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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05445505
Other study ID # 2022043
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date December 31, 2024

Study information

Verified date May 2022
Source Ruijin Hospital
Contact Jun Liu, Professor
Phone 64370045
Email jly0520@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Intermittent theta burst stimulation (iTBS) is an emerging non-invasive neuron regulation technique, which is widely used in neuropsychiatry for a variety of diseases and is widely accepted by patients due to its non-invasive, operable and relatively precise localization. Combining the results of previous studies and our group's previous research, sixty qualified PD patients would be enrolled to conduct a prospective single-center randomized double-blind sham controlled clinical trial to verify the long-term curative effects of iTBS treatment protocol and explore the neuron-protection of iTBS on neuronal loss of PD patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Meet the revised clinical diagnostic criteria for Parkinson's disease of the Movement Disorder Society (MDS) International (2015 version). - 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 severe neuropsychiatric disorders or previous history of severe neurological disorders (e.g., epilepsy, cerebrovascular accidents, etc.) or history of traumatic brain injury or brain surgery. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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

Locations

Country Name City State
China Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes Compare the changes in UPDRS scores from baseline to post-iTBS in the four intervention groups (UPDRS part3: range 0~72, higher score is related to a worse outcome). 28 weeks
Secondary Group differences of Hoehn-Yahr stage Compare the changes in Hoehn-Yahr stage from baseline to post-iTBS in the four intervention groups (H-Y stage: range 0~5, higher score is related to a worse outcome). 28 weeks
Secondary Group differences of Berg Balance Scale (BBS) changes Compare the changes in BBS scores from baseline to post-iTBS in the four intervention groups (BBS: range 0~56, higher score is related to a better outcome). 28 weeks
Secondary Group differences of Hamilton depression scale-17 (HAMD-17) changes Compare the changes in HAMD-17 scores from baseline to post-iTBS in the four intervention groups (HAMD-17: range 0~38, higher score is related to a worse outcome). 28 weeks
Secondary Group differences of Hamilton Anxiety Scale (HAMA) changes Compare the changes in HAMA scores from baseline to post-iTBS in the four intervention groups (HAMA: range 0~64, higher score is related to a worse outcome). 28 weeks
Secondary Group differences of Mini-mental State Examination (MMSE) changes Compare the changes in MMSE scores from baseline to post-iTBS in the four intervention groups (MMSE: range 0~30, higher score is related to a better outcome). 28 weeks
Secondary Group differences of Montreal Cognitive Assessment (MoCA) changes Compare the changes in MoCA scores from baseline to post-iTBS in the four intervention groups (MoCA: range 0~30, higher score is related to a better outcome). 28 weeks
Secondary Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes Compare the changes in PDQ-39 scores from baseline to post-iTBS in the four intervention groups (PDQ-39: range 0~156, higher score is related to a worse outcome). 28 weeks
Secondary Group differences of 16-item Sniffin' Sticks test (SS-16) changes Compare the changes in SS-16 scores from baseline to post-iTBS in the four intervention groups (SS-16: range 0~16, higher score is related to a better outcome). 28 weeks
Secondary Group differences of Wexner changes Compare the changes in Wexner scores from baseline to post-iTBS in the four intervention groups (Wexner: range 0~30, higher score is related to a worse outcome). 28 weeks
Secondary Group differences of adverse event Compare the adverse event in four intervention groups. 28 weeks
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