Adaptive DBS to Offset STN Dysregulation During Exercise... | NCT06296810

Studies
Adaptive DBS to Offset STN Dysregulation During Exercise in PD

NCT06296810

Sponsor

University of Colorado, Denver

Status

Recruiting

Last Update Posted

Mar 17, 2025Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Parkinson Disease

Interventions

aDBS

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

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2024Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Feb 29, 2024

First Submission Date that Met QC Criteria

Feb 29, 2024

First Posted Date

Mar 6, 2024Actual

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

The investigators conduct a prospective study to evaluate the effects of exercise on Parkinson's Disease brain biomarkers detected with the PerceptTM PC neurostimulator.

Detailed Description

The investigators will conduct a prospective study to evaluate the effects of exercise on Local Field Potential biomarkers detected from the subthalmic nuclues in Parkinson's Disease with the PerceptTM PC neurostimulator. Subsequently, adaptive Deep Brain Stimulation applied in response to low beta peak (L-beta; 13-20Hz) will be performed to evaluate feasibility of whether aDBS can offset the effects of exacerbation of parkinsonism during exercise performance and recovery.

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		Subjects with PD who have an implanted Medtronic DBS system with a Percept IPG.	Device: aDBS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aDBS	Device	adaptive deep brain stimulation	PD

Measure	Description	Time Frame
identification of L-beta frequency peak power		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Persons with PD who have a Medtronic DBS Sensight implant and a Percept IPG.

Exclusion Criteria:

Persons not meeting the above listed implant criteria Persons not meeting the age limit criteria Persons who are not able to complete the study exercise Persons not able to comprehend and consent to study participation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Persons with PD, who have a Medtronic DBS Sendight implant and a Percept IPG.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pamela David Gerecht, PhD	Contact	303-724-4134		pamela.davidgerecht@cuanschutz.edu

Overall Officials

Not provided

Locations

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

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