetic stimulation
Other: Diet
This intervention will be applied to both groups, rTMS and sham group, as a combined therapy. The diet is low in carbohydrates, like sugary foods, pasta and bread. Instead, patients eat food with protein, natural fats and vegetables.
Other Names:
  • conventional treatment
Sham Comparator: sham rTMS group
Sham rTMS will be administered with the coil held in contact with the head but a 180 degrees from scalp, and the power parameter will be reduced by half to avoid stimulation.b
Other: Diet
This intervention will be applied to both groups, rTMS and sham group, as a combined therapy. The diet is low in carbohydrates, like sugary foods, pasta and bread. Instead, patients eat food with protein, natural fats and vegetables.
Other Names:
  • conventional treatment
Device: sham rTMS
As well as the rTMS group, the motor threshold of each patient will be determined. They will experience a similar rTMS session with the difference that they not will be stimulated.
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Obesity, changes in the body mass index
Time Frame: 7 days
Obesity is a body mass index greater than or equal to 30.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Ajusco Medio

Investigators

  • Study Director: Monica Ambriz-Tututi, Dr., HospitalGeneral Ajusco Medio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2017

Primary Completion (Actual)

February 21, 2019

Study Completion (Actual)

February 21, 2019

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

April 30, 2019

Last Update Submitted That Met QC Criteria

April 26, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 211-010-01-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Six months after study conclusion

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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