NCT05934747

Brief Summary

In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
14mo left

Started Mar 2024

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress65%
Mar 2024Jun 2027

First Submitted

Initial submission to the registry

June 28, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 7, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

March 19, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

June 28, 2023

Last Update Submit

September 8, 2025

Conditions

Parkinson's Disease and Parkinsonism

Outcome Measures

Primary Outcomes (1)

  • Unified Parkinson's Disease Rating Scale Movement Disorders Society revision, MDS-UPDRS

    Difference in scores on MDS-UPDRS

    1 hour and 2 weeks after intiating stimulation

Interventions

DBSDEVICE

Deep Brain Stimulation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Inability to walk in the off-med, off-stimulation condition (even with safety harness)
  • Gait impaired significantly by a condition other than PD
  • Breaks or shorts in active contacts
  • IPG battery nearing end of life (in patients with primary-cell IPGs)
  • Females who are nursing or pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Johanna Caskey, BA

CONTACT

763-353-9470caske039@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 7, 2023

Study Start

March 19, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations

US(1)