Ultra-low Dose, DaT-SPECT-guided Radiation Therapy for the Treatment of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in progression of Parkinson's Disease
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Radiation Therapy
Patients with early-stage, non-genetic, unilateral Parkinson's Disease who will receive an ultra-low, anti-inflammatory dose of radiation therapy.
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Change in progression of Parkinson's Disease
时间窗: 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.
Change in progression of Parkinson's Disease
时间窗: 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.
次要结局
- Change in Parkinson's Disease Questionnaire (PDQ-39) Score(Baseline, 3 months, 6 months)
- Change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) score(Baseline, 3 months, 6 months)
研究者
Yasamin Sharifzadeh-Moghaddam
Principal Investigator
Mayo Clinic