N/A
Completed N=10
Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy
Parkinson
Source: ClinicalTrials.gov NCT03630302 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure — 2; 3; 0; 2 DBS leads
Summary
The current study aims to explore the functional use of LFPs recorded intraoperatively for the optimization of a directional DBS lead programming
Aim-1: To determine whether intraoperative LFPs recorded from the segmented DBS electrode can predict the optimal stimulation parameters.
Aim-2: Compare the therapeutic window for stimulation delivered through directional and conventional leads and determine if the spatiospectral LFP patterns correlate with the presence of stimulation side effects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure |
2; 3; 0; 2; 0; 5 | — |
| SECONDARY Number of DBS Leads With the Highest Side Effect Threshold at 3 Months That Were Consistent With Predictions Derived From LFPs After DBS Implant Procedure |
3; 3; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-70 years
- Ability to provide informed consent
- Diagnosis of idiopathic Parkinson's disease, and DBS consensus team review supporting the placement of STN DBS.
Exclusion Criteria
- Subject is not a surgical candidate;
- In the Investigator's opinion the subject unable to tolerate multiple programming sessions within a single setting;
- Subject unable to comply with the follow-up schedule
Data sourced from ClinicalTrials.gov (NCT03630302). 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.