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

Not Applicable

Completed

• Conditions: Neurodegenerative Diseases; Cognitive Decline; Alzheimer Disease; Multiple Sclerosis; Parkinson Disease Dementia
• Interventions: Device: Vespa software

• Registration Number: NCT06281314
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-12-27
• Study Completion: 2023-12-31
• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parkinson'disease group	Vespa software	Rehabilitation takes place with individual one-hour sessions per day. The stimulation intervention is organized on 4 different themes (chosen from orientation, memory, praxis, language, executive functions, attention, problem-solving, and functional activities) for 15' each.
Multiple Sclerosis group	Vespa software	Rehabilitation takes place with individual one-hour sessions per day. The stimulation intervention is organized on 4 different themes (chosen from orientation, memory, praxis, language, executive functions, attention, problem-solving, and functional activities) for 15' each.
Alzheimer group	Vespa software	Rehabilitation takes place with individual one-hour sessions per day. The stimulation intervention is organized on 4 different themes (chosen from orientation, memory, praxis, language, executive functions, attention, problem-solving, and functional activities) for 15' each.

Primary Outcome Measures

Name	Time	Method
Montreal cognitive assessment (MoCA)	up to 6 weeks	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.

Trial Locations

Locations (1)

IRCCS Centro Neurolesi Bonino Pulejo; 🇮🇹 Messina, Sicily, Italy