Status:
NOT_YET_RECRUITING
Cognitive Rehabilitation With Virtual Reality in Parkinson Disease
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
Università Campus Bio-Medico di Roma (UCBM)
Khymeia Group S.r.l.
Conditions:
Parkinson Desease
Mild Cognitive Impairment (MCI)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The OPERA Clinical Study is an interventional, single-arm, open-label pilot clinical study that aims to evaluate the usability of an innovative bio-cooperative robotic platform (PRoBio) for cognitive ...
Detailed Description
The pilot study will be conducted at two clinical centers, the Fondazione Don Carlo Gnocchi ONLUS sites in Sant'Angelo dei Lombardi (AV) and Florence (FI). The first step involves obtaining informed ...
Eligibility Criteria
Inclusion
- Diagnosis of mild Parkinson's Disease (Hoehn \& Yahr stage II-III);
- Diagnosis of Mild Cognitive Impairment (MCI) according to Litvan et al. (2012) criteria for PD-MCI;
- Age ≥ 18 years;
- Signed informed consent
Exclusion
- Diagnosis of Parkinson's Disease Dementia, atypical parkinsonisms, secondary parkinsonisms, or mixed forms;
- Severe depressive syndrome
- Absence of signed informed consent
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06920511
Start Date
May 1 2025
End Date
July 31 2025
Last Update
April 9 2025
Active Locations (1)
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1
Fondazione Don Gnocchi
Sant'Angelo dei Lombardi, Avellino, Italy, 83054