VisMemoPD Protocol: an Observational Pilot Study on Spatial and Topographical Memory in Patients With Parkinson's Disease and Parkinsonism (VISMEMO-PD)
VisMemoPD Protocol: An Observational Pilot Study on Spatial and Topographical Memory in Patients With Parkinson's Disease and Parkinsonism
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Maria Gaglione
- E-mail: maria.gaglione@sanraffaele.it
Studie Contact Back-up
- Naam: Maria Francesca De Pandis, MD. PhD, Neurologist
- Telefoonnummer: 00390776394740
- E-mail: maria.depandis@sanraffaele.it
Studie Locaties
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Frosinone
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Cassino, Frosinone, Italië, 03043
- IRCCS San Raffaele Cassino - CTC Via G. di Biasio, 1
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Roma
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Roma, Roma, Italië, 00185
- University of Roma La Sapienza Department of Psychology University of Rome 00185, Rome
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Roma, Roma, Italië, 00185
- University of Roma La Sapienza Department of Psychology University of Rome
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Contact:
- Laura Piccardi
- E-mail: laura.piccardi@uniroma1.it
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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Patients with mild Parkinson's disease
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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.
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Patients with moderate-advanced Parkinson's disease
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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.
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Patients with Parkinsonism
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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.
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Healthy participants
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Comparison between topographical memory in navigational space and visuospatial memory in reaching space
Tijdsspanne: Baseline, 12 months, and 24 months
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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.
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Baseline, 12 months, and 24 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Integrated assessment of topographical memory, gait patterns, and visual exploration strategies
Tijdsspanne: Baseline, 12 months, and 24 months
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Evaluation of the relationships among topographical memory performance, walking motor patterns, and visual exploration strategies during the Corsi Block-tapping Test and Walking
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Baseline, 12 months, and 24 months
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Medewerkers en onderzoekers
Sponsor
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Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Synucleïnopathieën
- Neurologische manifestaties
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Psychische aandoening
- Neurocognitieve stoornissen
- Oogziekten
- Cognitieve stoornissen
- Tauopathieën
- Neurodegeneratieve ziekten
- Bewegingsstoornissen
- Basale ganglia-ziekten
- Ziekten van de hersenzenuw
- Primaire dysautonomieën
- Ziekten van het autonome zenuwstelsel
- Oftalmoplegie
- Oculaire Motiliteitsstoornissen
- Verlamming
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Cognitieve disfunctie
- Ziekte van Parkinson
- Meervoudige systeematrofie
- Supranucleaire verlamming, progressief
- Parkinson-stoornissen
Andere studie-ID-nummers
- VISMEMO-PD
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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