NCT03630302

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

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.

Detailed 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.

Conditions

• Parkinson

Interventions

Type	Name	Description
DEVICE	DBS	Deep Brain Stimulation

Timeline

• Start date: 2018-07-12
• Primary completion: 2019-12-31
• Completion: 2020-01-31
• First posted: 2018-08-14
• Last updated: 2021-05-28
• Results posted: 2021-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study