LFP Sensing From Directional Leads in the Acute Clinical... | NCT06872203

Studies
LFP Sensing From Directional Leads in the Acute Clinical Setting

NCT06872203

Sponsor

University of Colorado, Denver

Status

Enrolling by invitation

Last Update Posted

Mar 17, 2025Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Parkinson Disease, Idiopathic
Parkinson Disease

Interventions

Deep brain stimulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2022Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Mar 6, 2025

First Submission Date that Met QC Criteria

Mar 6, 2025

First Posted Date

Mar 12, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2025

Last Update Posted Date

Mar 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study plans to learn more about the optimal way to program the Medtronic Deep Brain Stimulation system in patients with Parkinson's Disease.

Detailed Description

The investigators will conduct a prospective study in patients with Parkinson's disease (PD) implanted with standard of care, subthalamic nucleus (STN) deep brain stimulation (DBS) electrodes, to test whether monopolar sensing of the maximal power in the beta frequency range (in STN) predicts the optimal therapeutic stimulation setting for alleviation of PD motor symptoms. Participants in this study will have been implanted with a Medtronic DBS system consisting of a PerceptTM PC neurostimulator (battery) and SenSight™ DBS leads (implanted electrodes) with BrainSenseTM technology. The DBS surgery is a standard of care procedure, and no alteration of the surgical plan will occur for research purposes . The ranked response between the clinical profile (therapeutic benefit and adverse effects) and beta power will be compared for all electrical contacts on the implanted electrode. Additional analysis of monopolar sensing compared to differential bipolar sensing, location/distance and volume of neural activation (VNA) of optimal contacts identified by beta power or therapeutic window will be estimated with respect to the STN.

Aim 1- Determine whether monopolar sensing of beta power, in the outpatient clinic setting, will predict the optimal therapeutic contact for electrical stimulation of the STN.

Aim 2 - Long Term Follow Up (>12 months) of the same consented study participants to determine the stability of the beta power to determine the optimal contact for therapeutic stimulation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PD patient		PD patient after receiving a Medtronic DBS implant.	Device: Deep brain stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Deep brain stimulation	Device	Deep Brain Stimulation programming	PD patient

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare beta frequency power to the TW of each contact.	Contacts will be ranked from highest to lowest in beta frequency power and compared to the rankings of the TW from largest to least. It is hypothesized that there will NOT be a statistically significant difference between the ranks for beta power and TW. This would indicate that the contact with the highest beta frequency power also had the largest TW and the converse also being evident.	2 study visits of 4 hours each, one week apart.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Parkinson's Disease, scheduled to undergo bilateral subthalamic nucleus (STN) Deep Brain Stimulation (DBS) surgery at the University of Colorado Hospital, chosen to have a Medtronic Deep Brain Stimulation system implanted (Percept™ battery & SenSight™ electrode). Parkinson's Disease causes upper extremity bradykinesia (slowness of movement) with a MDS-UPDRS1score of 2 or higher when you are off your PD medications.

Exclusion Criteria: Dementia or other psychological disorders that precludes consent to participate. Inability to follow testing procedures as determined by the study doctor. Inability to be OFF medication for study visits. Existing implanted Deep Brain Stimulation system or implanted cardiac device. Unilateral Medtronic DBS system, or programming not occurring at the University of Colorado Hospital.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

PD patients undergoing implantation of Medtronic DBS system; Sensight(TM) lead and Percept (TM) battery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John A Thompson, PhD	University of Colorado, Denver	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado		Aurora	Colorado	80045	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D046690	Deep Brain Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided