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

Completed

Conditions studied: Parkinson

In brief

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.

Key facts

Study ID

NCT03630302

Run by

Abbott Medical Devices

People needed

10

Starts

2018-07-12

Expected to finish

2020-01-31

Last updated by the study team

2021-05-28

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• CHI St. Luke's Health Baylor College of Medicine Med. Ctr. — Houston, Texas, United States

Full record on ClinicalTrials.gov

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