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

NCT07218952 | Enrolling By Invitation FDA Device

• 1 other identifier: 24-006978
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

anti-inflammatory; neurodegenerative disease; radiation; low-dose

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) score

  Baseline, 3 months, 6 months

• Change in Parkinson's Disease Questionnaire (PDQ-39) Score

  Baseline, 3 months, 6 months

Study Arms (1)

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.

Radiation: Radiation therapy

Interventions

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.

Also known as: LINAC TrueBeam Radiation Therapy System

Radiation Therapy

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Neurodegenerative Diseases

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yasamin Sharifzadeh-Moghaddam

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: October 21, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)