Neurodegenerative DiseasesNCT06281314
The Efficacy of VESPA 2.0 for Cognitive Rehabilitation in Patients With Mild Cognitive Impairment
A study testing Vespa software in people with Neurodegenerative Diseases and Cognitive Decline, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Diseases, Cognitive Decline, Parkinson Disease Dementia
- What is being tested?
- Vespa software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Alzheimer Disease, Multiple Sclerosis, Parkinson Disease
- Severity of mild to moderate cognitive impairment
- Sign informed consent
Who cannot join
- Important comorbidities with psychiatric syndromes
- Failure to sign the informed consent
- Atypical parkinsonisms
- Clinical conditions that involve vision-related problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VESPA 2.0 - Virtual Environment for a Superior Neuropsychiatry Second Generation
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.
Read the 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.
- Conditions
- Neurodegenerative Diseases, Cognitive Decline, Parkinson Disease Dementia, Alzheimer Disease, Multiple Sclerosis
- Being tested
- Vespa software
- Medical subject headings
- Neurodegenerative Diseases, Cognitive Dysfunction, Alzheimer Disease, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Vespa software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2021
- Primary completion27 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Corallo, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Francesco Corallo, PSY, Principal investigator, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281314
- Sponsor's protocol ID
- VESPA 2.0
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VESPA 2.0 - Virtual Environment for a Superior Neuropsychiatry Second Generation
- ClinicalTrials.gov ID
- NCT06281314
- Acronym / sponsor ID
- VESPA 2.0
- Conditions
- Neurodegenerative Diseases, Cognitive Decline, Parkinson Disease Dementia, Alzheimer Disease, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 27 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson'disease group | Experimental | Device: Vespa softwareRehabilitation 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 | Experimental | Device: Vespa softwareRehabilitation 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 | Experimental | Device: Vespa softwareRehabilitation 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. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with Alzheimer Disease, Multiple Sclerosis, Parkinson Disease
- Severity of mild to moderate cognitive impairment
- Sign informed consent
Key exclusion criteria (4 listed)
- Important comorbidities with psychiatric syndromes
- Failure to sign the informed consent
- Atypical parkinsonisms
- Clinical conditions that involve vision-related problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vespa softwareThe 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). | Device | Alzheimer group, Multiple Sclerosis group, Parkinson'disease group |
Primary outcome
Montreal cognitive assessment (MoCA)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Corallo, PSY principal investigator
IRCCS Centro Neurolesi Bonino Pulejo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vespa software in people with Neurodegenerative Diseases and Cognitive Decline, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal cognitive assessment (MoCA) (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.