The Efficacy of VESPA 2.0 for Cognitive Rehabilitation in Patients With Mild Cognitive Impairment

Multiple Sclerosis Clinical Trial

Official title:

VESPA 2.0 - Virtual Environment for a Superior Neuropsychiatry Second Generation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06281314
• Other study ID #: VESPA 2.0
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Decline
• Cognitive Dysfunction
• Multiple Sclerosis
• Neurodegenerative Diseases
• Parkinson Disease
• Parkinson Disease Dementia

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