Recruiting

DBS Settings

Sponsor:

University of Minnesota

Code:

NCT05934747

Conditions

Parkinson's Disease and Parkinsonism

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

DBS

Study Details

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.

Conditions

Parkinson's Disease and Parkinsonism

Study ID

NCT05934747

Start date

Mar 19, 2024

Status verified date

May, 2026

Completion date

Jan 5, 2030

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • Diagnosis of Parkinson's Disease
  • Bilateral DBS in STN or GP
  • At least 3 months after lead implantation
  • Montreal Cognitive Assessment (MoCA):

MoCA=23+

OR: If MoCA score is 23 or less, UBACC will be performed to ensure capacity to consent. If UBACC results are unclear, the MacCAT-CR will be performed. Failed or unclear MacCAT-CR results will exclude the study candidate.

  • Between 18-85 years of age
  • Has undergone pre-operative 7T MRI (as part of protocol #1210M22183 or standard-of-care) and post-operative CT imaging (standard of care).

8.2 Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

DBS

Deep Brain Stimulation

Primary outcome measure

  • Unified Parkinson's Disease Rating Scale Movement Disorders Society revision, MDS-UPDRS [ Time Frame: 1 hour and 2 weeks after intiating stimulation ]

Central Contacts and Locations

Central contacts

Johanna Caskey, BA

763-353-9470caske039@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

More Information

Sponsor

University of Minnesota

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-05-08.