Visuospatial and Affective Abilities in Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

Assessment and Rehabilitation of Visuospatial and Affective Abilities in Parkinson Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06341829
• Other study ID #: PRISM1
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 17, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: April 2024
• Source: IRCCS Centro Neurolesi "Bonino-Pulejo"
• Contact: Laura Culicetto
• Phone: 090 60128417
• Email: laura.culicetto[@]irccsme.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: February 28, 2026
• Est. primary completion date: April 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Affective Symptoms
• Alexithymia
• Parkinson Disease
• Visuospatial/Perceptual Abilities

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Centro Neurolesi "Bonino-Pulejo"

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Improve the quality of life with PDQ-39 questionnaire	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.	2 years