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



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:40 - 75
Updated:10/27/2018
Start Date:July 18, 2017
End Date:April 2019
Contact:Daniella Mania
Email:daniella.mania@nyumc.org
Phone:646 501 4363

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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.


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.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Milton Biagioni, MD
Phone: 646-501-4367
New York University School of Medicine NYU School of Medicine has a proud history that...
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