Convection Enhanced Delivery of CSF in DBS for Parkinson's

Completed · Not applicable

Conditions studied: Parkinson Disease

In brief

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

Key facts

Study ID

NCT03540134

Run by

Jeff Elias, MD

People needed

4

Starts

2018-02-13

Expected to finish

2018-12-18

Last updated by the study team

2021-04-08

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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