Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease (ExplorArtPD)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Parkinson's Disease
|
PD subjects will be tested twice, that is, within four weeks before (Baseline) and after the completion of 9 PAT projects (Follow up).
|
|
Sham Comparator: Healthy Control Subjects
|
PD subjects will be tested twice, that is, within four weeks before (Baseline) and after the completion of 9 PAT projects (Follow up).
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eye Movement Analysis
Time Frame: 19 Weeks
|
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).
|
19 Weeks
|
|
Rey-Osterrieth Complex Figure Test
Time Frame: 19 Weeks
|
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)
|
19 Weeks
|
|
Benton test
Time Frame: 19 Weeks
|
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.
|
19 Weeks
|
|
Corsi Block Test
Time Frame: 19 Weeks
|
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.
|
19 Weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Alberto Cucca, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 17-00191
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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