Clinical trial NCT06801782: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson&amp;#39;s Disease with Cognitive Impairment
Healthy Elderly
Keywords: placebo controlled trial
Cognitive training
Prospective Memory
Virtual reality
Telemedicine
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
Collaborators: name: University of Padova
First posted: 2025-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 56
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study examines the efficacy of attention and executive function training on prospective memory (PM) and executive functions in individuals with Parkinson's disease and mild cognitive impairment (PD-MCI), using a combined immersive virtual reality (iVR) and telemedicine approach. PM impairments, closely linked to deficits in episodic memory and executive functions, are a significant challenge in PD-MCI. Healthy volunteers are included as an additional group, undergoing the same intervention protocol, to evaluate baseline differences and the generalizability of the training effects.

Participants are randomly assigned to one of two arms: a training group (TR-C) or an active placebo group (AP-C). Both PD-MCI patients and healthy volunteers in the TR-C group engage in immersive virtual environments featuring real-life scenarios that require planning, task-switching, and updating skills, with tasks progressively increasing in complexity. The AP-C group completes simpler daily tasks with lower cognitive demands, serving as an active control condition. The intervention is conducted entirely remotely using telemedicine platforms and iVR headsets, ensuring accessibility and ecological validity. Assessments of PM and attention/executive functions are conducted at three time points: baseline (T0), post-training (T1, 4 weeks), and follow-up (T2, 2 months). The primary outcomes include improvements in PM performance and executive functions, as well as the retention of these training effects over time. By including healthy volunteers undergoing identical protocols, the study provides a robust comparison to evaluate both intervention-specific benefits and baseline cognitive differences between groups. This research aims to demonstrate the potential of iVR-based cognitive training to improve not only PM but also broader executive functions in both clinical and healthy populations, highlighting the applicability of innovative technologies in addressing cognitive challenges associated with neurodegenerative conditions and promoting cognitive health more broadly.

Eligibility criteria: 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

Primary outcomes:
measure: Prospective Memory Test
timeFrame: From baseline to Post-Training (4 weeks)
measure: Planning Tasks
timeFrame: From Baseline to Post-Training (4 weeks)
measure: Shifting Task
timeFrame: From Baseline to Post-Training (4 weeks)
measure: Updating task
timeFrame: From the baseline to Post-Training (4 weeks)
Secondary outcomes:
measure: Effects duration over time
timeFrame: From the end of the training to 2-month follow-up
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Santa Lucia Foundation
Study officials:
References: