Trial Outcomes & Findings for Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy (NCT NCT03630302)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

LFPs were analyzed after DBS implant procedure, clinical programming were done at 3 month followup

Results posted on

2021-05-28

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Surgery STARTED	10
Surgery COMPLETED	9
Surgery NOT COMPLETED	1
3 Month Visit STARTED	9
3 Month Visit COMPLETED	7
3 Month Visit NOT COMPLETED	2
Data Post Analyses STARTED	7
Data Post Analyses COMPLETED	5
Data Post Analyses NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Surgery hardware issue prevented LFP recordings	1
3 Month Visit Adverse Event	2
Data Post Analyses IRB issues prevented data from being analyzed and transferred	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Patients n=10 Participants All patients underwent STN DBS implants
Age, Continuous	59.3 years STANDARD_DEVIATION 5.9 • n=10 Participants
Sex: Female, Male Female	4 Participants n=10 Participants
Sex: Female, Male Male	6 Participants n=10 Participants
How long has the patient been diagnosed with PD	8.95 years STANDARD_DEVIATION 4.11 • n=10 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	LFP Analyses From Patients With Bilateral Implants n=10 DBS leads all DBS leads from all patients that LFP analyses were performed on and clinical programming were obtained
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
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
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
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
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
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 outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	LFP Analyses From Patients With Bilateral Implants n=10 DBS leads all DBS leads from all patients that LFP analyses were performed on and clinical programming were obtained
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
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
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

Adverse Events

LFP Recording Patients

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	LFP Recording Patients n=10 participants at risk 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.
Injury, poisoning and procedural complications increased falls	10.0% 1/10 • Number of events 1 • surgery to 3 month post-surgery visit Both motor and non-motor side effect-induced adverse events were examined and reported.
Psychiatric disorders cognitive impairment	10.0% 1/10 • Number of events 1 • surgery to 3 month post-surgery visit Both motor and non-motor side effect-induced adverse events were examined and reported.

Additional Information

Erika Ross

Abbott neuromodulation

Phone: 972-526-8207

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place