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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03178786
Recruitment Status : Recruiting
First Posted : June 7, 2017
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE June 5, 2017
First Posted Date  ICMJE June 7, 2017
Last Update Posted Date August 30, 2019
Actual Study Start Date  ICMJE July 18, 2017
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
  • 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).
  • 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)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease
Official Title  ICMJE Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Behavioral: 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).
Study Arms  ICMJE
  • Experimental: Parkinson's Disease
    Intervention: Behavioral: PAT sessions
  • Sham Comparator: Healthy Control Subjects
    Intervention: Behavioral: PAT sessions
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Daniella Mania 929 455 5150 daniella.mania@nyumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03178786
Other Study ID Numbers  ICMJE 17-00191
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alberto Cucca, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP