NCT06296810

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

February 29, 2024

Last Update Submit

March 13, 2025

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • identification of L-beta frequency peak power

    4 weeks

Study Arms (1)

PD

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

Device: aDBS

Interventions

aDBSDEVICE

adaptive deep brain stimulation

PD

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Pamela David Gerecht, PhD

CONTACT

303-724-4134pamela.davidgerecht@cuanschutz.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 6, 2024

Study Start

September 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 17, 2025

Record last verified: 2025-03

Locations

US(1)