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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06945731
Enrollment
50
Registered
2025-04-25
Start date
2022-01-28
Completion date
2026-05-01
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Cravings, Obesity and Overweight

Brief summary

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.

Interventions

DEVICETMS

20 sessions 10 Hz rTMS

DEVICETranscranial Magnetic Stimulation Sham

Sham TMS

Sponsors

Larissa University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BMIFrom enrollment to the end of the treatment at 5 weeks, follow up of 1 month and 6 months
Food CravingFrom enrollment to the end of the treatment at 5 weeks, follow up of 1 month and 6 monthsScale: Food Cravings Questionnaire-Trait Scores: 15-90 Higher score means worsening of symptoms

Secondary

MeasureTime frameDescription
Depressive SymptomsFrom enrollment to the end of the treatment at 5 weeks, follow up of 1 month and 6 monthsScale Patient Health Questionnaire 9 Scores 0-27 Higher Score means worsening of symptoms
Anxiety symptomsFrom enrollment to the end of the treatment at 5 weeks, follow up of 1 month and 6 monthsGeneralised Anxiety Disorder Questionnaire 7 Scores 0-21 Higher Score means worsening of symptoms
Psychosomatic symptomsFrom enrollment to the end of the treatment at 5 weeks, follow up of 1 month and 6 monthsScale Patient Health Questionnaire 15 Scores 0-30 Higher Score means worsening of symptoms

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026