Parkinson's Disease with Cognitive ImpairmentNCT06801782
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
A study testing Experimental Cognitive training in Immersive Virtual Reality and Telemedicine approach and Active Comparator #1 in people with Parkinson's Disease with Cognitive Impairment and Healthy Elderly, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 56 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease with Cognitive Impairment, Healthy Elderly
- What is being tested?
- Experimental Cognitive training in Immersive Virtual Reality and Telemedicine approach and Active Comparator #1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2020to 17 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 56 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Experimental Cognitive training in Immersive Virtual Reality and Telemedicine approach, Active Comparator #1
- Keywords
- placebo controlled trial, Cognitive training, Prospective Memory, Virtual reality, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Cognitive training in Immersive Virtual Reality and Telemedicine approachBehavioural
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
Active Comparator #1Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Behavioral: Active Comparator #1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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
Measured: 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.
Measured: From the baseline to Post-Training (4 weeks)
Secondary outcomes (1)
Effects duration over time
Prospective Memory test (MIST) at 2-months follow up, (T2)
Measured: From the end of the training to 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start12 Apr 2020
- Primary completion3 Feb 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease with Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Padova
- Responsible party
- Principal investigator, Silvia Zabberoni, I.R.C.C.S. Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801782
- Sponsor's protocol ID
- CE/PROG.758
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Publications
Zabberoni S, De Simone MS, Taglieri S, Tieri G, Cona G, Fiorenzato E, Peppe A, Massimi V, Zannino GD, Carlesimo GA, Antonini A, Caltagirone C, Costa A. The effectiveness of i-virtual reality and telemedicine based cognitive approach for rehabilitation of prospective memory in individuals with Parkinson's disease and mild cognitive impairment: A randomized-controlled trial. Rehabil Psychol. 2026 Aug;71(3):417-430. doi: 10.1037/rep0000645. Epub 2026 Feb 16.
PubMed 41701233
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06801782
- Acronym / sponsor ID
- CE/PROG.758
- Keywords
- placebo controlled trial, Cognitive training, Prospective Memory, Virtual reality, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Collaborators
- University of Padova
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 3 Feb 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive executive functions training implemented in immersive virtual reality, remotly delivered | Experimental | Behavioral: Experimental Cognitive training in Immersive Virtual Reality and Telemedicine approachThe 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. |
| Active Placebo implemented in immersive virtual reality, remotly delivered | Active comparator | Behavioral: Active Comparator #1The 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). |
Who may qualify
- Ages
- 56 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental Cognitive training in Immersive Virtual Reality and Telemedicine approachThe 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 | Behavioural | Cognitive executive functions training implemented in immersive virtual reality, remotly delivered |
| Active Comparator #1The 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. | Behavioural | Active Placebo implemented in immersive virtual reality, remotly delivered |
Primary outcome
Prospective Memory Test
Time frame: From baseline to Post-Training (4 weeks)
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).
Planning Tasks
Time frame: From Baseline to Post-Training (4 weeks)
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
Shifting Task
Time frame: From Baseline to Post-Training (4 weeks)
The assessment of shifting abilities were tested using the Trail Making Test and the Alternate Fluency Task
Updating task
Time frame: From the baseline to Post-Training (4 weeks)
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.
1 secondary outcome
Effects duration over time
Time frame: From the end of the training to 2-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Derived from this study: PubMed 41701233Zabberoni S, De Simone MS, Taglieri S, Tieri G, Cona G, Fiorenzato E, Peppe A, Massimi V, Zannino GD, Carlesimo GA, Antonini A, Caltagirone C, Costa A. The effectiveness of i-virtual reality and telemedicine based cognitive approach for rehabilitation of prospective memory in individuals with Parkinson's disease and mild cognitive impairment: A randomized-controlled trial. Rehabil Psychol. 2026 Aug;71(3):417-430. doi: 10.1037/rep0000645. Epub 2026 Feb 16.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
Related trials for Parkinson's Disease with Cognitive Impairment
RecruitingPhase 2
Prevent Cognitive Decline in GBA-associated Parkinson's Disease
Parkinson's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Cognitive training in Immersive Virtual Reality and Telemedicine approach and Active Comparator #1 in people with Parkinson's Disease with Cognitive Impairment and Healthy Elderly, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospective Memory Test (time frame: From baseline to Post-Training (4 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06801782, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.