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Transcranial Magnetic Stimulation in Depression. (LiTMS)

4 de junio de 2026 actualizado por: Blanca Olivia Murillo Ortiz, Instituto Mexicano del Seguro Social

Effect of Low-intensity Transcranial Magnetic Stimulation (Li-TMS) on Sleep Disorders, Inflammation Levels, and Brain-derived Neurotrophic Factor in Patients With Depression.

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.

Descripción general del estudio

Descripción detallada

In low- and middle-income countries, only 25% of patients diagnosed with depression receive some form of treatment, with the current options being standard drug therapy and/or psychotherapy (WHO, 2023) (1). However, only about 35% of patients achieve complete remission of symptoms, resulting in more than half of patients with treatment-resistant depression (4).

Several studies have evaluated the efficacy of bilateral high-frequency (10 Hz) (5,6) and low-frequency (1 Hz) (50) Li-TMS applied to the dorsolateral prefrontal cortex (DLPFC) in patients with depression and insomnia over a 6-week period, totaling 30 sessions. These studies showed improvement in depressive symptoms and sleep quality in adults beginning at session 10 (5) and 15, respectively, as assessed by the Pittsburgh Sleep Quality Index (PSQI) and the Patient Health Questionnaire-9 (PHQ9) (7).

The exact mechanism by which Li-TMS improves sleep quality in patients with depression remains unclear. However, evidence indicates that patients who underwent high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) demonstrate improvement in sleep patterns, improvement in sleep stage, positive correlations in motor evoked potential, negative correlations with GABA and BDNF levels, as well as decreased levels of thyroid hormone, adrenocorticotropic hormone, and thyroid-stimulating hormone (5).

Tipo de estudio

Intervencionista

Inscripción (Actual)

40

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Guanajuato
      • León, Guanajuato, México, 37328
        • 1Clinical Epidemiology Research Unit. OOAD Guanajuato. Mexican Social Security Institute, Leon, Mexico,

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Clinical diagnosis of major depressive disorder
  • insomnia

Exclusion Criteria:

  • Epilepsy
  • Alzheimer's Disease

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador falso: group of sham-treated patients
The Sham group was 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.
Comparador activo: Group receive low-intensity transcranial magnetic stimulation (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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Changes in depressive symptoms following 20 sessions of transcranial magnetic stimulation.
Periodo de tiempo: From the start of treatment until 4 weeks after it ends.

The Hamilton Scale assesses the severity of depression or anxiety using scores that classify symptoms as mild, moderate, or severe, consists of 17 items that assess aspects such as mood, anxiety, insomnia, loss of interest, and somatic symptoms. Each item is scored between 0 and 2 or 0 and 4, depending on the symptom. The total score is obtained by adding the values of all items, with a typical range of 0 to 52 points.

Interpretation of HAM-D Scores: 0-7 points: No depression. 8-13 points: Mild depression.14-18 points: Moderate depression 19-22 points: Severe depression >23 points: Very severe depression, with risk of suicide.

The scale also allows for monitoring changes in symptoms over time, evaluating response to treatment or remission of depression. A decrease of at least 50% from the initial score indicates a response to treatment, and scores below-7 suggest remission.

From the start of treatment until 4 weeks after it ends.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Blanca Olivia Murillo Ortiz, PhD, Mexican Social Security Institute

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

6 de enero de 2025

Finalización primaria (Actual)

25 de julio de 2025

Finalización del estudio (Actual)

18 de mayo de 2026

Fechas de registro del estudio

Enviado por primera vez

18 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

4 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IMSS1
  • R-2024-785-075 (Identificador de registro: National Scientific Research Commission)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

The data will be accessible in a properly anonymized form, as the confidential information is protected and cannot be used to identify participants. However, the results are available upon formal request.

Marco de tiempo para compartir IPD

June 2026 to June 2028

Criterios de acceso compartido de IPD

The dataset may be shared upon request by researchers interested in the research project, via the corresponding author's email address.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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