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Visuospatial and Affective Abilities in Parkinson Disease

Assessment and Rehabilitation of Visuospatial and Affective Abilities in Parkinson Disease

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06341829
Enrollment
126
Registered
2024-04-02
Start date
2024-04-30
Completion date
2026-02-28
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease, Alexithymia, Visuospatial/Perceptual Abilities

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.

Interventions

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.

Sponsors

IRCCS Centro Neurolesi Bonino Pulejo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Improve visuospatial skills;2 yearsBetter 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 yearsimprovement 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 yearsinvestigate 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

Secondary

MeasureTime frameDescription
Improve the quality of life with PDQ-39 questionnaire2 yearsPromote 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.
Non invasive biomarkerUntil the end of the studywe 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.

Countries

Italy

Contacts

PRINCIPAL_INVESTIGATORLaura Culicetto

IRCCS Centro Neurolesi Bonino Pulejo

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026