Transcranial Magnetic Stimulation in Depression.

NCT07638202 | Completed

• 2 other identifiers: IMSS1R-2024-785-075
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major Depressive Disorder (MDD)

Keywords

low-intensity transcranial magnetic stimulation; Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Changes in depressive symptoms following 20 sessions of transcranial magnetic stimulation.

  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.

Study Arms (2)

group of sham-treated patients

SHAM COMPARATOR

The Sham group was administered standard drug therapy with coil placement, without exposure to Li-TMS emission.

Other: control group B were administered standard drug therapy with coil placement, without exposure to Li-TMS emission.

Group receive low-intensity transcranial magnetic stimulation (Li-TMS)

ACTIVE COMPARATOR

Group receive low-intensity transcranial magnetic stimulation (Li-TMS)

Other: The experimental group(A) received conventional drug treatment combined with Li-TMS.

Interventions

The experimental group(A) received conventional drug treatment combined with Li-TMS. OTHER

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.

Group receive low-intensity transcranial magnetic stimulation (Li-TMS)

control group B were administered standard drug therapy with coil placement, without exposure to Li-TMS emission. OTHER

the control group were administered standard drug therapy with coil placement, without exposure to Li-TMS emission.

group of sham-treated patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of major depressive disorder
• insomnia

You may not qualify if:

• Epilepsy
• Alzheimer's Disease

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

1Clinical Epidemiology Research Unit. OOAD Guanajuato. Mexican Social Security Institute, Leon, Mexico,

León, Guanajuato, 37328, Mexico

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Blanca Olivia Murillo Ortiz, PhD

  Mexican Social Security Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding was performed in patients who did not know whether or not they would receive treatment with low-intensity transcranial magnetic stimulation (Li-TMS). The groups were selected at random.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD MD Blanca Olivia Murillo Ortiz

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: June 10, 2026
• Study Start: January 6, 2025
• Primary Completion: July 25, 2025
• Study Completion: May 18, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: June 2026 to June 2028
• Access Criteria: The dataset may be shared upon request by researchers interested in the research project, via the corresponding author's email address.

Locations

ME (1)