Convection Enhanced Delivery of CSF in DBS for Parkinson's
| Status: | Completed |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 3/30/2019 |
| Start Date: | February 13, 2018 |
| End Date: | December 18, 2018 |
Convection Enhanced Delivery of Autologous Cerebral Spinal Fluid Improves MRI Visualizations of Basal Ganglion Nuclei During Deep Brain Stimulation Surgery
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.
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.
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.
We found this trial at
1
site
Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: William J Elias, MD
Phone: 434-243-9986
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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