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NCT07827963
VisMemoPD Protocol: an Observational Pilot Study on Spatial and Topographical Memory in Patients With Parkinson's Disease and Parkinsonism
Conditions: Parkinson's Disease, Parkinsonism, Multiple System Atrophy, Progressive Supranuclear Palsy, Mild Cognitive Impairment
Sex: All
Ages: 35 Years – 80 Years
Healthy volunteers: Yes
Enrollment: 80
Sponsor: IRCCS San Raffaele Roma
Location: IRCCS San Raffaele Cassino - CTC Via G. di Biasio, 1 Cassino Frosinone
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07827963). StuddyBuddy aggregates publicly available trial information.