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

NCT06801782 | Completed

• 1 other identifier: CE/PROG.758
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease with Cognitive Impairment; Healthy Elderly

Keywords

placebo controlled trial; Cognitive training; Prospective Memory; Virtual reality; Telemedicine

Outcome Measures

Primary Outcomes (4)

• Prospective Memory Test

  Prospective memory was assessed using the Memory for Intentions Screening Test, a task designed to evaluate prospective memory through eight trials: four time-based and four event-based. Each trial reflects real-life scenarios, and participants perform an ongoing word search task simultaneously. Scores for prospective memory range from 0 (failure) to 2 (correct execution). The test includes a multiple-choice recognition task, scored from 0 to 1, with a total score ranging from 0 to 8. A 24-hour delayed task assesses the ability to recall and execute a planned action after a day, such as calling the examiner at a specific time and reporting sleep hours, with scores from 0 (failure) to 2 (successful execution).

  From baseline to Post-Training (4 weeks)

• Planning Tasks

  All patients were administered neuropsychological tests at T0, T1 and T2.The assessment of planning skills were tested using the Zoo Map Test and Tower of London

  From Baseline to Post-Training (4 weeks)

• Shifting Task

  The assessment of shifting abilities were tested using the Trail Making Test and the Alternate Fluency Task

  From Baseline to Post-Training (4 weeks)

• Updating task

  All patients were administered neuropsychological tests at T0, T1 and T2.The assessment of updating was tested using the updating task belonging to the Zimmermann's Test of Every Day Attention.

  From the baseline to Post-Training (4 weeks)

Secondary Outcomes (1)

• Effects duration over time

  From the end of the training to 2-month follow-up

Study Arms (2)

Cognitive executive functions training implemented in immersive virtual reality, remotly delivered

EXPERIMENTAL

The training group (TR-C) underwent a 4-week immersive virtual reality (iVR) program designed to improve planning, shifting, and updating skills to enhance prospective memory (PM) in PD-MCI patients. Participants completed 12 sessions of 30 minutes each in a virtual supermarket, performing tasks that strengthened executive functions. The planning task involved planning a route to purchase items, the shifting task required alternating between product categories, and the updating task was based on a memory recall of objects. Each task had 10 levels, progressively increasing in difficulty, with participants advancing after completing three consecutive successful trials, receiving feedback at each level.

Behavioral: Experimental Cognitive training in Immersive Virtual Reality and Telemedicine approach

Active Placebo implemented in immersive virtual reality, remotly delivered

ACTIVE COMPARATOR

The active placebo group shared the same virtual environment and interaction methods as the training group (Arm 1), using the Oculus Go and remote telemedicine. This condition involved tasks with low cognitive demands, similar to everyday activities. The placebo-planning task required following a fixed shopping list order, the placebo-shifting task involved quickly selecting items from the shelves, and the placebo-updating task required remembering the last item from a conveyor belt sequence. The frequency, duration, and number of levels and trials were identical to the training condition (3 sessions per week, 30 minutes each, totaling 12 sessions over 4 weeks).

Behavioral: Active Comparator #1

Interventions

Experimental Cognitive training in Immersive Virtual Reality and Telemedicine approach BEHAVIORAL

The cognitive training involved a 4-week immersive virtual reality program to improve planning, cognitive flexibility, and information updating in patients with mild cognitive impairment related to Parkinson's disease. Over 12 sessions of 30 minutes each, participants trained in a virtual supermarket to strengthen attentional and executive skills. The planning task required creating and following a route to collect items while following rules, with increasing complexity. The cognitive flexibility task involved alternating between selecting items from different categories, with difficulty rising due to more categories and distractors. The updating task, set at a virtual checkout, challenged participants to memorize and recall items on a conveyor belt, with difficulty increasing based on sequence length and item count. Progression to higher levels required three successful trials, with feedback provided to support performance improvement

Cognitive executive functions training implemented in immersive virtual reality, remotly delivered

Active Comparator #1 BEHAVIORAL

The active placebo used the same virtual environment, Oculus Go system, and telemedicine setup as the training group, but engaged in tasks with low cognitive demands, mimicking everyday activities. The placebo-planning task involved following a fixed shopping list order in a modified version of the Zoo Map Test. The placebo-shifting task required selecting items from shelves without alternating between categories, while the placebo-updating task involved recalling only the last item from a conveyor belt sequence. The sessions mirrored the training group's structure, with 12 sessions over 4 weeks (3 per week, 30 minutes each), maintaining the same frequency, duration, and levels than Training.

Active Placebo implemented in immersive virtual reality, remotly delivered

Eligibility Criteria

• Age: 56 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead
• University of Padova: collaborator

Study Sites (1)

Santa Lucia Foundation

Rome, Italy, 00179, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher Psychologist, PhD, Princial Investigator

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 30, 2025
• Study Start: April 12, 2020
• Primary Completion: February 3, 2024
• Study Completion: July 17, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)