Convection Enhanced Delivery of CSF in DBS for Parkinson's

NCT03540134 | Completed Results FDA Device

• 1 other identifier: IRB-HSR #20457
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Keywords

DBS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• % Change in Un-medicated UPDRS, Motor Subsection (Part III) From Baseline to 6 Months

  6 months postoperatively in comparison to baseline

• Vd/Vi Ratio

  Day of Surgery

• Baseline Levodopa Medication Equivalents (Milligrams)

  Baseline

• Change in Quality of Life Assessment With PDQ-39 Questionnaire

  6 months postoperatively in comparison to baseline

Study Arms (1)

Intracerebral Infusion of Autologous CSF

EXPERIMENTAL

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.

Device: Intracerebral Infusion of Autologous Cerebral Spinal Fluid

Interventions

Intracerebral Infusion of Autologous Cerebral Spinal Fluid DEVICE

Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring

Intracerebral Infusion of Autologous CSF

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jeff Elias, MD: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Moosa S, Bond AE, Wang TR, Farzad F, Asthagiri AR, Elias WJ. Stereotactic and Functional Neurosurgery Convection-Enhanced Delivery of Autologous Cerebrospinal Fluid Enhances Basal Ganglia Visualization during MRI-Guided Deep Brain Stimulation Surgery. Stereotact Funct Neurosurg. 2023;101(2):93-100. doi: 10.1159/000528738. Epub 2023 Feb 1.

  PMID: 36724759 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Dr. Jeff Elias
• Organization: University of Virginia

FUSbrain@virginia.edu

(434) 924-0451

Study Officials

• William J Elias, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurological Surgery

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: May 30, 2018
• Study Start: February 13, 2018
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)