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临床试验/NCT06690125
NCT06690125已完成不适用

Attention, Awareness, and Multisensory Integration in Patients with Unilateral Spatial Neglect Following Stroke

Universita di Verona1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2018年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Multisensory Computerized Test

研究概览

简要总结

The primary aim of this study is to investigate whether multisensory integration (MSI) mechanisms observed in patients with right hemisphere lesions without neglect remain intact compared to patients with Unilateral Spatial Neglect (USN).

This study also allows for a direct comparison between results from paper-based tests and computerized tests, as well as between patients with right hemisphere lesions without neglect and USN patients. The secondary objectives are:

To compare these results in order to obtain a more refined definition of USN at both the unisensory level (as computerized tests are rarely used in hospital settings but have proven effective in diagnosing USN) and the multisensory level (since USN is not generally tested in the auditory modality).

To measure eye movements in all patients in the study, as this can provide useful information for characterizing patient deficits.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients will be included in the study if they have:
  • Right hemisphere stroke
  • Presence of USN assessed through the Apple Cancellation
  • Age between 18 and 85 years
  • Signed informed consent
  • Both male and female participants
  • As a control group, patients will also be included if they have:
  • Right hemisphere stroke
  • Absence of USN assessed through the Apple Cancellation
  • Age between 18 and 85 years
  • Signed informed consent
  • Both male and female participants.

排除标准

  • Both patients with USN and control patients will be excluded if they:
  • Are minors
  • Are unable to give their consent to participate in the study
  • Have significant language deficits (production and comprehension) (e.g., unable to give a verbal response or understand instructions)
  • Have hemianopia
  • Have severe hearing impairments that cannot be corrected (e.g., with hearing aids)
  • Have severe uncorrected visual impairments (e.g., glaucoma)
  • Have a history of psychiatric disorders or substance abuse.

结局指标

主要结局

Multisensory Computerized Test

时间窗: Is conducted over a total of three different days, during which the patient will complete Task 3 in three separate sessions, one for each day.

In Task 3, the presentation occurs simultaneously, with 360 items distributed across 12 blocks of 30 items each, repeated over three days. In this case as well, the patient must localize the sources of light and sound. This integrated approach allows for a thorough evaluation of sensory localization abilities and analyzes the interaction between visual and auditory stimuli in the patient.

次要结局

  • Mini Mental State Examination (MMSE)(During the assessment required for the neuropsychological evaluation of the patient, conducted as per standard clinical practice upon admission to the ward.)
  • Apple Cancellation Test(The assessment is conducted within a week of admission to the ward.)
  • Line Bisection Test(The assessment is conducted within a week of admission to the ward.)
  • Catherine Bergego Scale (CBS)(The assessment is conducted within a week of admission to the ward.)
  • Visual neglect test(The assessment is conducted within a week of admission to the ward.)
  • Tactile neglect test(The assessment is conducted within a week of admission to the ward.)

研究者

发起方
Universita di Verona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Valentina Varalta

Doctor

Universita di Verona

研究点 (1)

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