Visuospatial and Affective Abilities in Parkinson Disease

NCT06341829 | Enrolling By Invitation

• 1 other identifier: PRISM1
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Alexithymia; Visuospatial/Perceptual Abilities

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  2 years

Secondary Outcomes (2)

• Improve the quality of life with PDQ-39 questionnaire

  2 years

• Non invasive biomarker

  Until the end of the study

Study Arms (3)

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.

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.

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.

Other: Prismatic adaptation; Diagnostic Test: Schirmer test

Interventions

Prismatic adaptation OTHER

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.

Left prismatic adaptation, left virtual prismatic adaptation; Neutral prismatic adaptation, neutral virtual prismatic adaptation; Right prismatic adaptation, right virtual primastic adaptation

Schirmer test DIAGNOSTIC_TEST

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

Left prismatic adaptation, left virtual prismatic adaptation; Neutral prismatic adaptation, neutral virtual prismatic adaptation; Right prismatic adaptation, right virtual primastic adaptation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

Laura Culicetto

Messina, Messina, 98124, Italy

Location

Related Publications (1)

• 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.

  PMID: 25341015 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Affective Symptoms

Interventions

Wettability

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Hydrophobic and Hydrophilic Interactions; Chemical Phenomena; Surface Properties

Study Officials

• Laura Culicetto

  IRCCS Centro Neurolesi Bonino Pulejo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: psychologist

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: April 2, 2024
• Study Start: April 30, 2024
• Primary Completion: May 1, 2024
• Study Completion: February 28, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

IT (1)