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The Effectiveness of Repetitive Transcranial Magnetic Stimulation for Weight Loss in Overweight and Obese Patients

L

Larissa University Hospital

Status

Active, not recruiting

Conditions

Obesity and Overweight
Food Cravings

Treatments

Device: Transcranial Magnetic Stimulation Sham
Device: TMS

Study type

Interventional

Funder types

Other

Identifiers

NCT06945731
28/01/2022/3672

Details and patient eligibility

About

This doctoral dissertation takes into account epidemiological and clinical data of the international literature about obesity and, generally, increased body weight (BMI≥ 25kg/m2) and their consequences on health. Obesity management challenges many specialties, while, currently, the approved therapeutic methods are dietary intervention, various drugs and, in severe cases, bariatric surgery. All of the above methods show some degree of recurrence, while surgery carries the risk of serious complications.

Repetitive transcranial magnetic stimulation (rTMS) is classified into non-invasive brain stimulation methods and utilizes magnetic pulses generated by a coil to bring about changes in the brain. The method has already been approved for the treatment of some disorders, while it seems to help in the fight against many more psychiatric and neurological, mainly, diseases. The aim of the research will be to investigate the effectiveness of TMS in reducing body weight in participants with BMI≥ 25kg/m2.

The doctoral dissertation will study the reduction of BMI in obese and overweight patients and the variation of this reduction depending on the severity of obesity and age. In addition, it will investigate the effectiveness by setting as a parameter the observance of a diet. It will also record and statistically process the improvement of symptoms in the spectrum of some psychiatric disorders (eg depressive and psychotic symptoms, psychosomatic disorders).

The participants in the research will be hospitalized patients of the Psychiatric Clinic of the University General Hospital of Larissa (PGNL) and citizens. Clearly, patients from other clinics or other citizens can also participate in the research, provided they have a BMI≥ 25kg/m2. They will undergo 20 rTMS sessions (4 per week, for 5 weeks) and an assessment of BMI and some psychiatric symptoms before the start, at the end, 4 weeks after and 6 months after the end of the sessions. The rTMS will be applied to the left dorsal prefrontal cortex (left DLPFC), with an 8-coil in the following conditions: frequency 10 Hz, 75 4-second trains with 26-second intertrain interval, at 120% of the threshold for motor cortex activation. Participants will be divided into three groups: those who will not receive TMS, those who will receive sham TMS and those who will receive active TMS. These patients will then be compared with each other to answer the research questions. The therapeutic protocol presented is based on the international literature, while it presents positive results in the studies in which it has been applied.

Prerequisites for participation in the study are patient consent and BMI≥ 25kg/m2. In order to receive TMS, the patient first needs to agree and clarify that he / she does not have an individual or family history of seizures and that he / she does not have a cochlear implant. If the patient wishes, he can withdraw from the study at any stage. In addition to seizures, other side effects of treatment include headache and hearing loss (for which the patient will use earplugs).

The present dissertation will contribute to the further understanding of the mechanisms of obesity as well as the development of new therapies for the treatment of the disease.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age over 18 years
  • BMI > 25 kg/m²
  • Ability to provide written consent

Exclusion criteria

  • History of epilepsy
  • Active alcohol or substance abuse
  • Severe active health condition
  • Cochlear implants
  • Inability to provide written consent
  • BMI < 25 kg/m²
  • Age under 18 years

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

Active
Active Comparator group
Treatment:
Device: TMS
Sham
Sham Comparator group
Treatment:
Device: Transcranial Magnetic Stimulation Sham

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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