- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02216435
Using Parkinson's Disease to Study the Role of the Substantia Nigra Pars Reticulata
January 31, 2023 updated by: University of Colorado, Denver
Using Parkinson's Disease to Study the Role of the Substantia Nigra Pars Reticulata in Movement Initiation and Perception
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Anschutz Medical Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with Parkinson's disease who are candidates for Deep Brain Stimulation surgery.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Activity of the SNr
Time Frame: Immediately during Deep Brain Stimulation Surgery
|
Recording and evaluating brain activity from the SNr (Substantia Nigra Pars Reticulata) in Parkinson's disease patients while the patient is undergoing the visual motor testing during Deep Brain Stimulation Surgery.
|
Immediately during Deep Brain Stimulation Surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John A Thompson, Ph.D., University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
February 22, 2021
Study Completion (Actual)
February 22, 2021
Study Registration Dates
First Submitted
August 12, 2014
First Submitted That Met QC Criteria
August 13, 2014
First Posted (Estimate)
August 15, 2014
Study Record Updates
Last Update Posted (Actual)
February 2, 2023
Last Update Submitted That Met QC Criteria
January 31, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-2965
- Univeristy of Colorado (Other Grant/Funding Number: 230 0894)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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