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Enrolling by Invitation

NCT Number: NCT07218952

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

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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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: LINAC TrueBeam Radiation Therapy System

Primary outcomes

  1. Change in progression of Parkinson's Disease

    Time frame: 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 outcomes

  1. 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

    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.

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Ultra-low Dose, DaT-SPECT-guided Radiation Therapy for the Treatment of Parkinson's Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 21, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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