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

NCT03630302 | Completed Results FDA Device

• 1 other identifier: CRD_931 INVENT
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  LFPs were measured during DBS implant procedure, clinical programming were done at 3 month followup evaluation

Interventions

DBS DEVICE

Deep Brain Stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this study the investigators will explore the predictive capacity of LFPs recorded from STN. In total, 15 patients undergoing bilateral STN DBS will be enrolled for this investigation over a 1-year period. The current surgical case load at BCM supports this level of enrollment. The details of implantation procedures and blinded trial design are given in the following sections

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

Sponsors & Collaborators

• Abbott Medical Devices: lead
• Baylor College of Medicine: collaborator
• University of Houston: collaborator

Study Sites (1)

CHI St. Luke's Health Baylor College of Medicine Med. Ctr.

Houston, Texas, 77030, United States

Location

Limitations and Caveats

Medications/anesthesia could have an important effect on the LFP signal characteristic. For this reason local anesthesia should be used, as administration of anesthesia like propofol can wipe out or change the frequency spectrum of LFPs dramatically.

Results Point of Contact

• Title: Erika Ross
• Organization: Abbott neuromodulation

erika.ross@abbott.com

972-526-8207

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: July 12, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 31, 2020
• Last Updated: May 28, 2021
• Results First Posted: May 28, 2021

Record last verified: 2021-05

Locations

US (1)