Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 6 for:    art therapy | Parkinson Disease
Previous Study | Return to List | Next Study

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 : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: PAT sessions Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Parkinson's Disease 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).

Sham Comparator: Healthy Control Subjects 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).




Primary Outcome Measures :
  1. 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).

  2. 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)

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178786


Contacts
Layout table for location contacts
Contact: Daniella Mania 646 501 4363 daniella.mania@nyumc.org

Locations
Layout table for location information
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Daniella Mania    646-501-4367    daniella.mania@nyumc.org   
Principal Investigator: Milton Biagioni, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
Layout table for investigator information
Principal Investigator: Milton Biagioni, MD NYU Langone Health

Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03178786     History of Changes
Other Study ID Numbers: 17-00191
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NYU Langone Health:
Art Therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases