Parkinson's Disease
Conditions
Keywords
anti-inflammatory, neurodegenerative disease, radiation, low-dose
Brief summary
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.
Interventions
RADIATIONRadiation therapy
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 45 and ≤ 70 years * Diagnosis of Parkinson's disease by a Movement Disorder Neurologist * Confirmation of unilateral Parkinson's disease by Dopamine Transporter (DaT) scan * A score of 2 or less on the modified Hoehn and Yahr scale * ECOG Performance Status (PS) ≤ 2 (Appendix I). * No known genetic causes or predisposition to Parkinson's disease or related diseases. * Ability to complete questionnaires, neurological exam, and follow-up imaging independently or with assistance * Ability to provide written informed consent * Willing to provide mandatory blood samples for correlative research purposes * Willing to return to enrolling institution for follow-up
Exclusion criteria
* Concomitant dementia diagnosis or concerns of other memory disorder * Parkinson's Disease medication changes within the last 3 months * Receipt of radiation therapy for Parkinson's Disease outside Mayo Clinic, Rochester
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in progression of Parkinson's Disease | Baseline, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) score | Baseline, 3 months, 6 months | 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. |
| Change in Parkinson's Disease Questionnaire (PDQ-39) Score | Baseline, 3 months, 6 months | 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). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYasamin Sharifzadeh-Moghaddam
Mayo Clinic
Outcome results
None listed