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

Universidad de Guanajuato

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Transcranial Magnetic Stimulation; Placebo; Depression - Major Depressive Disorder

Treatments: Device: Low-intensity TMS; Device: Transcranial Magnetic Stimulation Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT06667180

R-2024-785-001 (Registry Identifier)

CEPIUG-P35-2023

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 60 years.
• Both sexes.
• Those who have a diagnosis of MDD previously made by the treating psychiatrist (considering time since diagnosis and recurrence of episodes).
• Those who continue with their respective treatment and attend follow-up consultations at the health facility.
• Those who do not have a history of epilepsy, schizophrenia, neurosurgeries.
• Those who do not have metal plates anywhere in the skull, neck, chest and shoulder.
• Those who do not use pacemakers.
• Those who do not take hormone substitutes.
• Those who agree to participate in the research.

Exclusion criteria

• Those who are pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Low-intensity TMS

Experimental group

Description:

This group will receive the real low-intensity TMS

Treatment:

Device: Low-intensity TMS

Sham low-intensity TMS

Placebo Comparator group

Description:

This group will receive the simulation of the low-intensity TMS

Treatment:

Device: Transcranial Magnetic Stimulation Sham