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Trial record 2 of 13 for:    parkinson's disease PARS

Using Parkinson's Disease to Study the Role of the Substantia Nigra Pars Reticulata

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by University of Colorado, Denver
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT02216435
First received: August 12, 2014
Last updated: June 2, 2016
Last verified: June 2016
  Purpose
Parkinson's Disease (PD) is a movement disorder causing either uncontrolled movement, slowness of movement, slowness of initiation of movement or rigidity of muscles. Deep Brain Stimulation (DBS) is the FDA-approved method for patients who no longer get effective treatment from the best available medication. The location in the brain where the electrode is placed during DBS surgery for PD is called the Subthalamic Nucleus or STN. This study aims to investigate another location in the brain, the Substantia nigra pars reticulata or SNr. The SNr is also known to be involved in motor control of muscles and may be involved in the process by which the initiation of movement occurs.

Condition
Parkinson's Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Using Parkinson's Disease to Study the Role of the Substantia Nigra Pars Reticulata in Movement Initiation and Perception

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Activity of the SNr [ Time Frame: Immediately ] [ Designated as safety issue: No ]
    Recording and evaluating brain activity from the SNr in Parkinson's disease patients while the patient is undergoing the visual motor testing during Deep Brain Stimulation Surgery.


Estimated Enrollment: 70
Study Start Date: July 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Detailed Description:
Parkinson's Disease (PD) is a movement disorder causing either uncontrolled movement, slowness of movement, slowness of initiation of movement or rigidity of muscles. One method of easing PD symptoms is the FDA-approved method of Deep Brain Stimulation (DBS) for patients who no longer get effective treatment from the best available medication. The location in the brain where the electrode is placed during DBS surgery for PD is called the Subthalamic Nucleus or STN. During placement of the DBS electrode, the patient is awake and is asked to do motor tasks to determine the correct placement in the STN and proper functioning of the DBS electrode. This study aims to investigate another location in the brain, the Substantia nigra pars reticulata or SNr, during the normal placement of the DBS electrode. This location is also known to be involved in motor control of muscles and may be involved in the process by which the initiation of movement occurs. The path through the brain to the STN used for DBS surgery goes into the SNr but currently, no testing of the SNr is performed. We will conduct a simple and well documented visual motor test to document the patient's stimulus perception and motor intention both at rest and during neural stimulation of the SNr.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Parkinson's disease who are candidates for Deep Brain Stimulation surgery.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's disease
  • must be able to undergo awake surgery DBS
  • must have unaided vision to view visual motor task

Exclusion Criteria:

  • corrective eyeglasses or contact lenses
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02216435

Contacts
Contact: Pamela David Gerecht, Ph.D. 303-724-4134 pamela.davidgerecht@ucdenver.edu

Locations
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Principal Investigator: Aviva Abosch, M.D., Ph.D.         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Aviva Abosch, M.D., Ph.D. University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02216435     History of Changes
Other Study ID Numbers: 13-2965  Univeristy of Colorado 
Study First Received: August 12, 2014
Last Updated: June 2, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 29, 2016