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Completed

NCT Number: NCT03630302

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

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.

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Key information

Conditions

Parkinson

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBS

Device

Deep Brain Stimulation

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

    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 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

    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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Baylor College of Medicine
  • University of Houston

Registry information

Acronym: INVENT

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 14, 2018
Registry last updated
May 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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