Effects of Low-intensity Transcranial Magnetic Stimulation on Major Depressive Disorder, and on 5-hydroxyindoleacetic Acid and Brain-derived Neurotrophic Factor Levels
NCT ID: NCT06667180
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2024-10-28
2025-08-26
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low-intensity TMS
This group will receive the real low-intensity TMS
Low-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.
Sham low-intensity TMS
This group will receive the simulation of the low-intensity TMS
Transcranial Magnetic Stimulation Sham
The control group will receive the simulation of low-intensity TMS without magnetic field induction.
Interventions
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Low-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.
Transcranial Magnetic Stimulation Sham
The control group will receive the simulation of low-intensity TMS without magnetic field induction.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Universidad de Guanajuato
OTHER
Responsible Party
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Olga Estefania Escobar Florez
Principal investigator
Principal Investigators
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Ma. Eugenia Garay Sevilla, PhD in medical sciences
Role: STUDY_DIRECTOR
Universidad de Guanajuato
José M De la Roca Chiapas, PhD in medical sciences
Role: STUDY_DIRECTOR
Universidad de Guanajuato
Blanca O Murillo Ortíz, PhD in medical sciences
Role: STUDY_DIRECTOR
Universidad de Guanajuato
Angélica Hernández Rayas, Physics PhD
Role: STUDY_CHAIR
Universidad de Guanajuato
Olga E Escobar Florez, Master of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Universidad de Guanajuato
Locations
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High Specialty Medical Unit No. 1, Bajío. Mexican Social Security Institute
León, Guanajuato, Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R-2024-785-001
Identifier Type: REGISTRY
Identifier Source: secondary_id
CEPIUG-P35-2023
Identifier Type: -
Identifier Source: org_study_id
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