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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06281314
Other study ID # VESPA 2.0
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date December 31, 2023

Study information

Verified date March 2024
Source IRCCS Centro Neurolesi "Bonino-Pulejo"
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

VESPA 2.0 is based on an integrative and ecological approach used for the treatment of cognitive dysfunction in patients with MCI or other neurodegenerative disorders.


Description:

The goal of this study is to verify the effectiveness of the intensive-individual cognitive participation intervention (SCI-i) on the general cognitive functioning and specific cognitive functions of patients with mild or moderate cognitive decline affected by Alzheimer's dementia, Parkinson's and Multiple Sclerosis. Participants will be subjected to cognitive training (tasks on attention, memory, language, executive functions, and visual-spatial functions) through software. They will take place using virtual cameras and virtual reality (VR) viewers. All subjects will undergo follow-up evaluation.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 31, 2023
Est. primary completion date December 27, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 70 Years
Eligibility Inclusion Criteria: - Patients diagnosed with Alzheimer Disease, Multiple Sclerosis, Parkinson Disease - Severity of mild to moderate cognitive impairment - Sign informed consent Exclusion Criteria: - Important comorbidities with psychiatric syndromes - Failure to sign the informed consent - Atypical parkinsonisms - Clinical conditions that involve vision-related problems.

Study Design


Intervention

Device:
Vespa software
The Vespa2.0 project refers to the production of tasks useful for neuropsychological rehabilitation, aimed at subjects suffering from Alzheimer's Dementia, Parkinson's and Multiple Sclerosis. It is a neuropsychological rehabilitation project using Virtual Reality (VR).

Locations

Country Name City State
Italy IRCCS Centro Neurolesi Bonino Pulejo Messina Sicily

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Montreal cognitive assessment (MoCA) MoCA (Montreal Cognitive Assessment or The MoCA Test) was validated as a highly sensitive tool for early detection of mild cognitive impairment (MCI) It quickly and accurately assesses: Short term memory; Visuospatial abilities; Executive functions; Attention, concentration, and working memory; Language; Orientation to time and place
Results :
26-30 points: No cognitive impairment 18-25 points: Mild cognitive impairment. 10-17 points: Moderate cognitive impairment. Fewer than 10 points: Severe cognitive impairment.
up to 6 weeks
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