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The purpose of this study is to investigate the use of ultra-low, anti-inflammatory doses of radiation therapy (RT) for the treatment of Parkinson's Disease (PD). In this study, the TrueBeam LINAC utilizes a linear accelerator (LINAC) for the delivery of radiation therapy. Dynamic conformal arc (DCA) therapy will be used to deliver a total of five (5) once-a-day radiation treatments (RT) using DaT-SPECT (Dopamine Transporter-Single-Photon Emission Computed Tomography) and MRI imaging to guide radiation treatment planning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation Therapy | Experimental | Patients with early-stage, non-genetic, unilateral Parkinson's Disease who will receive an ultra-low, anti-inflammatory dose of radiation therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation therapy | Radiation | Dynamic conformal arc (DCA) therapy will be used to deliver a total of five (5) 60cGy once-a-day radiation treatments (RT) using DaT-SPECT (Dopamine Transporter-Single-Photon Emission Computed Tomography) and MRI imaging to guide radiation treatment planning. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in progression of Parkinson's Disease | Slowing of progression will be defined as a 7-point decrease in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination (physician-assessed motor symptoms) score. The score for this scale ranges from 0 to 132, with higher numbers indicating worse disease. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) score | The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III is a physician assessed motor examination that scores symptoms on a 0-4 scale, where 0 is normal and 4 is marked severity. The total Part III score is the sum of individual item scores. Higher scores indicate a greater severity of motor deficits. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Yasamin Sharifzadeh-Moghaddam | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D019636 | Neurodegenerative Diseases |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Baseline, 3 months, 6 months |
| Change in Parkinson's Disease Questionnaire (PDQ-39) Score | The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire that assesses the impact of Parkinson's disease on quality of life. Each item is rated on a 5-point scale: 0: never, 1: occasionally, 2: sometimes, 3: often, and 4: always. The total score ranges from 0 (no impact) to 392 (severe impact). | Baseline, 3 months, 6 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |