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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early-start single iTBS group | Active Comparator | The intensive period: 2 weeks The maintenance period: 12 weeks |
|
| Early-start double iTBS group | Active Comparator | The intensive period: 2 weeks The maintenance period: 12 weeks |
|
| Delayed-start single iTBS group | Sham Comparator | The intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks |
|
| Delayed-start double iTBS group | Sham Comparator | The intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intermittent theta burst stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Group differences of Berg Balance Scale (BBS) changes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Liu, Professor | Contact | 64370045 | +86-021 | jly0520@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Liu, Professor | Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
No individual participant data (IPD) was available to other researchers.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| sham iTBS | Device | The pseudo-stimulation device looks and sounds the same as the iTBS device |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Group differences of adverse event | Compare the adverse event in four intervention groups. | 28 weeks |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |