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Completed

NCT Number: NCT03540134

Convection Enhanced Delivery of CSF in DBS for Parkinson's

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

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Key information

Conditions

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

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Intracerebral Infusion of Autologous Cerebral Spinal Fluid

Device

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

Primary outcomes

  1. Number of Participants With Adverse Events That Are Related to Treatment

    Time frame: 6 months postoperatively

    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.

Secondary outcomes

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

    Time frame: 6 months postoperatively in comparison to baseline

    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).

  2. Vd/Vi Ratio

    Time frame: Day of Surgery

    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.

  3. Baseline Levodopa Medication Equivalents (Milligrams)

    Time frame: Baseline

  4. Change in Quality of Life Assessment With PDQ-39 Questionnaire

    Time frame: 6 months postoperatively in comparison to baseline

    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.

Sponsors and collaborators

Lead sponsor

Jeff Elias, MD

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 30, 2018
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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