Radiation Therapy (RT) for Parkinson's Disease (PD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiation therapy.
- Who it may be relevant to
- Registry conditions: Parkinson's Disease. Basic parameters: 45 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ultra-low Dose, DaT-SPECT-guided Radiation Therapy for the Treatment of Parkinson's Disease
Overview
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
- Radiation Radiation 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.
Primary outcome measures
- Change in progression of Parkinson's Disease [Time frame: Baseline, 6 months]
Secondary outcome measures (2)
- Change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) score [Time frame: Baseline, 3 months, 6 months]
- Change in Parkinson's Disease Questionnaire (PDQ-39) Score [Time frame: Baseline, 3 months, 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07218952 · 24-006978