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临床试验/NCT05409508
NCT05409508撤回不适用

Psychological Management by Meditation of Full COnscience in Virtual REality of People With Amyotrophic Lateral Sclerosis: Effects on Cognition, Behavior, Quality of Life and Psychological Well-being

University Hospital, Angers0 个研究点目标入组 46 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
46
主要终点
To assess the benefits of psychological care with mindfulness meditation in virtual reality versus psychological management without mindfulness meditation in virtual reality in terms of evolution over time

研究概览

简要总结

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that results in progressive paralysis of the muscles involved in voluntary motor skills, speech, swallowing and breathing. It also causes non-motor symptoms including psychological, cognitive and behavioral difficulties that have a negative impact on patients' quality of life, well-being and long-term development. There is no curative therapy for ALS and drug treatments have little effect on non-motor symptoms. Interventions based on mindfulness meditation, defined as a state of consciousness that arises when one decides to focus attention in the present moment without judgment on the real experience, seem to be a promising tool for the reduction of non-motor symptoms in a number of progressive neurological conditions (Alzheimer's disease, multiple sclerosis, etc.), suggesting that mindfulness significantly helps in the management of these symptoms. Our project therefore aims to implement a mindfulness meditation program adapted to the management of non-motor symptoms in ALS based on virtual reality (VR).

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Majors to inclusion
  • Mother tongue: French
  • Patients for whom ALS of bulbar or spinal form defined according to El Escorial criteria is possible, probable or certain
  • Able to carry out the investigations and interventions provided for in the protocol
  • Signature of informed consent to participate in the study

排除标准

  • Participation in intervention research modifying management
  • History likely to disrupt cognition (constituted stroke, sequelae of traumatic brain injury, active epilepsy, learning disabilities, alcohol dependence syndrome, drug use, psychiatric disorders), severe cognitive impairment (MMSE <24)
  • People who meet the diagnostic criteria for Frontotemporal Dementia
  • Pregnant or lactating women
  • Persons deprived of their liberty by administrative or judicial decision
  • Persons undergoing psychiatric care under duress
  • Persons subject to a legal protection measure
  • Persons unable to express their consent
  • Persons not affiliated or not beneficiaries of a social security scheme

研究组 & 干预措施

Patients with mindfulness meditation care

Experimental

干预措施: mindfulness meditation care (Other)

Patients without mindfulness meditation care

Active Comparator

干预措施: no mindfulness meditation care (Other)

结局指标

主要结局

To assess the benefits of psychological care with mindfulness meditation in virtual reality versus psychological management without mindfulness meditation in virtual reality in terms of evolution over time

时间窗: at 3 months

from a quality of life scale : ALSSQOL-R : the lower the score, the more the person feels a sense of well-being

次要结局

未报告次要终点

研究者

发起方
University Hospital, Angers
申办方类型
Other Gov
责任方
Sponsor

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