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

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ClinicalTrials.gov Identifier: NCT03630302
Recruitment Status : Completed
First Posted : August 14, 2018
Results First Posted : May 28, 2021
Last Update Posted : May 28, 2021
Sponsor:
Collaborators:
Baylor College of Medicine
University of Houston
Information provided by (Responsible Party):
Abbott Medical Devices

Study Description
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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.


Condition or disease Intervention/treatment
Parkinson Device: DBS

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.

Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy
Actual Study Start Date : July 12, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: DBS
    Deep Brain Stimulation

Outcome Measures
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Primary Outcome Measures :
  1. Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure [ Time Frame: LFPs were analyzed after DBS implant procedure, clinical programming were done at 3 month followup ]

    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.



Secondary Outcome Measures :
  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 [ Time Frame: LFPs were measured during DBS implant procedure, clinical programming were done at 3 month followup evaluation ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630302


Locations
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United States, Texas
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
Houston, Texas, United States, 77030
Sponsors and Collaborators
Abbott Medical Devices
Baylor College of Medicine
University of Houston
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
Study Protocol and Statistical Analysis Plan  [PDF] September 29, 2017

More Information
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03630302    
Other Study ID Numbers: CRD_931 INVENT
First Posted: August 14, 2018    Key Record Dates
Results First Posted: May 28, 2021
Last Update Posted: May 28, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes