Comparison of Different Acceleration Modes of Transcranial Magnetic Stimulation

NCT06881030 | Not Yet Recruiting

• 1 other identifier: [2025C]IIT. No. 026
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Treatment Resistant Depression (TRD)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to end of stimulation period, an average of 5 days

Secondary Outcomes (1)

• Change in the rate of Hamilton Anxiety Scale score

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

Other Outcomes (4)

• Change in the rate of Beck Scale of Suicidal Ideation score

  Baseline to end of stimulation period, an average of 5 days

• Change in neuroimaging using functional magnetic resonance

  Baseline to end of stimulation period, an average of 5 days

• Change in electroencephalogram

  Baseline to end of stimulation period, an average of 5 days

Study Arms (3)

HL intervention group

ACTIVE COMPARATOR

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.

Procedure: Noninvasive transcranial magnetic stimulation was administered 10 times daily

TT intervention group

EXPERIMENTAL

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.

Procedure: Noninvasive transcranial magnetic stimulation was administered six times daily

sham group

SHAM COMPARATOR

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.

Procedure: Sham

Interventions

Noninvasive transcranial magnetic stimulation was administered six times daily 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.

TT intervention group

Noninvasive transcranial magnetic stimulation was administered 10 times daily 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.

HL intervention group

Sham 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.

sham group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• item Hamilton depression Scale score ≥20
• The age ranged from 18 to 45 years, both sexes
• Right handed
• Written informed consent was obtained and patients volunteered to participate in the study and be evaluated.

You may not qualify if:

• \. Comorbidity with other mental disorders, including schizophrenia, mental retardation, substance dependence, etc.
• \. Suffering from serious or unstable physical diseases
• , pregnant, lactating women, women of childbearing age screening period urine HCG test results are positive
• \. Subjects with metal objects in the body or other contraindications to MRI scanning
• \. There are other conditions considered by the investigator to be inappropriate for participation in the clinical trial.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 18, 2025
• Study Start: March 25, 2025
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03