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Enrolling by invitation Not applicable

Visuospatial and Affective Abilities in Parkinson Disease

NCT06341829 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-04-30
Last updated
2026-02-24

Condition(s) studied

Parkinson DiseaseAlexithymiaVisuospatial/Perceptual Abilities

Investigational drug(s) / intervention(s)

Prismatic adaptationSchirmer test

Prismatic 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.

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
Accepted
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: * \- 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).

Primary outcome measure(s)

  • Improve visuospatial skills; — 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; — 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; — 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

Trial sites (1)

FacilityCityRegionStatus
Laura Culicetto Messina Messina
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06341829 on ClinicalTrials.gov ↗ ← All trials in Italy