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

NCT03178786 | Completed

• 1 other identifier: 17-00191
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Art Therapy

Outcome Measures

Primary Outcomes (4)

• Eye Movement Analysis

  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

  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

  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

  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

Study Arms (2)

Parkinson's Disease

EXPERIMENTAL

Behavioral: PAT sessions

Healthy Control Subjects

SHAM COMPARATOR

Behavioral: PAT sessions

Interventions

PAT sessions BEHAVIORAL

PD subjects will be tested twice, that is, within four weeks before (Baseline) and after the completion of 9 PAT projects (Follow up).

Healthy Control Subjects; Parkinson's Disease

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of PD according to United Kingdom Parkinson's Disease Society Brain Bank;
• Hoehn and Yahr stage 2 to 3;

You may not qualify if:

• 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.
• 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.
• 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;

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Alberto Cucca, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: June 7, 2017
• Study Start: July 18, 2017
• Primary Completion: January 30, 2020
• Study Completion: August 10, 2020
• Last Updated: March 21, 2022

Record last verified: 2022-03

Locations

US (1)