Comparison of Different Acceleration Modes of Transcranial Magnetic Stimulation

N/ANot Yet RecruitingNCT06881030

First Affiliated Hospital of Zhejiang University45 enrolled

Overview

To compare the efficacy and safety of 6 times a day, 10 times a day acceleration mode and sham stimulation intervention for TRD, and to explore the antidepressant mechanism of accelerated mode, so as to provide a more simple and effective rapid treatment plan for TRD patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Treatment Resistant Depression (TRD)

Interventions

Noninvasive transcranial magnetic stimulation was administered six times dailyPROCEDURE

The motor threshold of 100% intensity, a TBS stimulus train for 2 seconds, including 10 times of 3 intrapascicular stimulation at 50 Hz and interapascicular stimulation at 5HZ, intervals of 10s, 60 repetitions, that is, a total of 1800 pulses per treatment, 6 treatments per day, 50 min apart, a total of 10800 pulses/day, continuous stimulation for 5 days.

Noninvasive transcranial magnetic stimulation was administered 10 times dailyPROCEDURE

The motor threshold of 100% intensity, a TBS stimulus train stimulation for 2 seconds, including 10 times of 3 intrapascicular stimulation at 50 Hz and interapascicular stimulation at 5HZ, intervals of 10s, 60 repetitions, that is, a total of 1800 pulses per treatment, 10 treatments per day, intervals of 50 min, a total of 18000 pulses/day, continuous stimulation for 5 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The current episode met the DSM-5 diagnostic criteria for major depression, without psychotic symptoms of the first or recurrent drug-free depressive subjects 2. After a full course of treatment with two or more antidepressants, the patient had no response, and the level of treatment resistance was moderate to severe as assessed by the Maudsley staging method 3.24-item Hamilton depression Scale score ≥20 4.The age ranged from 18 to 45 years, both sexes 5.Right handed 6.Written informed consent was obtained and patients volunteered to participate in the study and be evaluated. Exclusion Criteria: * 1\. Comorbidity with other mental disorders, including schizophrenia, mental retardation, substance dependence, etc. 2\. Suffering from serious or unstable physical diseases 3, pregnant, lactating women, women of childbearing age screening period urine HCG test results are positive 4\. Subjects with metal objects in the body or other contraindications to MRI scanning 5\. There are other conditions considered by the investigator to be inappropriate for participation in the clinical trial.

Outcomes

Primary Outcomes

Hamilton Depression Scale (24-items) Total Score Change

The Hamilton Depression Scale (24-items), is a 24 item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. It's considered the gold standard for rating depression severity and used frequently in clinical trials. Higher HAM-D24 score indicates more severe depression, and each item yields a score of 0 to 4. Remission is defined as HAM-D24 ≤8. A reduction of 50% or more in total score from Baseline indicates clinical response.

Time frame: Baseline to end of stimulation period, an average of 5 days

Secondary Outcomes

Change in the rate of Hamilton Anxiety Scale score

Hamilton Anxiety Scale is a 17 item diagnostic questionnaire used to measure the severity of anxiety episodes in patients. Each item on the scale is rated on a 5-point scale from 0 (not present) to 4 (severe), with the total score ranging from 0 to 68. The HAMA-17 is often used in clinical and research settings to assess the severity of anxiety symptoms and to evaluate the effectiveness of treatments for anxiety. It is a more comprehensive version of the HAMA that includes additional items to capture a broader range of anxiety symptoms.

Time frame: Time Frame: Baseline to end of stimulation period, an average of 5 days

Data from ClinicalTrials.gov

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