Back to resultsConvection Enhanced Delivery of CSF in DBS for Parkinson's
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intracerebral Infusion of Autologous Cerebral Spinal Fluid
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring DBS
Eligibility Criteria
Inclusion Criteria:
- Men and women, age 30 years and older
- Subjects with advanced PD who are scheduled for MRI-guided DBS surgery under general anesthesia
- Subjects who are able and willing to give informed consent and able to attend clinic visits through 6 months
- The target nucleus, GPi or STN, is visible on MRI so that it can be targeted for the study infusion and then for MRI-guided DBS
Exclusion Criteria:
- DBS surgery planned in the awake condition with microelectrode recordings and clinical testing
- Spinal pathology not amenable to lumbar puncture
- Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
- Legal incapacity or limited legal capacity as determined by the neuropsychologist
- Are participating or have participated in another clinical trial in the last 30 days
- Any illness that in the investigator's opinion preclude participation in this study.
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intracerebral Infusion of Autologous CSF
Arm Description
All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events That Are Related to Treatment
Safety will be determined by an evaluation of the incidence and severity of infusion-related side effects and complications from the first treatment day visit through the 6-month post-treatment time point. All AEs will be reported and categorized by investigators as definitely, probably, possibly, unlikely, or unrelated to the CSF infusion, and/or Parkinson's disease progression. Safety will be assessed by incidence and severity of AEs, including changes in physical examinations and neurological examinations, and the number of discontinuations due to AEs.
Secondary Outcome Measures
% Change in Un-medicated UPDRS, Motor Subsection (Part III) From Baseline to 6 Months
The efficacy endpoint will be focused on determining the degree of change in motor symptoms as measured from the in-medicated UPDRS, motor subsection (Part III).
Vd/Vi Ratio
The ratio of the volume of distribution (Vd) immediately following the infusion (Vi) with intraoperative 1.5T MRI, T2-weighted sequences to the volume of the infusion (Vi) will be calculated. Each volume is measured in microliters (uL). The distribution of the infusion by convective properties in a deep brain human nucleus (GPi or STN) will be determined by calculating the Vd/Vi ratio.
Baseline Levodopa Medication Equivalents (Milligrams)
Change in Quality of Life Assessment With PDQ-39 Questionnaire
The PDQ-39 questionnaire includes 39 quality of life questions rated on a scale of 0-4. 0 indicating least frequent (never) and 4 indicating most frequent (always). The mean change in the sum of the PDQ-39 questionnaire is being reported with a overall score of 0 being the best quality of life and a maximum score of 156 being the worst possible quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03540134
Brief Title
Convection Enhanced Delivery of CSF in DBS for Parkinson's
Official Title
Convection Enhanced Delivery of Autologous Cerebral Spinal Fluid Improves MRI Visualizations of Basal Ganglion Nuclei During Deep Brain Stimulation Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
December 18, 2018 (Actual)
Study Completion Date
December 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeff Elias, MD
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
This study will evaluate safety foremost but also the distribution and initial effectiveness of infusion-enhanced, MRI-guided DBS for patients with medication-refractory, Parkinson's disease
Detailed Description
This is an open-label, single-arm, pilot study investigating the safety and feasibility of infusion-enhanced, MRI-guided DBS electrode placement. The investigators intend to enroll patients with Parkinson's disease and medically-refractory motor symptoms, who are already planned for MRI-guided DBS electrodes under general anesthesia. The hypothesis of the study is that a convective micro-infusion of autologous CSF will enhance the T2-weighted MRI visualization of the targeted nucleus during image-guided DBS surgery for Parkinson's disease. The investigators will record standard clinical measures of PD at baseline and 6 months following DBS surgery. The study will recruit patients at a rate of approximately one a month and will take less than two years to complete.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
DBS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intracerebral Infusion of Autologous CSF
Arm Type
Experimental
Arm Description
All subjects will receive the intracerebral infusion of autologous cerebral spinal fluid (CSF) during their deep brain stimulation (DBS) surgery. The DBS surgery will be performed on the targeted nucleus either bilaterally or unilaterally, as previously determined by a multidisciplinary team of neurology, neurosurgery, and neuropsychology. During unilateral DBS surgery, the targeted nucleus will be infused using convection enhanced delivery (CED). The nondominant side will be infused during a bilateral DBS procedure.
Intervention Type
Device
Intervention Name(s)
Intracerebral Infusion of Autologous Cerebral Spinal Fluid
Intervention Description
Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events That Are Related to Treatment
Description
Safety will be determined by an evaluation of the incidence and severity of infusion-related side effects and complications from the first treatment day visit through the 6-month post-treatment time point. All AEs will be reported and categorized by investigators as definitely, probably, possibly, unlikely, or unrelated to the CSF infusion, and/or Parkinson's disease progression. Safety will be assessed by incidence and severity of AEs, including changes in physical examinations and neurological examinations, and the number of discontinuations due to AEs.
Time Frame
6 months postoperatively
Secondary Outcome Measure Information:
Title
% Change in Un-medicated UPDRS, Motor Subsection (Part III) From Baseline to 6 Months
Description
The efficacy endpoint will be focused on determining the degree of change in motor symptoms as measured from the in-medicated UPDRS, motor subsection (Part III).
Time Frame
6 months postoperatively in comparison to baseline
Title
Vd/Vi Ratio
Description
The ratio of the volume of distribution (Vd) immediately following the infusion (Vi) with intraoperative 1.5T MRI, T2-weighted sequences to the volume of the infusion (Vi) will be calculated. Each volume is measured in microliters (uL). The distribution of the infusion by convective properties in a deep brain human nucleus (GPi or STN) will be determined by calculating the Vd/Vi ratio.
Time Frame
Day of Surgery
Title
Baseline Levodopa Medication Equivalents (Milligrams)
Time Frame
Baseline
Title
Change in Quality of Life Assessment With PDQ-39 Questionnaire
Description
The PDQ-39 questionnaire includes 39 quality of life questions rated on a scale of 0-4. 0 indicating least frequent (never) and 4 indicating most frequent (always). The mean change in the sum of the PDQ-39 questionnaire is being reported with a overall score of 0 being the best quality of life and a maximum score of 156 being the worst possible quality of life.
Time Frame
6 months postoperatively in comparison to baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women, age 30 years and older
Subjects with advanced PD who are scheduled for MRI-guided DBS surgery under general anesthesia
Subjects who are able and willing to give informed consent and able to attend clinic visits through 6 months
The target nucleus, GPi or STN, is visible on MRI so that it can be targeted for the study infusion and then for MRI-guided DBS
Exclusion Criteria:
DBS surgery planned in the awake condition with microelectrode recordings and clinical testing
Spinal pathology not amenable to lumbar puncture
Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
Legal incapacity or limited legal capacity as determined by the neuropsychologist
Are participating or have participated in another clinical trial in the last 30 days
Any illness that in the investigator's opinion preclude participation in this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William J Elias, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Convection Enhanced Delivery of CSF in DBS for Parkinson's
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