Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a feasibility study designed to evaluate the usefulness of intraoperative LFP recordings obtained from the implanted DBS lead to predict ideal stimulation parameters. Additionally this study will 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. Approximately 15 subjects will be enrolled in this clinical investigation. The clinical investigation will be conducted at 2 centers in the USA. Subjects participating in this clinical investigation will monitored during DBS implant procedure and programming. The expected duration of enrollment is 8 months. The total duration of the clinical investigation is expected to be 1 year.

Official Title
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Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy

Conditions
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Parkinson

Intervention / Treatment
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* Device: DBS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: DBS|Deep Brain Stimulation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure | From all DBS leads (2 per patient): Local field potentials (LFPs) were measured intraoperatively during DBS implant. Features such as beta band power (10-30Hz), high-frequency oscillation power (200-400Hz, HFO), as well as the cross frequency coupling between beta band power and HFO (CFC) were extracted from the LFP recordings from all electrodes. Electrodes with the most beta band power, most HFOs, and most CFC were documented. At 3 month post-op visit, the clinically programmed stimulation electrodes were documented, and were compared to the electrodes documented from the intraoperative LFP measures. Both matches in the exact contact and the row at which the contacts were in were documented and compared. | LFPs were analyzed after DBS implant procedure, clinical programming were done at 3 month followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From all DBS leads (2 per patient): Local field potentials (LFPs) were measured intraoperatively during DBS implant. Features such as beta band power (10-30Hz), high-frequency oscillation power (200-400Hz, HFO), as well as the cross frequency coupling between beta band power and HFO (CFC) were extracted from the LFP recordings from all electrodes. Electrodes with the most beta band power, most HFOs, and most CFC were documented. At 3 month post-op visit, the stimulation electrode that produced the largest side effect threshold (any side effect) were documented, and were compared to the electrodes with the largest beta band, HFO, and CFC power documented from the intraoperative LFP measures. | LFPs were measured during DBS implant procedure, clinical programming were done at 3 month followup evaluation |