NCT06281314

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

February 20, 2024

Last Update Submit

March 6, 2024

Conditions

Neurodegenerative DiseasesCognitive DeclineParkinson Disease DementiaAlzheimer DiseaseMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Parkinson'disease group

EXPERIMENTAL

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.

Device: Vespa software

Multiple Sclerosis group

EXPERIMENTAL

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.

Device: Vespa software

Alzheimer group

EXPERIMENTAL

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.

Device: Vespa software

Interventions

Vespa softwareDEVICE

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).

Alzheimer groupMultiple Sclerosis groupParkinson'disease group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with Alzheimer Disease, Multiple Sclerosis, Parkinson Disease
  • Severity of mild to moderate cognitive impairment
  • Sign informed consent

You may not qualify if:

  • Important comorbidities with psychiatric syndromes
  • Failure to sign the informed consent
  • Atypical parkinsonisms
  • Clinical conditions that involve vision-related problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Sicily, 98124, Italy

Location

MeSH Terms

Conditions

Neurodegenerative DiseasesCognitive DysfunctionAlzheimer DiseaseMultiple Sclerosis

Condition Hierarchy (Ancestors)

Nervous System DiseasesCognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Francesco Corallo, PSY

    IRCCS Centro Neurolesi Bonino Pulejo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2024

First Posted

February 28, 2024

Study Start

March 1, 2021

Primary Completion

December 27, 2022

Study Completion

December 31, 2023

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations

IT(1)