Actively Recruiting
Effects of Low-intensity Transcranial Magnetic Stimulation on Major Depressive Disorder and on 5-hydroxyindoleacetic Acid and Brain-derived Neurotrophic Factor Levels
Led by Universidad de Guanajuato · Updated on 2025-05-08
40
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
Sponsors
U
Universidad de Guanajuato
Lead Sponsor
I
Instituto Mexicano del Seguro Social
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of low-intensity transcranial magnetic stimulation (TMS) on major depressive disorder (MDD), along with its impact on levels of 5-hydroxyindoleacetic acid (5-HIAA) and brain-derived neurotrophic factor (BDNF). This randomized clinical trial aims to determine whether low-intensity TMS can reduce depressive symptoms and cause significant changes in these blood markers. The safety of TMS will also be assessed by monitoring symptoms during and after the treatment period. Participants will be randomly assigned to receive either real low-intensity TMS or a sham (simulated) TMS. The real TMS treatment involves 4 days of therapy with 5 daily sessions lasting 200 seconds each, spaced by 10-minute breaks. The magnetic field intensity used ranges from 2 to 4 milliTesla, delivered at 50 Hz in theta bursts. The sham group receives simulated treatment without magnetic field induction. During the study, participants will undergo an initial clinical assessment and provide a 5 mL blood sample before treatment. Symptoms will be monitored daily throughout the 4-day intervention. At the end, another blood sample will be collected and clinical assessments repeated. Safety monitoring will continue for one month after treatment to observe any adverse effects. The total participation includes the 4-day intervention and the follow-up period for symptom evaluation.
CONDITIONS
Brief Title
Effects of Low-intensity Transcranial Magnetic Stimulation on Major Depressive Disorder, and on 5-hydroxyindoleacetic Acid and Brain-derived Neurotrophic Factor Levels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- Both sexes
- Diagnosis of major depressive disorder confirmed by a psychiatrist
- Continuing treatment and attending follow-up consultations at the health facility
- No history of epilepsy, schizophrenia, or neurosurgeries
- No metal plates in the skull, neck, chest, or shoulder
- No use of pacemakers
- No use of hormone substitutes
- Agreement to participate in the research
You will not qualify if you...
- Pregnant individuals
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 days
Participants receive either low-intensity transcranial magnetic stimulation or a sham simulation over 4 days.
5 daily sessions
Duration - 1 month
Participants are monitored for improvement in symptoms of depression up to one month after the end of treatment.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
High Specialty Medical Unit No. 1, Bajío. Mexican Social Security Institute
León, Guanajuato, Mexico, 37328
Actively Recruiting
Research Team
O
Olga E Escobar Florez, Master of Medical Sciences
M
Ma. Eugenia Garay Sevilla, Medical Sciences PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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