Visuospatial and Affective Abilities in Parkinson Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-17

Study Completion Date

2026-02-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Parkinson Disease Alexithymia Visuospatial/Perceptual Abilities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Right prismatic adaptation

This group will undergo right prismatic adaptation

Group Type EXPERIMENTAL

Prismatic adaptation

Intervention Type OTHER

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.

Left prismatic adaptation

This group will undergo left prismatic adaptation

Group Type EXPERIMENTAL

Prismatic adaptation

Intervention Type OTHER

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.

Neutral prismatic adaptation

This group will undergo neutral lenses

Group Type SHAM_COMPARATOR

Prismatic adaptation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes