Adaptive DBS to Offset STN Dysregulation During Exercise in PD

February 29, 2024 updated by: University of Colorado, Denver

Implementation of Adaptive DBS to Offset STN Dysregulation During Exercise and Reduce Exertion in Parkinson's Disease

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria: Persons with PD, who have a Medtronic DBS implant with a Percept IPG.

-

Exclusion Criteria: Persons not meeting the above listed age and implant criteria, who are not able to complete the study exercise, or not able to comprehend and consent to study participation.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PD
Subjects with PD who have an implanted Medtronic DBS system with a Percept IPG.
Device: aDBS
adaptive deep brain stimulation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

February 29, 2024

First Posted (Estimated)

March 6, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0847

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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