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The primary objective of this clinical study is to evaluate the therapeutic efficacy of Temporal Interference Stimulation (TIS), a non-invasive deep brain stimulation technique, in patients with Parkinson's disease, and to further investigate its potential mechanisms of action. Although TIS offers lower stimulation intensity and precision compared to conventional Deep Brain Stimulation (DBS), it possesses the distinct advantage of being non-invasive. This study utilizes TIS to explore different stimulation targets analogous to those used in DBS for Parkinson's disease, thereby providing valuable insights for subsequent DBS surgical interventions. The findings will contribute preliminary exploratory evidence regarding the application of non-invasive deep brain stimulation technology in the treatment of Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A:STN | Experimental | The subthalamic nucleus (STN) stimulation target |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TIS | Device | Temporal Interference Stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| UPDRS-3 | Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) scores from baseline to immediately after and 1 month after a single treatment session. | From enrollment through the 3-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 4, 2025 | Dec 16, 2025 | Prot_SAP_ICF_000.pdf |
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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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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |