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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
| University of Houston | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBS | Device | Deep Brain Stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHI St. Luke's Health Baylor College of Medicine Med. Ctr. | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | LFP Recording Patients | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Surgery |
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| 3 Month Visit |
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| Data Post Analyses |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All patients underwent STN DBS implants |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | patients who had both LFP data and clinical programming results, all patients have bilateral implants | Posted | Count of Units | DBS leads | LFPs were analyzed after DBS implant procedure, clinical programming were done at 3 month followup | DBS leads | DBS leads |
|
surgery to 3 month post-surgery visit
Both motor and non-motor side effect-induced adverse events were examined and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LFP Recording Patients | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increased falls | Injury, poisoning and procedural complications | Other | Systematic Assessment | patient experienced increased gait issues and falls during Med off / stim on scenarios, the patient was withdrawn due to inability to tolerate off medication study assessments |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erika Ross | Abbott neuromodulation | 972-526-8207 | erika.ross@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2017 | Jul 15, 2020 | Prot_SAP_000.pdf |
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| LFPs were measured during DBS implant procedure, clinical programming were done at 3 month followup evaluation |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| How long has the patient been diagnosed with PD | Mean | Standard Deviation | years |
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| OG000 | LFP Analyses From Patients With Bilateral Implants | all DBS leads from all patients that LFP analyses were performed on and clinical programming were obtained |
|
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| Secondary | 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 | 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. | all patients with LFP data and who have gone through 3 month evaluation of side effect thresholds, each with bilateral implants | Posted | Count of Units | DBS leads | LFPs were measured during DBS implant procedure, clinical programming were done at 3 month followup evaluation | DBS leads | DBS leads |
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| 0 |
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
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| cognitive impairment | Psychiatric disorders | Other | Systematic Assessment | patient became confused intraoperatively but surgical procedure was completed as planned. Due to persistent altered mental state, and MRI was ordered and showed bilateral edema |
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