NCT06801782Completed
Effectiveness of Attention/executivefunctions Training on Prospective Memory Abilities of Parkinson's Disease Subjects with Mild Cognitive Impairment and Healthy Aged Individuals: a Placebo-controlled Study with a Combined Immersive Virtual Reality and Telemedicine Approach
Source: ClinicalTrials.gov · Last updated 30 Jan 2025
Brief summary (registry, in English)
The goal of this randomized controlled trial is to evaluate the efficacy of attention and executive function training on prospective memory (PM) and executive functions in patients with Parkinson's disease and mild cognitive impairment (PD-MCI) and compare their performance to healthy volunteers. The study aims to determine whether immersive virtual reality (iVR) training can improve PM and executive function performance in PD-MCI patients, whether the effects of training are maintained over time, and how the PM and executive function performance of PD-MCI patients compares to that of healthy volunteers. Participants in the training group engage in real-life scenario exercises focused on planning, shifting, and updating tasks, while those in the placebo group perform simpler daily tasks with lower cognitive demands. Healthy volunteers serve as an additional control group. All sessions are conducted remotely using telemedicine and iVR headsets over a 4-week period. Outcome measures, including PM and executive function performance, are assessed at baseline, post-training, and a 2-month follow-up to evaluate the intervention's effectiveness and compare results across groups.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 17 Jan 2025
- Start date
- 12 Apr 2020
- Primary completion date
- 3 Feb 2024
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Diseases
- Parkinson disease
- NCT number
- NCT06801782
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 12 Apr 2020 to the primary completion date, 3 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- PD-MCI: i) Cognitive decline inconsistent with mild cognitive impairment; ii) no idiopathic Parkinson's disease; iii) presence of of important non neurological disease;
- Healthy volunteers: i) neuropsychological assessment characterized by a cognitive domain with a deficit or a score equivalent to 1 or 2, based on normative data; ii) presence of psychiatric or neurological disease
Who the study is looking for
- PD-MCI: i) idiopathic PD, according with the United Kingdom Parkinson's disease Society brain bank criteria; ii) diagnosis of MCI from neuropsychological screening battery and MMSE; specifically, were included in the study PD-MCI whose performance was 1.5 standard deviations below the normative sample at least on two tests, one of which assessed executive functions; iii) absence of pronounced dyskinesia; iv) absence of other psychiatric and neurological disorders than PD; v) absence of other serious non-neurological disorders; vi) no treatment with deep brain stimulation. All patients had been stably treated with L-dopa and/or dopamine agonists for at least three months prior to the administration of the neuropsychological screening and outcome measures and throughout the duration of the entire experimental protocol.
- Healthy Volunteers: i) no neurologic or psychiatric illness; ii) no other disese than neurological; iii) no alchool abuse; iv) neuropsychological screening with rates between 3-4 equivalent score based on normative population
Age in the registry: 56 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Santa Lucia Foundation Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.