Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation
Primary Purpose
Parkinson's Disease, Deep Brain Stimulation
Status
Enrolling by invitation
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's Disease
Eligibility Criteria
Inclusion Criteria:
- All patients will be enrolled from the practice of the primary investigator.
- Parkinson's Disease (PD) patients in whom optimal medical therapy has failed.
- All patients will have responsivity to levodopa.
- Individuals with normal or mild cognitive impairment.
Exclusion Criteria:
- Clinically significant dementia
- Other significant neurological or psychiatric disease
- Previous brain surgery including pallidotomy or thalamotomy
- Previous placement of other implantable devices
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Deep Brain Stimulation
Arm Description
Parkinson's disease patients who would otherwise be undergoing subthalamic nucleus (STN) deep brain stimulation (DBS) will have dual hemispheric stimulation of the STN and globus pallidus interna (GPi).
Outcomes
Primary Outcome Measures
Change in memory testing from presurgical baseline to 12 months
Memory will be assessed with the Hopkins Verbal Learning Test. The test consists of a set of six forms. Each test includes a list of 12 nouns; the examiner reads the list to the examinee, who repeats as many words as remembered, in any order. This process is repeated three times; 20-25 minutes later, examinees are asked again to recall as many words as possible; for the final task, the examiner reads a list of 24 words (including the 12 words from the list) and asks the examinee after each whether the word was on the list. For interpreting findings, in each metric listed (total recall, delayed recall, retention), higher scores reflect better learning efficiency (total recall) and memory (delayed recall, retention). Since this is a longitudinal study, follow-up scores will be compared to baseline. A positive direction of change would be interpreted as "improved" and a negative direction of change would be interpreted as "declined".
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01563341
Brief Title
Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation
Official Title
Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus potentially improve cognitive function in patients with Parkinsons disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Deep Brain Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Deep Brain Stimulation
Arm Type
Experimental
Arm Description
Parkinson's disease patients who would otherwise be undergoing subthalamic nucleus (STN) deep brain stimulation (DBS) will have dual hemispheric stimulation of the STN and globus pallidus interna (GPi).
Intervention Type
Device
Intervention Name(s)
Deep brain stimulation
Intervention Description
Study will be utilizing multiple brain electrodes simultaneously. The study will require at least two electrodes to be placed in one cerebral hemisphere (one for motor improvement and one for potential cognitive implications).
Primary Outcome Measure Information:
Title
Change in memory testing from presurgical baseline to 12 months
Description
Memory will be assessed with the Hopkins Verbal Learning Test. The test consists of a set of six forms. Each test includes a list of 12 nouns; the examiner reads the list to the examinee, who repeats as many words as remembered, in any order. This process is repeated three times; 20-25 minutes later, examinees are asked again to recall as many words as possible; for the final task, the examiner reads a list of 24 words (including the 12 words from the list) and asks the examinee after each whether the word was on the list. For interpreting findings, in each metric listed (total recall, delayed recall, retention), higher scores reflect better learning efficiency (total recall) and memory (delayed recall, retention). Since this is a longitudinal study, follow-up scores will be compared to baseline. A positive direction of change would be interpreted as "improved" and a negative direction of change would be interpreted as "declined".
Time Frame
baseline, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients will be enrolled from the practice of the primary investigator.
Parkinson's Disease (PD) patients in whom optimal medical therapy has failed.
All patients will have responsivity to levodopa.
Individuals with normal or mild cognitive impairment.
Exclusion Criteria:
Clinically significant dementia
Other significant neurological or psychiatric disease
Previous brain surgery including pallidotomy or thalamotomy
Previous placement of other implantable devices
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Uitti, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation
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