Comparison of Different Acceleration Modes of Transcranial Magnetic Stimulation

NCT ID: NCT06881030

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-25

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Treatment Resistant Depression (TRD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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HL intervention group

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.

Group Type ACTIVE_COMPARATOR

Noninvasive transcranial magnetic stimulation was administered 10 times daily

Intervention Type PROCEDURE

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.

TT intervention group

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.

Group Type EXPERIMENTAL

Noninvasive transcranial magnetic stimulation was administered six times daily

Intervention Type PROCEDURE

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.

sham group

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.

Group Type SHAM_COMPARATOR

Sham

Intervention Type PROCEDURE

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.

Interventions

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Noninvasive transcranial magnetic stimulation was administered six times daily

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.

Intervention Type PROCEDURE

Noninvasive transcranial magnetic stimulation was administered 10 times daily

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.

Intervention Type PROCEDURE

Sham

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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[2025C]IIT. No. 026

Identifier Type: -

Identifier Source: org_study_id

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