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临床试验/NCT04978857
NCT04978857招募中不适用

Feasibility Study of Virtual Reality to Promote the Awakening of Patients in a State of Minimal Consciousness

University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2022年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
8
试验地点
1
主要终点
percentage of patients without any adverse event or sign of bad tolerance

研究概览

简要总结

Advances in neurosurgery and neuroresuscitation have improved patients' prognosis. However, 2% of serious head injuries progress to a vegetative state, this condition persisting at 1 year for 1% of these patients.

The minimum state of consciousness is to be distinguished from coma and vegetative state, it is a condition marked by a severe alteration of consciousness in which there are minimal and fluctuating, but obvious, signs of environmental consciousness. There is a minimum degree of response to some stimulations, response generally fluctuating over time. In practice, these patients are unable to consistently follow simple instructions, but they often have a preserved visual pursuit (proper rotation of the head when someone enters the room, prolonged eye follow-up, etc.). Patients with minimal awareness have been shown to perceive emotions and pain. These patients may exhibit behavioural and emotional changes (smiling, crying motivated), induced by verbal stimulations (familiar voice). But these events remain fluctuating during the day or according to the days and interlocutors.

For the moment, the most commonly accepted strategy since the 1990s remains sensory stimulation (SS), while knowing that this term includes extremely varied stimulations (sensory, olfactory, auditory, fixation on a mirror, etc.) without the practice of this technique being well defined and systematized.

It has been shown that a regular family visit program with auditory, emotional and tactile stimuli improves the state of consciousness of these patients. Physicians also know that this SS must be personalized and adapted to the patient's tolerance and premorbid preferences.

SS programmes are poorly standardized. Programmes generally consist of a simple, moderate to high intensity, non-standardized stimulation, presented repetitively and frequently. Indeed, it has been shown that stimulation must begin early, be frequent, and continue until reactions appear.

In this project, investigator want to use the new technologies now commonly used such as photos, videos or sounds taken by smartphone's relatives of the brain patient-injured in order to make a personalized 3D film using film editing software and a predefined film frame, by integrating autobiographical elements and emotional, multisensory (binaural sound, vibration) integrating, if possible, a certain interactivity (haptic feedback, triggering of videos by the patient's eyes).

The objective is to develop an innovative multi-sensory stimulation technique through a personalised enriched environment to induce, facilitate and accelerate the return to consciousness of patients in altered state of consciousness during their initial management.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • Patient diagnosed with minimal consciousness
  • Patient affiliated or beneficiary of a social security scheme
  • Signature of consent by a relative of the patient
  • Tolerance of the multisensory stimulation material during the pre-inclusion phase

排除标准

  • Pregnant woman
  • Patient with contraindication to study procedures (Contraindication to wearing a virtual reality headset (unbalanced epilepsy, craniofacial trauma, major visual disturbances; contraindication to the fMRI)
  • Person deprived of liberty by judicial or administrative decision
  • Person receiving psychiatric care under duress

结局指标

主要结局

percentage of patients without any adverse event or sign of bad tolerance

时间窗: 1 month

to assess the feasibility of multisensory virtual reality stimulation proposed in this study in patients with minimal post-traumatic consciousness

次要结局

  • Patient clinical responses (blood pressure, body motion, eye-tracking)(1 month)
  • patient's relative satisfaction scale(1 month)
  • Time required for film design(2 weeks)
  • type and quantity of autobiographical material to be obtained from the patient's relatives(2 weeks)
  • Coma Recovery Scale - Revised (CRS-R)(6 month)
  • functional MRI(1 month)
  • Wessex Head Injury Matrix (WHIM)(6 month)
  • healthcare team satisfaction scale(1 month)

研究者

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

研究点 (1)

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