Visuospatial and Affective Abilities in Parkinson Disease

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease; Visuospatial/Perceptual Abilities; Alexithymia
• Interventions: Other: Prismatic adaptation

• Registration Number: NCT06341829
• Lead Sponsor: IRCCS Centro Neurolesi "Bonino-Pulejo"

Brief Summary

The aim of the study is to investigate whether prismatic adaptation (AP), 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-26
• Status Verified: 2024-04
• Study First Posted: 2024-04-02
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Study Start: 2024-04-17
• Primary Completion: 2024-04-18
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 63

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left prismatic adaptation	Prismatic adaptation	This group will undergo left prismatic adaptation
Right prismatic adaptation	Prismatic adaptation	This group will undergo right prismatic adaptation
Neutral prismatic adaptation	Prismatic adaptation	This group will undergo neutral lenses

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Improve the quality of life with PDQ-39 questionnaire	2 years	Promote 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.