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Clinical Trials/NCT06341829
NCT06341829
Enrolling By Invitation
Not Applicable

Assessment and Rehabilitation of Visuospatial and Affective Abilities in Parkinson Disease

IRCCS Centro Neurolesi Bonino Pulejo1 site in 1 country126 target enrollmentApril 30, 2024

Overview

Phase
Not Applicable
Intervention
Prismatic adaptation
Conditions
Parkinson Disease
Sponsor
IRCCS Centro Neurolesi Bonino Pulejo
Enrollment
126
Locations
1
Primary Endpoint
Improve visuospatial skills;
Status
Enrolling By Invitation
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 30, 2024
End Date
February 28, 2026
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Laura Culicetto

psychologist

IRCCS Centro Neurolesi Bonino Pulejo

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).

Arms & Interventions

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.

Intervention: Prismatic adaptation

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.

Intervention: Schirmer test

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.

Intervention: Prismatic adaptation

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.

Intervention: Schirmer test

Neutral prismatic adaptation, neutral virtual prismatic adaptation

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

Intervention: Prismatic adaptation

Neutral prismatic adaptation, neutral virtual prismatic adaptation

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

Intervention: Schirmer test

Outcomes

Primary Outcomes

Improve visuospatial skills;

Time Frame: 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;

Time Frame: 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;

Time Frame: 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

Secondary Outcomes

  • Improve the quality of life with PDQ-39 questionnaire(2 years)
  • Non invasive biomarker(Until the end of the study)

Study Sites (1)

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