Precision Transcranial Magnetic Stimulation for Depression Based on Orbital Frontal Cortex-habenula Circuitry
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorXijing Hospital
About this trial
Thirty depressed patients will be recruited to select individualized transcranial magnetic stimulation targets based on individual orbital frontal cortex and habenula functional activity connectivity for 10 or 20 treatments to assess the efficacy and safety of this intervention
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gender is not limited, age 18～60 years old;
Comply with the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) of the United States of America;
Hamilton rating scale for depression (HAMD) 17-item score ≥ 18;
The medication/psychotherapy received by the subject prior to the start of the study remained stable for at least 4 weeks .
Disqualifiers
History of serious somatic diseases or diseases that may affect the central nervous system (e.g., tumors, syphilis, etc.);
Neurological disorders or risk of seizures, such as previous craniosynostosis, head trauma, alcoholism, abnormal electroencephalograms, MRI evidence of structural abnormalities in the brain, or family history of epilepsy;
Patients with bipolar disorder and depression due to other psychiatric disorders (e.g., psychoactive and non-dependent substances);
Contraindications to MRI scanning or transcranial magnetic stimulation therapy, such as metal or electronic devices placed in the body (intracranial metal foreign bodies, cochlear implants, pacemakers and stents and other metal foreign bodies), space phobia;
Trial design
Design model
Single group
Treatments tested in this trial
transcranial magnetic stimulation
DeviceIndividualized transcranial magnetic stimulation of targets based on the association between the orbitofrontal cortex and the functional activity of the habenula .
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Individualized transcranial magnetic stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to treatment day 10
The Montgomery-Asberg Depression Rating Scale (MADRS) is a widely used clinical assessment tool designed to measure the severity of depressive symptoms.The MADRS consists of 10 items, each of which addresses a different aspect of depression, such as low mood, loss of interest, sleep disorders, appetite, concentration, fatigue, inability to feel pleasure, pessimistic thinking, and suicidal ideation. Each item is scored according to the severity of symptoms, ranging from 0 to 6, with a total score ranging from 0-60, with higher scores indicating more severe depressive symptoms. Change = (treatment day 10 Score -Baseline Score).
Time frame
Baseline and treatment day 10Secondary outcomes
1
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to 28 days after the end of treatment
The Montgomery-Asberg Depression Rating Scale (MADRS) is a widely used clinical assessment tool designed to measure the severity of depressive symptoms.The MADRS consists of 10 items, each of which addresses a different aspect of depression, such as low mood, loss of interest, sleep disorders, appetite, concentration, fatigue, inability to feel pleasure, pessimistic thinking, and suicidal ideation. Each item is scored according to the severity of symptoms, ranging from 0 to 6, with a total score ranging from 0-60, with higher scores indicating more severe depressive symptoms. Change = (28 days after the end of treatment Score -Baseline Score).
Time frame
Baseline and 28 days after the end of treatment2
Change in Hamilton Anxiety Scale scores from baseline to treatment day 10
Hamilton Anxiety Scale (HAMA）is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom. Change = (treatment day 10 Score -Baseline Score).
Time frame
Baseline and treatment day 103
Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment
Hamilton Anxiety Scale (HAMA）is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom. Change = (28 days after the end of treatment Score -Baseline Score).
Time frame
Baseline and 28 days after the end of treatment4
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 10
Hamilton Depression Scale（HAMD-17） is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom. Change = (treatment day 10 Score -Baseline Score).
Time frame
Baseline and treatment day 10Sponsors and contacts
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Source ClinicalTrials.gov
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