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

Parkinson Clinical Trial

— INVENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03630302
• Other study ID #: CRD_931 INVENT
• Status: Completed
• Start date: July 12, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: May 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 31, 2020
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson

Intervention

Device:
• DBS
Deep Brain Stimulation

Locations

Country	Name	City	State
United States	CHI St. Luke's Health Baylor College of Medicine Med. Ctr.	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Abbott Medical Devices	Baylor College of Medicine, University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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