Clinical trial NCT03630302: Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy
Official title: Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Baylor College of Medicine
name: University of Houston
First posted: 2018-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure
timeFrame: LFPs were analyzed after DBS implant procedure, clinical programming were done at 3 month followup
Secondary outcomes:
measure: 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
timeFrame: LFPs were measured during DBS implant procedure, clinical programming were done at 3 month followup evaluation
Other outcomes:
Locations:
city: Houston
country: United States
facility: CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
state: Texas
Study officials:
References: