N/A
Completed N=35
DBS Under General Anesthesia: Comparison To The Standard Technique
Source: ClinicalTrials.gov NCT01997398 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: "Off" and "On" Medication Unified Parkinson's Disease Rating III Score (UPDRS) — 48.4; 28.9; 23.52; 22.56 units on a scale — p=<0.001
Summary
There is a growing trend in functional neurosurgery toward direct anatomical targeting for deep brain stimulation (DBS). This study describes a method and reports the initial experience placing DBS electrodes under general anesthesia without the use of microelectrode recordings (MER), using a portable head CT scanner to verify accuracy intra-operatively.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY "Off" and "On" Medication Unified Parkinson's Disease Rating III Score (UPDRS) |
48.4; 28.9; 23.52; 22.56 | <0.001 sig |
| SECONDARY Parkinson's Disease Quality-39 Score (PDQ-39) |
50.3; 42.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patient's who have undergone DBS surgery under general anesthesia without electrophysiology, utilizing a portable head CT scanner to verify accuracy intra-operatively.
Exclusion Criteria
- Patient's who have undergone DBS surgery awake, without general anesthesia and with electrophysiology.
Data sourced from ClinicalTrials.gov (NCT01997398). 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. Informational only — not medical advice.