The Effect of Virtual Hand Movements on Functional Tremor - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Task performance
研究概览
简要总结
This study investigates the effect of virtual reality (VR) motor tasks on functional movement disorders.
详细描述
The investigators want to investigate how different display modes of virtual hands and the experimental manipulation of the visual representation of virtual hand movements affect (1) the performance of the hand movements (2) the tremor and (3) the subjective perception of the tremor.
There are three groups: Patients with functional tremor (FT), patients with essential tremor (ET) and healthy controls (HC). The study is carried out on one or two consecutive days. The first appointment is only made for patients with ET and FT and is used for the neurological examination and to assess the severity of the tremor. It takes place at the Outpatient Clinic for Movement Disorders at the University Clinic for Neurology in Graz and lasts a maximum of 30 minutes. The second appointment is at the Institute of Psychology at the University of Graz and requires the active participation of the respondent for 2.5 hours. Subjects are asked not to take any tremor-influencing medication on the day of the examination. HC will only attend the appointment at the Institute of Psychology.
First appointment:
- Clinical Global Impression - Severity Scale (CGI-S): 5-point Likert scale, clinicians assess the severity of the condition
- Patient Global Impression of Severity (PGI-S): 5-point Likert scale, patients assess the severity of the condition
- Fahn Tolosa Marin Tremor Rating Scale (FTM): assesses the tremor severity
- Simplified Version of the Functional Movement Disorders Rating Scale (S-FMDRS): assesses the severity of the functional tremor
Second appointment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •diagnosis of functional tremor (FT) or essential tremor (ET) or healthy control persons
- •In patients with FT and ET: presence of a constant or intermittent tremor during the neurological examination
排除标准
- •unclear tremor syndrome
- •essential tremor plus (ET plus)
- •conditions that interfere with EEG diagnostic (skin conditions, skin infections, wounds)
- •reflex epilepsy
- •cervical degeneration or chronic pain syndrome of the cervical spine
- •severe somatic illness
- •previous cerebral or head surgery
- •implanted pacemaker or deep brain stimulation
- •persons who are unable to consent
结局指标
主要结局
Task performance
时间窗: 4 measurement points: abstract hand model without time pressure, abstract hand model with time pressure, realistic hand model without time pressure, realistic hand model with time pressure. Approximately 2.5 hours
Reaction time in processing the VR task, measured in seconds
次要结局
- EEG(10 measurement points: resting state before each motor task and during each motor task; Approximately 2.5 hours)
- Tremor duration(5 measurement points: tasks a, b, c, d; Approximately 2.5 hours)
- Subjective tremor severity on a visual analogue scale (VAS)(6 measurement points: before and after each task; Approximately 2.5 hours)
- VR acceptance(2 measurement points: before and after the VR examination, Approximately 2.5 hours)