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Parkinsonian Syndromes (PDS) with predominant motor dysfunction include progressive supranuclear palsy (PSP), multiple system atrophy (MSA) and corticobasal degeneration (CBD). Current treatment options for PDS are extremely limited due to the less understanding of disease pathophysiology and lack of therapeutic targets. Combining the results of previous studies and our group's previous research, sixty qualified PDS patients would be enrolled to conduct a prospective single-center randomized sham controlled clinical trial to verify the new therapeutic options that can improve symptoms and effectively slow the progression of the disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| muti-site stimulation group1 | Active Comparator | The intervention period: 2 weeks muti-site: individual target (iTBS OR cTBS) / M1 (iTBS) |
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| single-site stimulation group2 | Active Comparator | The intervention period: 2 weeks muti-site: individual target (sham) / M1 (iTBS) |
|
| sham stimulation group3 | Sham Comparator | The intervention period: 2 weeks muti-site: individual target (sham) / M1 (sham) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromodulation | Device | Noninvasive brain stimulation (NIBS) includes a variety of noninvasive neuromodulation techniques such as transcranial magnetic stimulation (TMS), transcranial direct current stimulation (TDCS), and so on. Theta burst stimulation(TBS) is a new form of excitatory or inhibitory 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- treatment in the three intervention groups (UPDRS part3: range 0~72, higher score is related to a worse outcome). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Group differences of Progressive Supranuclear Palsy Rating Scale (PSPRS) | Compare the changes in PSPRS scores from baseline to post- treatment in the three intervention groups (psp patients specific). | 6 weeks |
| Group differences of Unified Multiple System Atrophy Rating Scale (UMSARS) |
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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 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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|
Compare the changes in UMSARS scores from baseline to post- treatment in the three intervention groups (MSA patients specific). |
| 6 weeks |
| Group differences of Cortical Basal ganglia Functional Scale (CBFS) | Compare the changes in CBFS scores from baseline to post- treatment in the three intervention groups (cbd patients specific). | 6 weeks |
| Group differences of Berg Balance Scale (BBS) changes | Compare the changes in BBS scores from baseline to post-treatment in the three intervention groups (BBS: range 0~56, higher score is related to a better outcome). | 6 weeks |
| Group differences of Hamilton depression scale-17 (HAMD-17) changes | Compare the changes in HAMD-17 scores from baseline to post-treatment in the three intervention groups (HAMD-17: range 0~38, higher score is related to a worse outcome). | 6 weeks |
| Group differences of Hamilton Anxiety Scale (HAMA) changes | Compare the changes in HAMA scores from baseline to post-treatment in the three intervention groups (HAMA: range 0~64, higher score is related to a worse outcome). | 6 weeks |
| Group differences of Mini-mental State Examination (MMSE) changes | Compare the changes in MMSE scores from baseline to post-treatment in the three intervention groups (MMSE: range 0~30, higher score is related to a better outcome). | 6 weeks |
| Group differences of Montreal Cognitive Assessment (MoCA) changes | Compare the changes in MoCA scores from baseline to post-treatment in the three intervention groups (MoCA: range 0~30, higher score is related to a better outcome). | 6 weeks |
| Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes | Compare the changes in PDQ-39 scores from baseline to post-treatment in the three intervention groups (PDQ-39: range 0~156, higher score is related to a worse outcome). | 6 weeks |
| Group differences of Wexner scores changes | Compare the changes in Wexner scores from baseline to post-treatment in the three intervention groups (Wexner: range 0~30, higher score is related to a worse outcome). | 6 weeks |
| Group differences of Standardized Swallowing Assessment (SSA) changes | Compare the changes in SSA from baseline to post-treatment in the three intervention groups | 6 weeks |
| Group differences of adverse event | Compare the changes in adverse event in the three intervention groups | 6 weeks |
|
| D009069 | Movement Disorders |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |