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CompletedNCT03178786ExplorArtPDUpdated Mar 21, 2022

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

An interventional study of PAT sessions in Parkinson Disease, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-21.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Non-randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • Art Therapy
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 72 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Parkinson's Disease

    Behavioral: PAT sessions

  • Sham comparator
    Healthy Control Subjects

    Behavioral: PAT sessions

Interventions

  • BehavioralPAT sessions

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

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What researchers measure

Primary outcomes

  1. Eye Movement Analysis

    Eye positions will be recorded for both eyes concurrently. The system will record binocularly with a sampling frequency of 250Hz and a spatial accuracy of 0.5 degrees, approximately. Eye movement data will be analyzed off-line using customized MATLAB software (www.mathworks.com).

    Time frame: 19 Weeks

  2. Rey-Osterrieth Complex Figure Test

    These tests explore different aspects of visuospatial abilities including attention, memory, abstraction, planning and visuoexecutive skills; neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by copying it freehand (recognition), and then drawing from memory (recall)

    Time frame: 19 Weeks

  3. Benton test

    These tests explore different aspects of visuospatial abilities including attention, memory, abstraction, planning and visuoexecutive skills; individually administered test for people aged from eight years to adulthood that measures visual perception and visual memory. It can also be used to help identify possible learning disabilities among other afflictions that might affect an individual's memory. The individual examined is shown 10 designs, one at a time, and asked to reproduce each one as exactly as possible on plain paper from memory.

    Time frame: 19 Weeks

  4. Corsi Block Test

    These tests explore different aspects of visuospatial abilities including attention, memory, abstraction, planning and visuoexecutive skills; psychological test that assesses visuo-spatial short term working memory. It involves mimicking a researcher as he/she taps a sequence of up to nine identical spatially separated blocks.

    Time frame: 19 Weeks

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Study locations

1 site
  • New York University School of Medicine
    New York, New York 10016, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03178786
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Jun 7, 2017
Start date
Jul 18, 2017
Primary completion
Jan 30, 2020
Completion
Aug 10, 2020
Last update
Mar 21, 2022

Study contacts

Alberto Cucca, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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