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 range56 Years – 75 Years

SexALL

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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

What they're measuring

Prospective Memory Test

Timeframe: From baseline to Post-Training (4 weeks)

Planning Tasks

Timeframe: From Baseline to Post-Training (4 weeks)

Shifting Task

Timeframe: From Baseline to Post-Training (4 weeks)

Updating task

Timeframe: From the baseline to Post-Training (4 weeks)

Trial details

NCT IDNCT06801782

SponsorI.R.C.C.S. Fondazione Santa Lucia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-03