N/A
N=4
Convection Enhanced Delivery of CSF in DBS for Parkinson's
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT03540134 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Number of Participants With Adverse Events That Are Related to Treatment — 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intracerebral Infusion of Autologous Cerebral Spinal Fluid (Device)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Jeff Elias, MD
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events That Are Related to Treatment |
2 | — |
| SECONDARY % Change in Un-medicated UPDRS, Motor Subsection (Part III) From Baseline to 6 Months |
-18.5 | — |
| SECONDARY Vd/Vi Ratio |
2.69 | — |
| SECONDARY Baseline Levodopa Medication Equivalents (Milligrams) |
1893.3 | — |
| SECONDARY Change in Quality of Life Assessment With PDQ-39 Questionnaire |
-17.75 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03540134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.