Clinical trial NCT03540134: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: DBS
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 4
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Men and women, age 30 years and older
2. Subjects with advanced PD who are scheduled for MRI-guided DBS surgery under general anesthesia
3. Subjects who are able and willing to give informed consent and able to attend clinic visits through 6 months
4. 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:

1. DBS surgery planned in the awake condition with microelectrode recordings and clinical testing
2. Spinal pathology not amenable to lumbar puncture
3. Subjects who have had deep brain stimulation or a prior stereotactic ablation of the basal ganglia
4. Legal incapacity or limited legal capacity as determined by the neuropsychologist
5. Are participating or have participated in another clinical trial in the last 30 days
6. Any illness that in the investigator's opinion preclude participation in this study.

Primary outcomes:
measure: Number of Participants With Adverse Events That Are Related to Treatment
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: % Change in Un-medicated UPDRS, Motor Subsection (Part III) From Baseline to 6 Months
timeFrame: 6 months postoperatively in comparison to baseline
measure: Vd/Vi Ratio
timeFrame: Day of Surgery
measure: Baseline Levodopa Medication Equivalents (Milligrams)
timeFrame: Baseline
measure: Change in Quality of Life Assessment With PDQ-39 Questionnaire
timeFrame: 6 months postoperatively in comparison to baseline
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: William J Elias, MD
role: PRINCIPAL_INVESTIGATOR
References: