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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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-08-01
2024-12-31
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
TREATMENT
DOUBLE
Study Groups
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Early-start single iTBS group
The intensive period: 2 weeks The maintenance period: 12 weeks
intermittent theta burst stimulation
iTBS is a new form of excitatory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.
Early-start double iTBS group
The intensive period: 2 weeks The maintenance period: 12 weeks
intermittent theta burst stimulation
iTBS is a new form of excitatory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.
Delayed-start single iTBS group
The intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks
intermittent theta burst stimulation
iTBS is a new form of excitatory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.
sham iTBS
The pseudo-stimulation device looks and sounds the same as the iTBS device
Delayed-start double iTBS group
The intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks
intermittent theta burst stimulation
iTBS is a new form of excitatory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.
sham iTBS
The pseudo-stimulation device looks and sounds the same as the iTBS device
Interventions
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intermittent theta burst stimulation
iTBS is a new form of excitatory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.
sham iTBS
The pseudo-stimulation device looks and sounds the same as the iTBS device
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged \>20 years and \<80 years, regardless of gender.
* 2 ≤ Hoehn-Yahr stage≤ 4.
* Maintain medication stability during the study period.
* Good compliance, written informed consent, and consent for long-term interventional treatment with iTBS.
Exclusion Criteria
* Patients with significant cognitive impairment (MMSE \< 24) or inability to complete questionnaires independently.
* Prior treatment with TMS, DBS or SCS.
* Severe physical illness and any physical illness that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory disease.
* Have human implantable materials such as intracranial stents, pacemakers, coronary stents, cochlear implants, etc.
* Are currently taking other investigational drugs.
* Any other condition that the investigator deems unsuitable for participation in this study.
20 Years
80 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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Principal Investigators
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Jun Liu, Professor
Role: STUDY_CHAIR
Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Locations
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Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022043
Identifier Type: -
Identifier Source: org_study_id
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