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VisMemoPD Protocol: an Observational Pilot Study on Spatial and Topographical Memory in Patients With Parkinson's Disease and Parkinsonism (VISMEMO-PD)

2026年9月14日 更新者:IRCCS San Raffaele Roma

VisMemoPD Protocol: An Observational Pilot Study on Spatial and Topographical Memory in Patients With Parkinson's Disease and Parkinsonism

VISMEMO-PD is an observational pilot study aimed at investigating visuospatial memory in reaching space and topographical memory in navigational space in patients with Parkinson's disease and Parkinsonism. The protocol is based on the hypothesis that topographical memory may deteriorate before visuospatial memory, suggesting that navigational memory impairment could represent an early indicator of disease progression. The study will include 80 participants stratified into four groups: patients with mild Parkinson's disease, patients with moderate-advanced Parkinson's disease, patients with Parkinsonism, and healthy participants. Visuospatial memory will be assessed using the Corsi Block-tapping Test, while topographical memory will be assessed using the Walking Corsi Test. Walking motor patterns will be recorded using wearable inertial sensors from the MOVIT system, and visual exploration strategies will be assessed using a wearable Pupil Labs eye-tracking system. The integration of cognitive, motor, and eye-tracking measures may support the identification of early neuropsychological markers and the development of tailored neurorehabilitation pathways for individuals with Parkinson's disease and Parkinsonism.

研究概览

详细说明

Parkinson's disease is a chronic neurodegenerative condition characterized by both motor and non-motor symptoms. Among non-motor manifestations, cognitive decline is common and heterogeneous and may occur already in the early stages of the disease. VISMEMO-PD was developed as part of a broader research framework aimed at identifying neuropsychological markers capable of predicting disease progression and the risk of conversion to Parkinson's disease dementia through targeted clinical protocols.

The present study focuses on the assessment of visuospatial memory in reaching space and topographical memory in navigational space. The theoretical rationale underlying the protocol is based on the hypothesis that the execution of sequences in navigational space may be impaired before the execution of sequences in reaching space. This would suggest that topographical memory impairment may represent an early marker of disease progression.

The study will compare performance across four groups: patients with mild Parkinson's disease, patients with moderate-advanced Parkinson's disease, patients with Parkinsonism, and healthy participants. The Corsi Block-tapping Test will be used to assess visuospatial memory in reaching space. The Walking Corsi Test, a walking adaptation of the Corsi Block-tapping Test, will be used to assess navigational memory in extrapersonal space. During the Walking Corsi Test, participants will reproduce spatial sequences by actively moving through the testing environment.

The protocol will also investigate the association between topographical memory deficits and walking motor patterns. Gait-related parameters will be recorded using wearable inertial sensors from the MOVIT system, consisting of a triaxial accelerometer, a magnetic sensor, and a triaxial gyroscope. These measures will allow the objective recording of movement-related parameters during task execution.

In addition, visual exploration strategies during visuospatial and topographical memory tasks will be assessed using a wearable Pupil Labs eye-tracking system. Eye-tracking data will be used to quantify gaze behavior, including fixation-related parameters, saccadic exploration, gaze transitions between relevant spatial targets, and visual scanning patterns. The integration of eye-tracking measures with cognitive performance and gait-related parameters is expected to provide a more comprehensive description of the visuocognitive and visuomotor mechanisms involved in spatial and topographical memory impairment in Parkinson's disease and Parkinsonism.

The study will include baseline assessment and follow-up evaluations at 12 and 24 months. Repeated assessments will allow the investigation of temporal trajectories of cognitive decline and may contribute to the development of predictive models capable of identifying patients at greater risk of conversion to dementia. The integration of longitudinal cognitive, motor, and visual exploration data may ultimately contribute to the definition of multidimensional biomarkers of disease progression.

研究类型

观察性的

注册 (估计的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Frosinone
      • Cassino、Frosinone、意大利、03043
        • IRCCS San Raffaele Cassino - CTC Via G. di Biasio, 1
    • Roma
      • Roma、Roma、意大利、00185
        • University of Roma La Sapienza Department of Psychology University of Rome 00185, Rome
      • Roma、Roma、意大利、00185
        • University of Roma La Sapienza Department of Psychology University of Rome
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Patients with Parkinson's disease, Parkinsonism, and healthy participants

描述

Inclusion Criteria

  • Male and female subjects aged between 35 and 80 years;
  • Diagnosis of Parkinson's disease according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank criteria;
  • Diagnosis of primary atypical parkinsonism MSA-P, according to the Second Consensus Statement on the Diagnosis of Multiple System Atrophy;
  • Diagnosis of primary atypical parkinsonism PSP-P, according to the Movement Disorder Society criteria for Progressive Supranuclear Palsy;
  • Modified Hoehn and Yahr stage between 1 and 3 during the "ON" phase (Hoehn and Yahr, 1967);
  • Cognitive screening with the Montreal Cognitive Assessment (MoCA) score > 17;
  • Mini-Mental State Examination (MMSE) score ≥ 24 (Folstein et al., 1975);
  • Ability to walk independently for 10 meters without assistive devices;
  • Ability to understand and sign the informed consent form;
  • Ability to comply with study procedures.

Exclusion Criteria

  • Diagnosis of neurological disorders other than Multiple System Atrophy (MSA) and Parkinson's disease;
  • Depressive disorders or Beck Depression Inventory-II (BDI-II) score > 20;
  • Musculoskeletal disorders that could impair gait performance.

The study will enroll 20 healthy subjects, matched by age and sex with patients affected by Parkinson's disease (PD) and atypical parkinsonism who will be recruited into the study.

The same inclusion criteria will be applied to both groups of patients with Multiple System Atrophy (MSA) and Parkinson's disease.

The exclusion criteria will be:

  • Diagnosis of neurological disorders;
  • Depressive disorders or Beck Depression Inventory-II (BDI-II) score > 20;
  • Musculoskeletal disorders that could impair gait performance.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Patients with mild Parkinson's disease
Participants will undergo visuospatial memory assessment using the Corsi Block-Tapping Test and topographical memory assessment using the Walking Corsi Test. Gait parameters will be recorded using wearable inertial sensors, while visual exploration strategies will be assessed using a wearable eye-tracking system. Assessments will be performed at baseline and repeated at 12 and 24 months.
Patients with moderate-advanced Parkinson's disease
Participants will undergo visuospatial memory assessment using the Corsi Block-Tapping Test and topographical memory assessment using the Walking Corsi Test. Gait parameters will be recorded using wearable inertial sensors, while visual exploration strategies will be assessed using a wearable eye-tracking system. Assessments will be performed at baseline and repeated at 12 and 24 months.
Patients with Parkinsonism
Participants will undergo visuospatial memory assessment using the Corsi Block-Tapping Test and topographical memory assessment using the Walking Corsi Test. Gait parameters will be recorded using wearable inertial sensors, while visual exploration strategies will be assessed using a wearable eye-tracking system. Assessments will be performed at baseline and repeated at 12 and 24 months.
Healthy participants
Participants will undergo visuospatial memory assessment using the Corsi Block-Tapping Test and topographical memory assessment using the Walking Corsi Test. Gait parameters will be recorded using wearable inertial sensors, while visual exploration strategies will be assessed using a wearable eye-tracking system. Assessments will be performed at baseline and repeated at 12 and 24 months.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Comparison between topographical memory in navigational space and visuospatial memory in reaching space
大体时间:Baseline, 12 months, and 24 months
Assessment and comparison of topographical memory performance in navigational space and visuospatial memory performance in reaching space. Topographical memory will be evaluated using the Walking Corsi Test, while visuospatial memory will be evaluated using the Corsi Block-tapping Test. The outcome will be used to identify navigational memory deficits and to investigate whether impairment in navigational space may anticipate impairment in reaching-space visuospatial memory.
Baseline, 12 months, and 24 months

次要结果测量

结果测量
措施说明
大体时间
Integrated assessment of topographical memory, gait patterns, and visual exploration strategies
大体时间:Baseline, 12 months, and 24 months
Evaluation of the relationships among topographical memory performance, walking motor patterns, and visual exploration strategies during the Corsi Block-tapping Test and Walking
Baseline, 12 months, and 24 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年10月1日

研究完成 (估计的)

2028年10月1日

研究注册日期

首次提交

2026年9月14日

首先提交符合 QC 标准的

2026年9月14日

首次发布 (实际的)

2026年9月18日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年9月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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