Pilot Study of the Ambulatory Monitoring Evaluation of a Mindfulness Meditation Programme in Parkinsonian Tremor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Essential Tremor Embarrassment Assessment score
研究概览
简要总结
Mindfulness meditation is an approach that has shown interest in treatment of anxiety in Parkinson's disease. This pilot study aims to assess a more specific effect on tremor using Essential Tremor Embarrassment Assessment and inertial sensors allowing monitoring during sessions and in daily life. This study will focus on 20 patients (10 with and without Mindfulness based intervention and will aim to develop the interface and demonstrate proof of concept before setting up a controlled study
详细描述
Methodology: Randomized, pilot study comparing 2 parallel arms (Mindfullness group versus group with routine care).
Number of patients:20
Patient selection: patients with severe rest tremor
Duration of project: 12 months
Schedule visit: 4 visits in 6 months
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
- None
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson disease
- •Hoehn st and yahr stage <or = 3
- •Age between 35 and 85 years old
- •Treatment stabilized for at least 3 months
- •Disturbing parkinsonian tremor of the upper limb (item MDS -UPDRS 2.10> 1) and lasting 2 to 6 hours per day
- •patients with internet access
排除标准
- •Presence of disturbing dyskinetic movements (Item MDS-UPDRS4.2> 1)
- •Patient who has already practiced meditation in the last 5 years
- •Untreated major depressive episode
- •Hallucinations (Item MDS-UPDRS1.2> 1))
- •Psychotic disorders - Confusional syndrome
- •presence of signs in favor of an atypical parkinsonian syndrome (oculomotor impairment, early falls, hallucinations, MoCA <20, early dysautonomia)
- •adult protected by law (guardianship, curatorship or under legal protection)
- •deprivation of liberty by judicial or administrative decision
- •high probability of non-compliance with the protocol or abandonment during the study
- •refusal to sign informed consent
- •Pregnant or breastfeeding woman
- •Lack of social coverage.
结局指标
主要结局
Essential Tremor Embarrassment Assessment score
时间窗: Month 6 (M6)
Essential Tremor Embarassment Assessment scale, ETEA : this scale is a self questionnaire made up of 14 items (0 to 5, 5 = worst embarrassment)
次要结局
- duration of tremor assessed by agenda(Day 0 (inclusion), Month 3 (M3))
- duration of tremor assessed by sensors monitoring(Day 0 (inclusion), Month 3 (M3))
- feasability of the study : number of patients enrolled(Month 6 (M6))
- feasability of the study : number of patients ended the study(Month 6 (M6))
- feasability of the study : hours of recording of the tremor(Month 6 (M6))
- feasability of the study : tolerance(Month 6 (M6))
- feasability of the study : COREQ 1(Month 6 (M6))
- Severity tremor index assessed by sensors monitoring(Month 3 (M3))
- Quality of life : Parkinson Disease Questionnaire 39 (PDQ39) scale(Month 6 (M6))
- Quality of life : Hamilton anxiety and depression scale (HADS)(Month 6 (M6))
- feasability of the study : COREQ 1(Month 6 (M6))
- Severity tremor index assessed by sensors monitoring(Month 3 (M3))
- duration of tremor assessed by agenda(Day 0 (inclusion), Month 3 (M3))
- duration of tremor assessed by sensors monitoring(Day 0 (inclusion), Month 3 (M3))
- feasability of the study : number of patients enrolled(Month 6 (M6))
- feasability of the study : number of patients ended the study(Month 6 (M6))
- feasability of the study : hours of recording of the tremor(Month 6 (M6))
- feasability of the study : tolerance(Month 6 (M6))
- Quality of life : Parkinson Disease Questionnaire 39 (PDQ39) scale(Month 6 (M6))
- Quality of life : Hamilton anxiety and depression scale (HADS)(Month 6 (M6))