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

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03630302
• Collaborator: Baylor College of Medicine (Other), University of Houston (Other)
• Enrollment: 10
• Location: 1
• Actual Duration (Months): 18.7
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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	Phase
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

• 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: Jul 12, 2018
• Actual Primary Completion Date: Dec 31, 2019
• Actual Study Completion Date: Jan 31, 2020

Outcome Measures

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 [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 29, 2017

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03630302
• Other Study ID Numbers: CRD_931 INVENT
• First Posted: Aug 14, 2018
• Last Update Posted: May 28, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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

Study Results

Participant Flow

Arm/Group Title	LFP Recording Patients
Arm/Group Description	All patients underwent STN DBS implants. The DBS leads were programmed by clinicians at initial visit and symptoms re-evaluated at 3 month post-operative visit. Local field potentials (LFPs) were recorded from 9 patients during the surgery of DBS implants. Hardware issue prevented LFP recordings from 1 patient.
Period Title: Surgery
STARTED	10
COMPLETED	9
NOT COMPLETED	1
Period Title: Surgery
STARTED	9
COMPLETED	7
NOT COMPLETED	2
Period Title: Surgery
STARTED	7
COMPLETED	5
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	All Patients
Arm/Group Description	All patients underwent STN DBS implants
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.3 (5.9)
Sex: Female, Male (Count of Participants)
Female	4 40%
Male	6 60%
Race and Ethnicity Not Collected (Count of Participants)
How long has the patient been diagnosed with PD (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.95 (4.11)

Outcome Measures

1. Primary Outcome

Title	Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure
Description	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.
Time Frame	LFPs were analyzed after DBS implant procedure, clinical programming were done at 3 month followup

Outcome Measure Data

Analysis Population Description

patients who had both LFP data and clinical programming results, all patients have bilateral implants

Arm/Group Title	LFP Analyses From Patients With Bilateral Implants
Arm/Group Description	all DBS leads from all patients that LFP analyses were performed on and clinical programming were obtained
Measure Participants	5
Measure DBS leads	10
DBS leads that had clinical programming contact that matched highest beta-band power	2
DBS leads that had clinical programming row that matched highest beta-band power	3
DBS leads that had clinical programming electrode that matched highest HFO power	0
DBS leads that had clinical programming row that matched highest HFO power	2
DBS leads that had clinical programming electrode that matched highest CFC	0
DBS leads that had clinical programming row that matched highest CFC	5

2. Secondary Outcome

Title	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
Description	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.
Time Frame	LFPs were measured during DBS implant procedure, clinical programming were done at 3 month followup evaluation

Outcome Measure Data

Analysis Population Description

all patients with LFP data and who have gone through 3 month evaluation of side effect thresholds, each with bilateral implants

Arm/Group Title	LFP Analyses From Patients With Bilateral Implants
Arm/Group Description	all DBS leads from all patients that LFP analyses were performed on and clinical programming were obtained
Measure Participants	5
Measure DBS leads	10
DBS leads that had highest side effect threshold contact predicted by HFO	3
DBS leads that had highest side effect threshold contact predicted by CFC	3
DBS leads that had highest side effect threshold contact predicted by beta-band power	2

Adverse Events

Time Frame	surgery to 3 month post-surgery visit
Adverse Event Reporting Description	Both motor and non-motor side effect-induced adverse events were examined and reported.
Arm/Group Title	LFP Recording Patients
Arm/Group Description	All patients underwent STN DBS implants, 9/10 patients obtained LFP recordings during surgery. The 9 patients were then revisited for 3 month post-op followup.
All Cause Mortality
	LFP Recording Patients
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	LFP Recording Patients
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	LFP Recording Patients
	Affected / at Risk (%)	# Events
Total	2/10 (20%)
Injury, poisoning and procedural complications
increased falls	1/10 (10%)	1
Psychiatric disorders
cognitive impairment	1/10 (10%)	1

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.