Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease (ExplorArtPD)

NYU Langone Health

Status: Completed

Conditions: Parkinson Disease

Treatments: Behavioral: PAT sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT03178786

17-00191

Details and patient eligibility

About

The purpose of this dual phase cross-sectional, controlled and prospective, open label, exploratory study is to determine the general characteristics of visuospatial exploration and its neural substrate in subjects with Parkinson's Disease (PD) and to explore the impact of professional art therapy intervention in a cohort of subjects with Parkinson's Disease on visuospatial exploration, visuomotor integration, neuropsychological and emotional sphere, quality of daily living and motor symptoms.

Enrollment: 72 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Inclusion Criteria (Patients with PD)

• Diagnosis of PD according to United Kingdom Parkinson's Disease Society Brain Bank;
• Hoehn and Yahr stage 2 to 3;

Exclusion criteria

Exclusion Clinical Criteria (For both PD and Controls):

• History of dementia, or MoCA < 22;
• Untreated depression, or score of >20 on Beck Depression Inventory II;
• History of florid visual, tactile, olfactory or acoustic hallucinations requiring the administration of neuroleptics.
• Presence of psychosis requiring the administration of neuroleptics or sedatives.
• Presence of severe motor fluctuations with most of the 50% of day spent in off-time.
• Presence of bothersome dyskinesias.
• Presence of severe dystonia involving the head-neck axis including anterocollis, laterocollis and torticollis.
• Presence of severe fluctuations in attention, alertness or cognition.
• Presence of any clinically significant abnormality on vital signs.

Exclusion Ophthalmologic and Ophtalmometric Criteria (For both PD and Controls):

• Visual abnormalities requiring exclusive correction with eye glasses (of note, contact lenses are NOT an exclusion criterion).
• History of clinically active ophthalmologic abnormalities including but not limited to macular degeneration, symptomatic cataract, symptomatic retinopathy, recent orbital trauma with periorbital ecchymosis, symptomatic thyroid eye disease, refractory problems of moderate or severe degree (of note, mild refractory problems are NOT an exclusion criterion, chromatic discrimination problems including daltonism are NOT an exclusion criterion).
• History of any clinically significant CNS abnormality resulting in an active visual field deficit including but not limited to brain tumors, brain abscess, inflammatory encephalic lesions, traumatic brain injury or stroke.
• Clinically significant abnormal findings on routine bedside examination of the vision system during a standard clinical neurological exam.

Exclusion MRI Criteria (For both PD and Controls):

• Major or unstable medical illness;
• Left hand dominance;
• Pacemakers, neurostimulators, intracranial clips, metal implants, external clips or metal foreign bodies within 10 cm of the head;
• Current pregnancy or nursing;
• Pregnancy planned;
• Claustrophobia;
• Large body habitus (280 lb or more)

Exclusion Criteria for Art Therapy (For PD subjects only):

• Severe inability to perform line drawing;
• Severe inability to manipulate soft/light materials like clay.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Parkinson's Disease

Experimental group

Treatment:

Behavioral: PAT sessions

Healthy Control Subjects

Sham Comparator group

Treatment:

Behavioral: PAT sessions