VisMemoPD Protocol: An Observational Pilot Study on Spatial and Topographical Memory in Patients With Parkinson's Disease and Parkinsonism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Comparison between topographical memory in navigational space and visuospatial memory in reaching space
研究概览
简要总结
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.
详细描述
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.
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
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with mild Parkinson's disease
Patients with mild Parkinson's disease
干预措施: Multimodal visuospatial and topographical memory assessment (Other)
Patients with moderate-advanced Parkinson's disease
Patients with moderate-advanced Parkinson's disease
干预措施: Multimodal visuospatial and topographical memory assessment (Other)
Patients with Parkinsonism
Patients with Parkinsonism
干预措施: Multimodal visuospatial and topographical memory assessment (Other)
Healthy participants
Healthy participants
干预措施: Multimodal visuospatial and topographical memory assessment (Other)
结局指标
主要结局
Comparison between topographical memory in navigational space and visuospatial memory in reaching space
时间窗: 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.
次要结局
- Integrated assessment of topographical memory, gait patterns, and visual exploration strategies(Baseline, 12 months, and 24 months)