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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PAT sessions
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring Art Therapy

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Parkinson's Disease

Healthy Control Subjects

Arm Description

Outcomes

Primary Outcome Measures

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).
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)
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2017
Last Updated
March 7, 2022
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03178786
Brief Title
Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease
Acronym
ExplorArtPD
Official Title
Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
August 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Art Therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parkinson's Disease
Arm Type
Experimental
Arm Title
Healthy Control Subjects
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
PAT sessions
Intervention Description
PD subjects will be tested twice, that is, within four weeks before (Baseline) and after the completion of 9 PAT projects (Follow up).
Primary Outcome Measure Information:
Title
Eye Movement Analysis
Description
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
Title
Rey-Osterrieth Complex Figure Test
Description
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
Title
Benton test
Description
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
Title
Corsi Block Test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Cucca, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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