Comparison of Different Acceleration Modes of Transcranial Magnetic Stimulation
March 17, 2025 updated by: First Affiliated Hospital of Zhejiang University
Comparison of the Efficacy of Different Modes of Accelerated Transcranial Magnetic Stimulation in Treatment-resistant Depression
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 Overview
Status
Not yet recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
45
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The current episode met the DSM-5 diagnostic criteria for major depression, without psychotic symptoms of the first or recurrent drug-free depressive subjects
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
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.
|
|
Experimental: 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.
|
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 Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hamilton Depression Scale (24-items) Total Score Change
Time Frame: Baseline to end of stimulation period, an average of 5 days
|
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.
|
Baseline to end of stimulation period, an average of 5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the rate of Hamilton Anxiety Scale score
Time Frame: Time Frame: Baseline to end of stimulation period, an average of 5 days
|
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: Baseline to end of stimulation period, an average of 5 days
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the rate of Beck Scale of Suicidal Ideation score
Time Frame: Baseline to end of stimulation period, an average of 5 days
|
Beck Scale of Suicidal Ideation is a 21-item self-report instrument that detects and measures the intensity of a patient's specific attitudes, behaviors, and suicide plans during the past week.
The BSI score ranges from 0 to 63, with higher scores indicating worse outcomes and lower scores indicating better outcomes.
|
Baseline to end of stimulation period, an average of 5 days
|
|
Change in neuroimaging using functional magnetic resonance
Time Frame: Baseline to end of stimulation period, an average of 5 days
|
Scanning functional magnetic resonance.
Functional magnetic resonance imaging (fMRI) is a neuroimaging technique that is used to measure changes in brain activity by detecting changes in blood flow.
In the context of major depression, fMRI has been used to study changes in brain function that may be associated with the condition.
Research using fMRI in major depression has shown that there are alterations in the activity of certain brain regions in people with the condition.
|
Baseline to end of stimulation period, an average of 5 days
|
|
Change in electroencephalogram
Time Frame: Baseline to end of stimulation period, an average of 5 days
|
Electroencephalogram is collected from 64 electrodes.
EEG can be used to identify patterns of brain activity that are associated with the condition and to inform treatment decisions.
EEG can be a useful tool for identifying patterns of brain activity that are associated with TRD and for guiding treatment decisions.
Neurofeedback and TMS are two approaches that have shown promise in the treatment of TRD.
several parameters are analyzed to identify patterns of brain activity that may be associated with the condition.
These parameters include:Alpha power, Beta power, Theta power, Delta power,etc.
|
Baseline to end of stimulation period, an average of 5 days
|
|
Change of blood factor levels
Time Frame: Baseline to end of stimulation period, an average of 5 days
|
Factors carried by peripheral blood and exosomes(Hypocretin, Brain-derived neurotrophic fact, Reelin, and N-methyl-D-aspartic acid receptor).
|
Baseline to end of stimulation period, an average of 5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 25, 2025
Primary Completion (Estimated)
August 31, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
March 10, 2025
First Submitted That Met QC Criteria
March 17, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 17, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- [2025C]IIT. No. 026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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