Parkinson
Conditions
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.
Interventions
DEVICEDBS
Deep Brain Stimulation
Sponsors
Baylor College of Medicine
University of Houston
Abbott Medical Devices
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Patients All patients underwent STN DBS implants | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 3 Month Visit | Adverse Event | 2 |
| Data Post Analyses | IRB issues prevented data from being analyzed and transferred | 2 |
| Surgery | hardware issue prevented LFP recordings | 1 |
Baseline characteristics
| Characteristic | All Patients | — |
|---|---|---|
| Age, Continuous | 59.3 years STANDARD_DEVIATION 5.9 | — |
| How long has the patient been diagnosed with PD | 8.95 years STANDARD_DEVIATION 4.11 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: LFPs were analyzed after DBS implant procedure, clinical programming were done at 3 month followup
Population: patients who had both LFP data and clinical programming results, all patients have bilateral implants
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| LFP Analyses From Patients With Bilateral Implants | Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure | DBS leads that had clinical programming contact that matched highest beta-band power | 2 DBS leads |
| LFP Analyses From Patients With Bilateral Implants | Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure | DBS leads that had clinical programming row that matched highest beta-band power | 3 DBS leads |
| LFP Analyses From Patients With Bilateral Implants | Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure | DBS leads that had clinical programming electrode that matched highest HFO power | 0 DBS leads |
| LFP Analyses From Patients With Bilateral Implants | Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure | DBS leads that had clinical programming row that matched highest HFO power | 2 DBS leads |
| LFP Analyses From Patients With Bilateral Implants | Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure | DBS leads that had clinical programming electrode that matched highest CFC | 0 DBS leads |
| LFP Analyses From Patients With Bilateral Implants | Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure | DBS leads that had clinical programming row that matched highest CFC | 5 DBS leads |
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.
Time frame: LFPs were measured during DBS implant procedure, clinical programming were done at 3 month followup evaluation
Population: all patients with LFP data and who have gone through 3 month evaluation of side effect thresholds, each with bilateral implants
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| LFP Analyses From Patients With Bilateral Implants | 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 | DBS leads that had highest side effect threshold contact predicted by HFO | 3 DBS leads |
| LFP Analyses From Patients With Bilateral Implants | 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 | DBS leads that had highest side effect threshold contact predicted by CFC | 3 DBS leads |
| LFP Analyses From Patients With Bilateral Implants | 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 | DBS leads that had highest side effect threshold contact predicted by beta-band power | 2 DBS leads |