Radiation Therapy (RT) for Parkinson's Disease (PD)

N/AEnrolling By InvitationNCT07218952

Mayo Clinic20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson's Disease

Interventions

Radiation therapyRADIATION

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.

Eligibility

Sex: ALLMin age: 45 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 6 months

Secondary Outcomes

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.

Time frame: 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).

Time frame: Baseline, 3 months, 6 months

Data from ClinicalTrials.gov

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