Comparison of Different Acceleration Modes of Transcranial Magnetic Stimulation

Zhejiang University

Status: Not yet enrolling

Conditions: Treatment Resistant Depression (TRD)

Treatments: Procedure: Noninvasive transcranial magnetic stimulation was administered 10 times daily; Procedure: Noninvasive transcranial magnetic stimulation was administered six times daily; Procedure: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT06881030

[2025C]IIT. No. 026

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

HL intervention group

Active Comparator group

Description:

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.

Treatment:

Procedure: Noninvasive transcranial magnetic stimulation was administered 10 times daily

TT intervention group

Experimental group

Description:

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.

Treatment:

Procedure: Noninvasive transcranial magnetic stimulation was administered six times daily

sham group

Sham Comparator group

Description:

The appearance of the sham stimulation coil was consistent with that of the real stimulation coil, which could simulate the touch and sound of the scalp caused by the real stimulation. The treatment frequency, location, intensity and time of the sham stimulation group were the same as those of the real stimulation group.

Treatment:

Procedure: Sham