Parkinson's Disease: Overall Symptoms Improvement With Transcranial Pulse Stimulation (TPS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Unified Parkinson's Disease Rating Scale (UPDRS)
研究概览
简要总结
The investigators are studying if Transcranial Pulse Stimulation (TPS) can improve various symptoms, including movement problems, thinking abilities, mood, fatigue, freezing while walking, voice quality, and issues with smell and taste. Previous research suggests TPS might help in Alzheimer's disease and could be helpful for Parkinson's as well. Investigators will check if TPS is safe, practical, and if it makes a noticeable difference in these symptoms compared to before the treatment.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of "probable" or "possible" Parkinson's Disease (PD), as defined by the current clinical criteria (52) or as confirmed by a co-investigator neurologist or confirmation via medical records or a letter from a patient's physician.
- •Age from 40 to 90 years old.
- •Disease stages 2 to 4 based on the UPDRS scale subdomain V (or Hoehn and Yahr scale).
- •Taking stable medications for Parkinson's Disease for at least 30 days.
排除标准
- •Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes.
- •History of deep brain stimulation, brain ablation surgeries, or malignant mass brain lesions.
- •History of schizophrenia, bipolar illness, or alcohol/drug abuse within the past six months.
- •Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality.
- •Contraindications to transcranial brain stimulation (i.e., metal objects in the head, metal implanted brain medical devices, cortisone treatments within six weeks before the first stimulation session, central nervous system (CNS) thrombosis, etc).
- •Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease).
- •Contraindications to MRI according to Mass General Brigham screening in the Martinos Center (i.e., pacemaker, defibrillator or wires other than sternal wires, metallic foreign body in the eye, or drug infusion devices - if the models of these devices are not compatible with MRI).
- •Epilepsy or disorders that significantly increase the likelihood of seizures, including: (i) severe traumatic brain injury; (ii) congenital birth defects leading to seizures; (iii) brain tumor; (iv) metabolic disorders associated with seizures; (v) intracranial or subarachnoid hemorrhage; and (vi) non-lacunar strokes.
- •Bed- or wheelchair-bound patients.
研究组 & 干预措施
TPS
干预措施: Transcranial Pulse Stimulation (TPS) (Device)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (UPDRS)
时间窗: Baseline and 4 weeks, immediately post-intervention (Visit 12).
Unified Parkinson's Disease Rating Scale (UPDRS) evaluates the motor function, non-motor symptoms (mentation, behavior, and mood), activities of daily living, and complications of therapy. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total UPDRS score is obtained by summing Parts I-IV, with a total score ranging from 0 to 199. Lower scores indicate less severe Parkinson's disease and represent a better outcome; higher scores indicate greater disease severity and represent a worse outcome. The outcome measure represents the change from Baseline to 4 weeks, immediately post-intervention (Visit 12).
次要结局
未报告次要终点
研究者
Felipe Fregni, MD, PhD, MPH
Director of the Neuromodulation Center, Professor of Rehabilitation
Spaulding Rehabilitation Hospital