Back to resultsStimulation of the Rostral Zona Incerta for Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Deep Brain Stimulation
Eligibility Criteria
Inclusion Criteria:
- Parkinson's Disease,
- No current deep brain stimulating electrodes
Exclusion Criteria:
- Other movement disorders,
- Parkinson's Disease with already implanted electrode.
Sites / Locations
- University of Colorado
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
STN Monopolar Stimulation
rZI + STN stimulation
Outcomes
Primary Outcome Measures
Motor testing
Blinded UPDRS testing
Secondary Outcome Measures
Dyskinesias
Unified Dyskinesia Rating Scale
Cognition
Montreal Cognitive Assessment
Depression
Hamilton Depression Rating Scale
Anxiety
Hamilton Anxiety Rating Scale
Suicide
Columbia Suicide Severity Ratting Scale
Non-motor features of Parkinson's disease
Movement Disorder Society-UPDRS I
Motor aspects of daily living
Movement Disorder Society-UPDRS II
Full Information
NCT ID
NCT03212885
First Posted
July 7, 2017
Last Updated
January 31, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT03212885
Brief Title
Stimulation of the Rostral Zona Incerta for Parkinson's Disease
Official Title
Deep Brain Stimulation (DBS) of the Rostral Zona Incerta (rZI) for Parkinson's Disease (PD): Clinical Efficacy and Evaluation of Adverse Effects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 3, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with Parkinson's Disease who undergo Deep Brain Stimulation surgery receive symptom relief due to electrical stimulation of the brain. The target for the stimulation, in many cases, is the subthalamic nucleus (STN). The brain area just above the STN is called the rostral Zona Incerta (rZI). The rZI may be a potential target for deep brain stimulation, in combination with the STN.
Detailed Description
Deep brain stimulation (DBS) of an area of the brain called the subthalamic nucleus (STN) is an effective treatment in Parkinson's disease (PD). However, stimulating the STN can lead to unwanted side effects that involve muscle movements (dyskinesias) and behavior and mood problems. DBS of a different brain structure, called the rostral zona incerta (rZI), has been demonstrated to be as effective as stimulating the STN, without any unwanted side effects in several studies. However, there is great variability in reported efficacy and adverse effects of rZI stimulation likely due to challenges in locating this area in the brain. The goals of this study are 1) to develop an improved method for targeting the rZI 2) determine efficacy of rZI with STN stimulation compared with STN stimulation alone, 3) evaluate any stimulation adverse effects of combined stimulation of the rZI and STN.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep Brain Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
STN Monopolar Stimulation
Arm Title
2
Arm Type
Experimental
Arm Description
rZI + STN stimulation
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Electrode that provides electrical stimulation to deep brain structures for relief of Parkinson's Disease symptoms.
Primary Outcome Measure Information:
Title
Motor testing
Description
Blinded UPDRS testing
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Dyskinesias
Description
Unified Dyskinesia Rating Scale
Time Frame
1 week
Title
Cognition
Description
Montreal Cognitive Assessment
Time Frame
1 week
Title
Depression
Description
Hamilton Depression Rating Scale
Time Frame
1 week
Title
Anxiety
Description
Hamilton Anxiety Rating Scale
Time Frame
1 week
Title
Suicide
Description
Columbia Suicide Severity Ratting Scale
Time Frame
1 week
Title
Non-motor features of Parkinson's disease
Description
Movement Disorder Society-UPDRS I
Time Frame
1 week
Title
Motor aspects of daily living
Description
Movement Disorder Society-UPDRS II
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson's Disease,
No current deep brain stimulating electrodes
Exclusion Criteria:
Other movement disorders,
Parkinson's Disease with already implanted electrode.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Drew S Kern, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stimulation of the Rostral Zona Incerta for Parkinson's Disease
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