ClinicalTrials.gg
Enrolling by invitationNCT06341829Updated Nov 5, 2026

Visuospatial and Affective Abilities in Parkinson Disease

An interventional study of Prismatic adaptation and Schirmer test in Parkinson Disease, Alexithymia and Visuospatial/Perceptual Abilities, sponsored by IRCCS Centro Neurolesi Bonino Pulejo. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by IRCCS Centro Neurolesi Bonino Pulejo · Not applicable, Interventional, and Diagnostic

Updated Nov 5, 2026Study completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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. 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.

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Conditions studied

  • Parkinson Disease
  • Alexithymia
  • Visuospatial/Perceptual Abilities
03

In context

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 126 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

IRCCS Centro Neurolesi Bonino Pulejo is the lead sponsor of 67 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • - Sensory-motor deficits that can hinder neuropsychological assessment;
  • Visual system disorders (blindness, glaucoma);
  • Atypical parkinsonisms;
  • PD with dementia according to the criteria of the (DSM-IV) (American Psychiatric Association).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
126 participants (estimated)

Study arms

  • Experimental
    Right prismatic adaptation, right virtual primastic adaptation

    Participants will undergo either right prismatic adaptation or right virtual prism adaptation, along with cognitive and motor assessments.

    Other: Prismatic adaptation · Diagnostic Test: Schirmer test

  • Experimental
    Left prismatic adaptation, left virtual prismatic adaptation

    Participants will undergo either left prismatic adaptation or left virtual prism adaptation, along with cognitive and motor assessments.

    Other: Prismatic adaptation · Diagnostic Test: Schirmer test

  • Sham comparator
    Neutral prismatic adaptation, neutral virtual prismatic adaptation

    Participants will undergo neutral prism adaptation or neutral virtual prism adaptation, along with cognitive and motor assessments.

    Other: Prismatic adaptation · Diagnostic Test: Schirmer test

Interventions

  • OtherPrismatic adaptation

    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.

  • Diagnostic testSchirmer test

    Tear film will be collected from the right and left eyes.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 years

  2. 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

    Time frame: 2 years

  3. 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

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

  2. 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.

    Time frame: Until the end of the study

07

Study locations

1 site
  • Laura Culicetto
    Messina, Messina 98124, Italy
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Study completion
Feb 28, 2026→Feb 28, 2028
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Study completion Feb 28, 2026→Feb 28, 2028

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06341829
Lead sponsor
IRCCS Centro Neurolesi Bonino Pulejo
Responsible party
Laura Culicetto (psychologist, IRCCS Centro Neurolesi Bonino Pulejo) — Principal investigator
First posted
Apr 2, 2024
Start date
Apr 30, 2024
Primary completion
May 1, 2024
Completion
Feb 28, 2028 (estimated)
Last update
Nov 5, 2026

Study contacts

Laura Culicetto
principal investigator · IRCCS Centro Neurolesi Bonino Pulejo

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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