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

NCT ID: NCT03178786

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-18
• Study Completion Date: 2020-08-10

Brief Summary

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Parkinson's Disease

Group Type: EXPERIMENTAL

PAT sessions

Intervention Type: BEHAVIORAL

PD subjects will be tested twice, that is, within four weeks before (Baseline) and after the completion of 9 PAT projects (Follow up).

Healthy Control Subjects

Group Type: SHAM_COMPARATOR

PAT sessions

Intervention Type: BEHAVIORAL

PD subjects will be tested twice, that is, within four weeks before (Baseline) and after the completion of 9 PAT projects (Follow up).

Interventions

PAT sessions

PD subjects will be tested twice, that is, within four weeks before (Baseline) and after the completion of 9 PAT projects (Follow up).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alberto Cucca, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

17-00191

Identifier Type: -

Identifier Source: org_study_id