NCT06872203

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.

Trial Health

55
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 Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

June 1, 2022

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
9 months 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

3.5 years

First QC Date

March 6, 2025

Last Update Submit

March 13, 2025

Conditions

Parkinson Disease, IdiopathicParkinson Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

PD patient

PD patient after receiving a Medtronic DBS implant.

Device: Deep brain stimulation

Interventions

Deep brain stimulationDEVICE

Deep Brain Stimulation programming

PD patient

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • John A Thompson, PhD

    University of Colorado, Denver

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 12, 2025

Study Start

June 1, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)