Parkinson DiseaseNCT06341829
Visuospatial and Affective Abilities in Parkinson Disease
A study testing Prismatic adaptation and Schirmer test in people with Parkinson Disease and Alexithymia, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
The aim of the study is to investigate whether prismatic adaptation (PA) and virtual prismatic adaptation (VPA), a non-invasive neuromodulation technique, that involves the use of lenses that deviate the visual field, can modulate alexithyima and performance in visuospatial tasks in patients with Parkinson disease. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Alexithymia, Visuospatial/Perceptual Abilities
- What is being tested?
- Prismatic adaptation and Schirmer test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old;
- Right-handed;
- Diagnosis of idiopathic Parkinson's disease according to the UK Brain Bank criteria (Lyon and Pahwa, 2011);
- Hoehn and Yahr Stadium (Hoehn and Yahr, 1996) <2,5;
- Stable pharmacological treatment (dopaminergic therapy: dopamine agonists and Levo-dopa) in the last 6 weeks.
Who cannot join
- - Sensory-motor deficits that can hinder neuropsychological assessment;
- Visual system disorders (blindness, glaucoma);
- Atypical parkinsonisms;
- PD with dementia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment and Rehabilitation of Visuospatial and Affective Abilities in Parkinson Disease
The aim of the study is to investigate whether prismatic adaptation (PA) and virtual prismatic adaptation (VPA), a non-invasive neuromodulation technique, that involves the use of lenses that deviate the visual field, can modulate alexithyima and performance in visuospatial tasks in patients with Parkinson disease. Furthermore, brain activity during the prismatic adaptation and post-adaptation phases will be recorded using functional near-infrared spectroscopy (fNIRS) and high-density electroencephalography (HD-EEG). Based on these premises, the present project aims to investigate the deficits of the affective, motor and visuospatial abilities in Parkinson's patients and the modulation of disorders through prismatic adaptation (PA) and virtual prism adaptation (VPA). Finally, we would like to evaluate production of the tear film and correlate their quantity with the severity of PD as it could be proposed as a new, non-invasive biomarker.
- Being tested
- Prismatic adaptation, Schirmer test
- Medical subject headings
- Parkinson Disease, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prismatic adaptationOther
Participants will fit with prismatic goggles that deviate their visual field by 13° either leftward or rightward. They will seat in front of a white horizontal board on which three target dots (5 mm diameter) were positioned at 0, -10 and +10° from their body midline at a distance of 57 cm from their eyes. They will perform a total of 150 verbally instructed pointing movements with their right index finger towards the right (+10°) and left (-10°) targets in a pseudorandom order.
Schirmer testDiagnostic test
Tear film will be collected from the right and left eyes.
| Study group | Role | What they receive |
|---|---|---|
| Right prismatic adaptation, right virtual primastic adaptation | Experimental | Participants will undergo either right prismatic adaptation or right virtual prism adaptation, along with cognitive and motor assessments. Receives: Other: Prismatic adaptation; Diagnostic Test: Schirmer test |
| Left prismatic adaptation, left virtual prismatic adaptation | Experimental | Participants will undergo either left prismatic adaptation or left virtual prism adaptation, along with cognitive and motor assessments. Receives: Other: Prismatic adaptation; Diagnostic Test: Schirmer test |
| Neutral prismatic adaptation, neutral virtual prismatic adaptation | Sham comparator | Participants will undergo neutral prism adaptation or neutral virtual prism adaptation, along with cognitive and motor assessments. Receives: Other: Prismatic adaptation; Diagnostic Test: Schirmer test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve visuospatial skills;
Better performance in tests that evaluate visuospatial skills like line bisection test. The minimun value is 0 and the maximum is 3. Higher scores mean a worse outcome
Measured: 2 years
Modulate alexithymia;
improvement in tests evaluating alexithymia such as TAS-20. The TAS 20 has scores that have a minimum of 20 and a maximum of 100. Scores greater than or equal to 61indicate high levels of alexithymia
Measured: 2 years
Investigation of brain activity;
investigate the brain areas involved in the tasks with High Density Electroencephalography (EEG HD) and functional near infrared spectroscopy (fNIRS). The most active areas will be listed in a table
Measured: 2 years
Secondary outcomes (2)
Improve the quality of life with PDQ-39 questionnaire
Promote rewarding experiences that improve self-esteem, the perceived sense of self-efficacy, the quality of life measured with the Parkinson's disease questionnaire (PDQ-39).The minimum score is 0 which indicates the best quality of life A maximum score is 100 which indicates the worst quality of life.
Measured: 2 years
Non invasive biomarker
we would like to evaluate production of the tear film and correlate their quantity with the severity of PD as it could be proposed as a new, non-invasive biomarker.
Measured: Until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start30 Apr 2024
- Primary completion1 May 2024
- Study completion28 Feb 2026 (estimated)
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 DiseaseStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Culicetto, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Laura Culicetto, Principal investigator, IRCCS Centro Neurolesi Bonino Pulejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341829
- Sponsor's protocol ID
- PRISM1
- Status last verified
- Feb 2026
- First submitted
- 8 Mar 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Karadi K, Lucza T, Aschermann Z, Komoly S, Deli G, Bosnyak E, Acs P, Horvath R, Janszky J, Kovacs N. Visuospatial impairment in Parkinson's disease: the role of laterality. Laterality. 2015;20(1):112-27. doi: 10.1080/1357650X.2014.936444. Epub 2014 Jul 10.
PubMed 25341015
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Rehabilitation of Visuospatial and Affective Abilities in Parkinson Disease
- ClinicalTrials.gov ID
- NCT06341829
- Acronym / sponsor ID
- PRISM1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 2 Apr 2024 (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 aim of the study is to investigate whether prismatic adaptation (PA) and virtual prismatic adaptation (VPA), a non-invasive neuromodulation technique, that involves the use of lenses that deviate the visual field, can modulate alexithyima and performance in visuospatial tasks in patients with Parkinson disease. Furthermore, brain activity during the prismatic adaptation and post-adaptation phases will be recorded using functional near-infrared spectroscopy (fNIRS) and high-density electroencephalography (HD-EEG). Based on these premises, the present project aims to investigate the deficits of the affective, motor and visuospatial abilities in Parkinson's patients and the modulation of disorders through prismatic adaptation (PA) and virtual prism adaptation (VPA). Finally, we would like to evaluate production of the tear film and correlate their quantity with the severity of PD as it could be proposed as a new, non-invasive biomarker.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Right prismatic adaptation, right virtual primastic adaptation | Experimental | Other: Prismatic adaptation, Diagnostic Test: Schirmer testParticipants will undergo either right prismatic adaptation or right virtual prism adaptation, along with cognitive and motor assessments. |
| Left prismatic adaptation, left virtual prismatic adaptation | Experimental | Other: Prismatic adaptation, Diagnostic Test: Schirmer testParticipants will undergo either left prismatic adaptation or left virtual prism adaptation, along with cognitive and motor assessments. |
| Neutral prismatic adaptation, neutral virtual prismatic adaptation | Sham comparator | Other: Prismatic adaptation, Diagnostic Test: Schirmer testParticipants will undergo neutral prism adaptation or neutral virtual prism adaptation, along with cognitive and motor assessments. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over 18 years old;
- Right-handed;
- Diagnosis of idiopathic Parkinson's disease according to the UK Brain Bank criteria (Lyon and Pahwa, 2011);
- Hoehn and Yahr Stadium (Hoehn and Yahr, 1996) <2,5;
- Stable pharmacological treatment (dopaminergic therapy: dopamine agonists and Levo-dopa) in the last 6 weeks.
Key exclusion criteria (4 listed)
- - Sensory-motor deficits that can hinder neuropsychological assessment;
- Visual system disorders (blindness, glaucoma);
- Atypical parkinsonisms;
- PD with dementia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association).
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 |
|---|---|---|
| Prismatic adaptationParticipants will fit with prismatic goggles that deviate their visual field by 13° either leftward or rightward. They will seat in front of a white horizontal board on which three target dots (5 mm diameter) were positioned at 0, -10 and +10° from their body midline at a distance of 57 cm from their eyes. They will perform a total of 150 verbally instructed pointing movements with their right index finger towards the right (+10°) and left (-10°) targets in a pseudorandom order. | Other | Left prismatic adaptation, left virtual prismatic adaptation, Neutral prismatic adaptation, neutral virtual prismatic adaptation, Right prismatic adaptation, right virtual primastic adaptation |
| Schirmer testTear film will be collected from the right and left eyes. | Diagnostic test | Left prismatic adaptation, left virtual prismatic adaptation, Neutral prismatic adaptation, neutral virtual prismatic adaptation, Right prismatic adaptation, right virtual primastic adaptation |
Primary outcome
Improve visuospatial skills;
Time frame: 2 years
Better performance in tests that evaluate visuospatial skills like line bisection test. The minimun value is 0 and the maximum is 3. Higher scores mean a worse outcome
Modulate alexithymia;
Time frame: 2 years
improvement in tests evaluating alexithymia such as TAS-20. The TAS 20 has scores that have a minimum of 20 and a maximum of 100. Scores greater than or equal to 61indicate high levels of alexithymia
Investigation of brain activity;
Time frame: 2 years
investigate the brain areas involved in the tasks with High Density Electroencephalography (EEG HD) and functional near infrared spectroscopy (fNIRS). The most active areas will be listed in a table
2 secondary outcomes
Improve the quality of life with PDQ-39 questionnaire
Time frame: 2 years
Non invasive biomarker
Time frame: Until the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 25341015Karadi K, Lucza T, Aschermann Z, Komoly S, Deli G, Bosnyak E, Acs P, Horvath R, Janszky J, Kovacs N. Visuospatial impairment in Parkinson's disease: the role of laterality. Laterality. 2015;20(1):112-27. doi: 10.1080/1357650X.2014.936444. Epub 2014 Jul 10.
- Individual participant dataSharing planned: Undecided
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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.
Laura Culicetto principal investigator
IRCCS Centro Neurolesi Bonino Pulejo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prismatic adaptation and Schirmer test in people with Parkinson Disease and Alexithymia, run by IRCCS Centro Neurolesi Bonino Pulejo 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 5 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 24 Feb 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Improve visuospatial skills; (time frame: 2 years). The study lists 3 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 NCT06341829, 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 24 Feb 2026.