The Mechanisms of Underlying Accelerated Repetitive Transcranial Magnetic Stimulation for Treatment-resistant Depression
NCT ID: NCT05607654
Last Updated: 2023-01-13
Study Results
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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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-01-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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active iTBS
The active group of TRD will receive the accelerated intermittent TBS(iTBS).The iTBS cycles including 10 bursts of three pulses at 50 Hz were delivered in 2-second trains. Each iTBS session comprised 60 x 2 second trains, with an 8-second intertrain interval and total duration of 10-minutes.Treatment sessions were administered hourly 10 times a day totaling 18,000 pulses/day. Patients received this treatment protocol for 5 consecutive days (90,000 pulses in total).
active iTBS
Participants in the active stimulation group will receive the accelerated intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the neuronavigation system. Stimulation intensity will be standardized at 90% of RMT.
Stimulation will be delivered to the L-DLPFC using an NTK-TMS-II100 TMS device,is compatible with the Brainsight TMS navigation system.
sham rTMS
The sham group of TRD will receive sham rTMS stimulation.
sham rTMS
The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
Interventions
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active iTBS
Participants in the active stimulation group will receive the accelerated intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the neuronavigation system. Stimulation intensity will be standardized at 90% of RMT.
Stimulation will be delivered to the L-DLPFC using an NTK-TMS-II100 TMS device,is compatible with the Brainsight TMS navigation system.
sham rTMS
The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
Eligibility Criteria
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Inclusion Criteria
2. 24-item Hamilton Depression Scale (HAMD-24) ≥ 20.
3. Age 18-45 years, regardless of gender.
4. Right-handedness.
5. Han Chinese.
6. Signed a written informed consent, willing to participate in the study and be evaluated.
Exclusion Criteria
2. Patients with metal objects in the body or with other contraindications to MRI scanning
3. Patients with severe or unstable somatic diseases
4. Women during pregnancy or lactation, and women of childbearing age with positive urine HCG test results during the screening period
5. Other conditions that, in the opinion of the investigator, exist that make participation in this clinical trial inappropriate.
18 Years
45 Years
ALL
Yes
Sponsors
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First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Locations
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The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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82271562
Identifier Type: -
Identifier Source: org_study_id
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