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

Parkinson Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03630302
Study type Observational
Source Abbott Medical Devices
Contact
Status Completed
Phase
Start date July 12, 2018
Completion date January 31, 2020
View Details
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