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This study is a prospective, single-center, single-arm early feasibility study, to establish safety and tolerability of LIFU for neuromodulation in patients with parkinson's Disease
The primary objective is to evaluate the safety, feasibility and tolerability of LIFU as an adjunct neuromodulatory treatment for Parkinson's Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIFU Neuromodulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIFU Neuromodulation | Device | Subjects will undergo a single LIFU of the target brain region |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment Emergent Adverse Events | All adverse events that are related to LIFU will be assessed | baseline and day 7, 30 and 90 after study procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of LIFU on visuospatial function, | prosaccade (PST) and antisaccade (AST) task | baseline and day 7, 30 and 90 after study procedure |
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Inclusion Criteria:
Exclusion Criteria:
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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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Single Group Assignment
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |