RecruitingPhase 1Phase 2NCT06667180

Effects of Low-intensity Transcranial Magnetic Stimulation on Major Depressive Disorder, and on 5-hydroxyindoleacetic Acid and Brain-derived Neurotrophic Factor Levels


Sponsor

Universidad de Guanajuato

Enrollment

40 participants

Start Date

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomised clinical trial is to evaluate the effects of transcranial magnetic stimulation (TMS) on major depressive disorder (MDD) and on the levels of 5-hydroxyindoleacetic acid (5-HIAA) and brain-derived neurotrophic factor (BDNF). TMS works to treat MDD by using low-intensity magnetic fields to modulate certain areas of the brain, activating them which can help improve the mood of those suffering from the disorder. Final metabolites of serotonin such as 5-HIAA and growth factors such as BDNF will also be studied before starting the intervention and at the end to check if there is a significant change in their concentration. Likewise, its safety will be evaluated by monitoring the symptoms that they present at the end of the intervention and one month later. The main questions that are intended to be answered are: * Does low-intensity TMS reduce depressive symptoms in patients with MDD? * Does low-intensity TMS significantly change the initial and final concentrations of 5-HIAA and BDNF? * What adverse effects might patients who are exposed to low-intensity TMS experience? The researchers will compare low-intensity and accelerated TMS with sham TMS to see if low-intensity TMS works to treat MDD. Participants: * Will undergo an initial clinical assessment to confirm the disorder, comorbidities, and general health status. * A 5 mL blood sample will be taken before starting the intervention. * Low-intensity TMS will be applied for 4 days, 5 daily sessions of 200 s with 10-minute intersession intervals at a field intensity of 2-4 milliTesla (mT) and frequency of 50 Hz in theta bursts. Symptoms will be monitored daily. * A 5 mL blood sample will be taken at the end of the intervention and general health status clinimetrics will be reapplied.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether a gentle form of brain stimulation called low-intensity transcranial magnetic stimulation (TMS) — a non-invasive technique that uses magnetic pulses near the head — can improve symptoms of major depressive disorder and affect certain brain chemical levels. **You may be eligible if...** - You are between 18 and 60 years old - You have been diagnosed with major depressive disorder by a psychiatrist - You are currently undergoing treatment and attending follow-up appointments - You have no history of epilepsy, schizophrenia, or brain surgery - You do not have metal implants in your skull, neck, chest, or shoulders - You do not use a pacemaker or hormone replacement therapy **You may NOT be eligible if...** - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELow-intensity TMS

Low-intensity TMS will be applied for 4 days, 5 daily sessions of 200 s with 10-minute intersession intervals at a field intensity of 2-4 mT and frequency of 50 Hz in theta bursts.

DEVICETranscranial Magnetic Stimulation Sham

The control group will receive the simulation of low-intensity TMS without magnetic field induction.


Locations(1)

High Specialty Medical Unit No. 1, Bajío. Mexican Social Security Institute

León, Guanajuato, Mexico

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NCT06667180


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