Convection Enhanced Delivery of CSF in DBS for Parkinson's

Parkinson Disease Clinical Trial

Official title:

Convection Enhanced Delivery of Autologous Cerebral Spinal Fluid Improves MRI Visualizations of Basal Ganglion Nuclei During Deep Brain Stimulation Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03540134
• Other study ID #: IRB-HSR #20457
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: December 18, 2018

Study information

• Verified date: March 2021
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Intracerebral Infusion of Autologous Cerebral Spinal Fluid
Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Jeff Elias, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months postoperatively
Secondary	% 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).	6 months postoperatively in comparison to baseline
Secondary	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.	Day of Surgery
Secondary	Baseline Levodopa Medication Equivalents (Milligrams)		Baseline
Secondary	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.	6 months postoperatively in comparison to baseline