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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Maria Gaglione
- E-Mail: maria.gaglione@sanraffaele.it
Studieren Sie die Kontaktsicherung
- Name: Maria Francesca De Pandis, MD. PhD, Neurologist
- Telefonnummer: 00390776394740
- E-Mail: maria.depandis@sanraffaele.it
Studienorte
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Frosinone
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Cassino, Frosinone, Italien, 03043
- IRCCS San Raffaele Cassino - CTC Via G. di Biasio, 1
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Roma
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Roma, Roma, Italien, 00185
- University of Roma La Sapienza Department of Psychology University of Rome 00185, Rome
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Roma, Roma, Italien, 00185
- University of Roma La Sapienza Department of Psychology University of Rome
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Kontakt:
- Laura Piccardi
- E-Mail: laura.piccardi@uniroma1.it
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Comparison between topographical memory in navigational space and visuospatial memory in reaching space
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Integrated assessment of topographical memory, gait patterns, and visual exploration strategies
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Synucleinopathien
- Neurologische Manifestationen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Psychische Störungen
- Neurokognitive Störungen
- Augenkrankheiten
- Kognitionsstörungen
- Tauopathien
- Neurodegenerative Krankheiten
- Bewegungsstörungen
- Erkrankungen der Basalganglien
- Erkrankungen der Hirnnerven
- Primäre Dysautonomien
- Erkrankungen des autonomen Nervensystems
- Ophthalmoplegie
- Augenmotilitätsstörungen
- Lähmung
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Kognitive Dysfunktion
- Parkinson Krankheit
- Multiple Systematrophie
- Supranukleäre Lähmung, progressiv
- Parkinsonsche Störungen
Andere Studien-ID-Nummern
- VISMEMO-PD
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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