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Transcranial Magnetic Stimulation in Depression.
Sponsor: Instituto Mexicano del Seguro Social
Summary
Major depressive disorder (MDD) has increased in recent years, affecting 16.1% of the adult population nationwide. Currently, there are pharmacological and psychological treatments that have a 67% remission rate for depressive symptoms and insomnia after up to four trials of antidepressant treatments. Recently, low-intensity transcranial magnetic stimulation (Li-TMS) has been used to activate and generate structural and neural functioning changes in specific cortical regions such as the left dorsolateral prefrontal cortex, as its activity is altered in MDD. Furthermore, an increase in circulating levels of granulocytes, monocytes, and inflammatory cytokines has been observed in patients with MDD, suggesting an association between inflammation and neurotoxicity with the development of depression and decreased BDNF, mainly affecting the prefrontal cortex and hippocampus. Therefore, it has been proposed to quantify markers of systemic inflammation and evaluate their correlation with MDD and their possible effect with Li-TMS. This was a probabilistic, two-arm, block-randomized, single-blind clinical trial. A qualified psychiatrist evaluated the patients according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) to confirm the diagnosis of major depressive disorder. Two groups were formed and randomly assigned to receive treatment: transcranial magnetic stimulation or the sham group. The patients were unaware of the treatment; they did not know whether they would receive low-intensity transcranial magnetic stimulation (Li-TMS) or not. It was a clinical trial, two arms, probabilistic, block randomized, single-blind. The experimental group received conventional drug treatment combined with Li-TMS, and the control group was administered standard drug therapy with coil placement, without exposure to Li-TMS emission. Both groups had the device coils placed on them.
Official title: Effect of Low-intensity Transcranial Magnetic Stimulation (Li-TMS) on Sleep Disorders, Inflammation Levels, and Brain-derived Neurotrophic Factor in Patients With Depression.
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-01-06
Completion Date
2026-05-18
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
The experimental group(A) received conventional drug treatment combined with Li-TMS.
20 sessions of Li-TMS with the medical device Nibbot Pro Series. Each Li-TMS session consisted in positioning an eight-shaped coil over the left dorsolateral prefrontal cortex (L-DLPFC) which dispensed magnetic pulses at 25 Hz, (30 mT) for 45 minutes. Subjects received one Li-TMS session daily, from Monday through Friday. The experimental group received conventional drug treatment combined with Li-TMS, and the control group were administered standard drug therapy with coil placement, without exposure to Li-TMS emission. Both groups had the device coils placed on them. At the end of the study, the control group received Li-TMS treatment.
control group B were administered standard drug therapy with coil placement, without exposure to Li-TMS emission.
the control group were administered standard drug therapy with coil placement, without exposure to Li-TMS emission.
Locations (1)
1Clinical Epidemiology Research Unit. OOAD Guanajuato. Mexican Social Security Institute, Leon, Mexico,
León, Guanajuato, Mexico