Convection Enhanced Delivery of CSF in DBS for Parkinson's

NCT ID: NCT03540134

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-13
• Study Completion Date: 2018-12-18

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intracerebral Infusion of Autologous CSF

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.

Group Type: EXPERIMENTAL

Intracerebral Infusion of Autologous Cerebral Spinal Fluid

Intervention Type: DEVICE

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

Interventions

Intracerebral Infusion of Autologous Cerebral Spinal Fluid

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jeff Elias, MD

OTHER

Sponsor Role: lead

Responsible Party

Jeff Elias, MD

Professor of Neurological Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

William J Elias, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36724759 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB-HSR #20457

Identifier Type: -

Identifier Source: org_study_id