Parkinson's DiseaseNCT07218952
Radiation Therapy (RT) for Parkinson's Disease (PD)
A study testing Radiation therapy in people with Parkinson's Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Ultra-low Dose, DaT-SPECT-guided Radiation Therapy for the Treatment of Parkinson's Disease
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
- Being tested
- Radiation therapy
- Keywords
- anti-inflammatory, neurodegenerative disease, radiation, low-dose
- Medical subject headings
- Parkinson Disease, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyRadiation
Also called LINAC TrueBeam Radiation Therapy System
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start20 Jan 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasamin Sharifzadeh-Moghaddam, Mayo Clinic
- Investigators
- Yasamin Sharifzadeh-Moghaddam, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218952
- Sponsor's protocol ID
- 24-006978
- Status last verified
- Jun 2026
- First submitted
- 17 Oct 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-low Dose, DaT-SPECT-guided Radiation Therapy for the Treatment of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07218952
- Acronym / sponsor ID
- 24-006978
- Conditions
- Parkinson's Disease
- Keywords
- anti-inflammatory, neurodegenerative disease, radiation, low-dose
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy | Experimental | Radiation: Radiation therapyPatients with early-stage, non-genetic, unilateral Parkinson's Disease who will receive an ultra-low, anti-inflammatory dose of radiation therapy. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapyAlso: LINAC TrueBeam Radiation Therapy SystemDynamic 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. | Radiation | Radiation Therapy |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yasamin Sharifzadeh-Moghaddam principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation therapy in people with Parkinson's Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in progression of Parkinson's Disease (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.