Clinical trial NCT03178786: Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease
Official title: Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Art Therapy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Eye Movement Analysis
timeFrame: 19 Weeks
measure: Rey-Osterrieth Complex Figure Test
timeFrame: 19 Weeks
measure: Benton test
timeFrame: 19 Weeks
measure: Corsi Block Test
timeFrame: 19 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Alberto Cucca, MD
role: PRINCIPAL_INVESTIGATOR
References: