ClinicalTrials.gg
CompletedNCT03345368Updated Apr 30, 2019

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

An interventional study of rTMS and sham rTMS in Obesity and Anxiety, sponsored by Hospital General Ajusco Medio. Completed at 1 site in Mexico. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-04-30.

Sponsored by Hospital General Ajusco Medio · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 212 studies in Obesity with a site in Mexico — 42 open to participants now, 61 under way, 29 of them phase 3. Obesity · Mexico.

Enrollment
134th of 190
49 · median 104
Started
2017
with 6 others
No phase
99 of 212
15 open now
Registered
63rd of 212
by date

Among the 212 studies in Obesity with a site in Mexico, this one is the 134th largest by enrollment of the 190 interventional ones that give a count, is one of 7 that started in 2017, is one of 99 with no phase, and was the 63rd registered.

Obesity

11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.

Browse Obesity studies →

Open to participants now

42 of the 212 studies in Obesity with a site in Mexico are open now. Recruiting first, the newest first:

37 more — sign in →

All 42 open studies →

A study can be open while its sites in Mexico have not opened yet or have stopped. Only those recruiting at a site in Mexico →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.

This study: 18 Years to 40 Years · all sexes · no healthy volunteers.

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02

Study summary

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.

Read the 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.

03

Conditions studied

  • Obesity
  • Anxiety

Keywords

  • transcranial magnetic stimulation
  • obesity
  • diet
04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • > 30

Exclusion criteria

Exclusion Criteria:

  • Thyroid problems, anorexia, bulimia, epilepsy, schizophrenia
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
49 participants (actual)

Study arms

  • 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 · Other: Diet

  • 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

    Device: sham rTMS · Other: Diet

Interventions

  • DevicerTMS

    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.

    Also known as: repetitive transcranial magnetic stimulation

  • Devicesham 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.

    Also known as: placebo

  • OtherDiet

    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.

    Also known as: conventional treatment

06

What researchers measure

Primary outcomes

  1. Obesity, changes in the body mass index

    Obesity is a body mass index greater than or equal to 30.

    Time frame: 7 days

07

Study locations

1 site
  • Hospital General Ajusco Medio
    Mexico, Tlalpan 14250, Mexico
08

References and documents

Publications

  • Alonso-Alonso M, Pascual-Leone A. The right brain hypothesis for obesity. JAMA. 2007 Apr 25;297(16):1819-22. doi: 10.1001/jama.297.16.1819. No abstract available. PubMed 17456824 ↗
  • Kober H, Mende-Siedlecki P, Kross EF, Weber J, Mischel W, Hart CL, Ochsner KN. Prefrontal-striatal pathway underlies cognitive regulation of craving. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14811-6. doi: 10.1073/pnas.1007779107. Epub 2010 Aug 2. PubMed 20679212 ↗
  • 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. PubMed 21556279 ↗
  • Uher R, Yoganathan D, Mogg A, Eranti SV, Treasure J, Campbell IC, McLoughlin DM, Schmidt U. Effect of left prefrontal repetitive transcranial magnetic stimulation on food craving. Biol Psychiatry. 2005 Nov 15;58(10):840-2. doi: 10.1016/j.biopsych.2005.05.043. Epub 2005 Aug 8. PubMed 16084855 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Six months after study conclusion

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Feb 2019, 16 months.

Of 3,683 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 16 months is below that.

Counting every sponsor, half of 3,846 studies reached it within 22 months; a quarter within 9 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2017
First posted
Nov 17, 2017
StartActual
Sep 26, 2017
Primary completionActual
Feb 21, 2019
CompletionActual
Feb 21, 2019
Last update
Apr 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03345368
Lead sponsor
Hospital General Ajusco Medio
Responsible party
Dra. Monica Ambriz Tututi (Especialista en área de Salud, Hospital General Ajusco Medio) — Principal investigator
First posted
Nov 17, 2017
Start date
Sep 26, 2017
Primary completion
Feb 21, 2019
Completion
Feb 21, 2019
Last update
Apr 30, 2019

Study contacts

Monica Ambriz-Tututi, Dr.
study director · HospitalGeneral Ajusco Medio

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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