Effectiveness of Attention/executivefunctions Training on Prospective Memory Abilities of Parkins… (NCT06801782) | Clinical Trial Compass
CompletedNot Applicable
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
Italy60 participantsStarted 2020-04-12
Plain-language summary
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.
Who can participate
Age range
56 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a combination of immersive virtual reality and telemedicine to train attention and executive functions in people with Parkinson's disease and mild cognitive impairment — do you think that kind of technology-based approach could be appropriate or accessible for me given my current situation?
2Since this trial has already been completed, would you be able to help me find out what the results showed about whether the training actually improved prospective memory and planning abilities in people with Parkinson's-related cognitive impairment?
3The trial measured very specific cognitive skills like prospective memory, planning, shifting, and updating — how do those areas relate to the cognitive challenges I'm currently experiencing, and would targeting them make sense for my care?
4Because this was a non-drug, behavioral intervention study with a placebo-controlled design, what does that mean for how confident we can be in the safety and usefulness of this type of cognitive training compared to other options you might recommend?
5Are there similar completed or ongoing trials, or existing clinical programs, that use virtual reality or remote cognitive training for Parkinson's disease with mild cognitive impairment that might be worth exploring based on what this study found?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prospective Memory Test
Timeframe: From baseline to Post-Training (4 weeks)
2
Planning Tasks
Timeframe: From Baseline to Post-Training (4 weeks)
3
Shifting Task
Timeframe: From Baseline to Post-Training (4 weeks)
4
Updating task
Timeframe: From the baseline to Post-Training (4 weeks)