ParkinsonINVENTNCT03630302

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

An observational study of Parkinson, run by Abbott Medical Devices at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Parkinson
What is being tested?: DBS
Type of treatment: Medical device
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 12 Jul 2018to 31 Jan 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
Adult, Older adult

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

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the 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.

Conditions: Parkinson
Being tested: DBS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DBSDevice
Deep Brain Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (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
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.
Measured: LFPs were measured during DBS implant procedure, clinical programming were done at 3 month followup evaluation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 201831 Jan 2020

First posted14 Aug 2018
Study start12 Jul 2018
Primary completion31 Dec 2019
Study completion31 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ParkinsonStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03630302
Sponsor's protocol ID: CRD_931 INVENT
Acronym: INVENT
Status last verified: May 2021
First submitted: 9 Aug 2018
Last updated: 28 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy
ClinicalTrials.gov ID: NCT03630302
Acronym / sponsor ID: INVENT / CRD_931 INVENT
Conditions: Parkinson
Study type: Observational
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Collaborators: Baylor College of Medicine, University of Houston
Study start: 12 Jul 2018 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Jan 2020 (actual)
First posted: 14 Aug 2018 (actual)
Results: Posted 28 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Approximately 15 subjects will be enrolled in this clinical investigation. The clinical investigation will be conducted at 2 centers in the USA.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 to 70 years
Sex: All
Age groups: Adult, Older adult
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

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DBSDeep Brain Stimulation	Device	–

Primary outcome

Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure
Time frame: 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.

1 secondary outcome

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
Time frame: LFPs were measured during DBS implant procedure, clinical programming were done at 3 month followup evaluation

Results and safety

Results posted to the registry on 28 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LFP Recording Patients	10	9

Primary outcome: Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure

Time frame: LFPs were analyzed after DBS implant procedure, clinical programming were done at 3 month followup. Count of units. Unit: DBS leads

Measure	LFP Analyses From Patients With Bilateral Implants n = 5
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

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: surgery to 3 month post-surgery visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LFP Recording Patients	0 of 10 (0%)	2 of 10 (20%)	0 of 10

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
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RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson, run by Abbott Medical Devices at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of DBS Leads With Clinical Programming at 3 Months That Were Consistent With Predictions Via LFP Features After DBS Implant Procedure (time frame: LFPs were analyzed after DBS implant procedure, clinical programming were done at 3 month followup). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03630302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.