Visuospatial and Affective Abilities in Parkinson Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prismatic adaptation, Schirmer test.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Alexithymia, Visuospatial/Perceptual Abilities. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment and Rehabilitation of Visuospatial and Affective Abilities in Parkinson Disease
Overview
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
- Other 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. - Diagnostic test Schirmer test
Tear film will be collected from the right and left eyes.
Primary outcome measures
- Improve visuospatial skills; [Time frame: 2 years]
- Modulate alexithymia; [Time frame: 2 years]
- Investigation of brain activity; [Time frame: 2 years]
Secondary outcome measures (2)
- Improve the quality of life with PDQ-39 questionnaire [Time frame: 2 years]
- Non invasive biomarker [Time frame: Until the end of the study]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- Laura Culicetto — Messina
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. PMID 25341015
Identifiers
NCT: NCT06341829 · PRISM1