Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in Unified Parkinson's Disease Rating Scale (UPDRS) Part III
研究概览
简要总结
This trial aims to understand the mechanism and to test whether transcranial direct current stimulation (tDCS) combined with transcranial ultrasound (TUS) (tDCS+TUS) combined with physical therapy (PT) will induce significant therapeutic effects in postural instability in Parkinson's disease (PT) patients. The investigators designed a double-blinded, placebo controlled, randomized study to investigate the effects of 2 weeks of TDCS+TUS on postural instability in PD patients receiving PT. (Followed by biweekly sessions for 2 more weeks in Phase II)
详细描述
Current treatments for Parkinson's Disease (PD), including pharmacological (levodopa) and surgical (DBS) methods, have limited impact on postural instability. Physical therapy (PT) for PD is becoming increasingly used as a means to induce benefits on patient balance. However, limits in efficacy and consistency still exist. In this study, the investigators will test the effects of TDCS+TUS combined with PT on postural instability of PD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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" PD, as defined by the current clinical criteria (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson's Disease. Arch Neurol.1999;56:33-39) as confirmed by co-investigator neurologist, or confirmation via medical records or a letter from patient physician;
- •Complaints about balance impairment or postural instability due to PD (self-report);
- •Age from 40 to 90 years old;
- •Taking stable medications for PD 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 or brain ablation surgeries, malignant mass brain lesions;
- •History of schizophrenia, bipolar illness; history of alcohol/drug abuse within the past 6 months;
- •Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
- •Contraindications to transcranial brain stimulation or TUS, i.e. metal in the head, implanted brain medical devices, etc.;
- •Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease);
- •Epilepsy or disorders that significantly increase likelihood of seizures including: severe traumatic brain injury, congenital birth defects leading to seizures, brain tumor, metabolic disorders associated with seizures, intracranial or subarachnoid hemorrhage, and nonlacunar strokes.
- •Recent (<= 2 months) or planned enrollment in an additional physician prescribed physical therapy program during their time in the trial.
- •Presence of another disorder that might have a significant impact on balance (as assessed by a co-investigator neurologist).
- •Bed or wheelchair-bound
研究组 & 干预措施
Active tDCS and Active TUS
Active tDCS and Active TUS for 20 min
干预措施: Active Comparator: Active tDCS and Active TUS (Device)
Active tDCS and Active TUS
Active tDCS and Active TUS for 20 min
干预措施: Physical Therapy (Other)
Sham TDCS and Sham TUS
Sham TDCS and Sham TUS for 20 min
干预措施: Sham Comparator: Sham TDCS and Sham TUS (Device)
Sham TDCS and Sham TUS
Sham TDCS and Sham TUS for 20 min
干预措施: Physical Therapy (Other)
结局指标
主要结局
Improvement in Unified Parkinson's Disease Rating Scale (UPDRS) Part III
时间窗: Change from baseline to Day 14 (end of stimulation treatment).
Motor function was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III - Motor Examination, which measures tremor, rigidity, bradykinesia, postural instability, and gait. Scores range from 0 to 108, where higher scores indicate worse motor impairment (i.e., lower scores represent better motor function).
次要结局
未报告次要终点
研究者
Felipe Fregni, MD, PhD, MPH
Director, Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital & Massachusetts General Hospital, Harvard Medical School
Spaulding Rehabilitation Hospital