Detection of Internal Tremors by Oscillometry in Parkinson's Patient : a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Difference in intensity of the peak power at 4-6 Hz
研究概览
简要总结
The goal of the present study is to objectively access the presence of an Internal Tremor in Parkinson's disease. Inertial sensors will be used to detect the presence of a rhythmic oscillation of 3-4 Hz. The study will be performed in both Parkinson's disease patients and healthy controls to ascertain the specificity of this type of tremor.
详细描述
The interest in finding prodromal symptoms in Parkinson's disease has been growing. Internal tremor, felt subjectively by the patients, have been reported in some studies as being present on the Prodromal phases of the disease. An objective identification of this tremor has never been made. In this study we propose to objectively access the presence of Internal Tremor in Parkinson's Disease patients using accelerometers. A control population of healthy subjects will also be evaluated to confirm the specificity of tremor for a PD population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(For the experimental group)
- •Patient with idiopathic parkinson's disease
- •Mini Mental State Evaluation score above or equal to 25
- •Hoehn and Yahr scale score of ≤3 in the OFF phase, with postural stability allowing the patient to stand unaided for 1 minute.
- •Able to walk unassisted
- •Willing to undergo accelerometry in the OFF state
- •(For the control group)
- •Healthy volunteer subjects matched for age (+/- 5 years) and sex
- •Mini Mental State Evaluation score above or equal to 25
排除标准
- •(For the experimental group)
- •Patients with an atypical parkinsonian syndrome
- •Patients unable to walk or stand for more than one minute in the off state
- •Parkinson's patients treated with deep brain stimulation, apomorphine pump, or duodopa intestinal infusion, and foslevodopa
- •Pregnant patients
- •Major osteoarticular problems
- •Neurological condition that may affect gait
- •(For the control group)
- •Participants with significant gait impairment (osteoarticular disorder)
- •Those with a neurological disease that, in the investigator's judgment, may interfere with the study's outcome measure
- •Participants with a clinical tremor that may interfere with the measurement of the primary outcome (e.g., essential tremor, thyroid disease, or tremors induced by medication)
- •Pregnant participants
研究组 & 干预措施
Parkinson's disease patients
Parkinson's disease patient in the off phase.
干预措施: Detection of objective internal tremors (Diagnostic Test)
Healthy participants
Healthy participants
干预措施: Detection of objective internal tremors (Diagnostic Test)
结局指标
主要结局
Difference in intensity of the peak power at 4-6 Hz
时间窗: Baseline
Difference in maximum signal power in the 4 to 6 Hz frequency band of the objective internal tremor, recorded from the head sensor, between the group of Parkinson's patients and a matched group of healthy volunteers.
次要结局
- Association between subjective internal tremors and frequency peak between 4 and 6 Hz(Baseline)
- Association between Objective Internal Tremor and Motor Symptom Severity in Parkinson's Disease as Assessed by the MDS-UPDRS(Baseline)
- Evaluation of Objective Internal Tremor Powers Detected by Different Sensors in Parkinson's Disease(Baseline)
- Evaluation of Acceptability of Motion Sensor Examination Using the Visual Analog Scale(Baseline)