Recruiting
Early Phase 1

Observational Study

Sponsor:

University of Minnesota

Code:

NCT05893186

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Deep Brain Stimulation, STN

GP Deep Brain Stimulation

Study Details

Brief summary:

Sixty patients will be enrolled in this study who are treated for Parkinson's disease (PD) with bilateral deep brain stimulation of subthalamic nucleus (STN) or globus pallidus (GP), who have a pre- operative 7 Tesla MRI including diffusion tensor imaging for tractography and a postoperative head CT for electrode localization, and in whom at least 3 months have passed since activation of their neurostimulators, for stabilization of clinical stimulator settings. Using their MRI and CT, the investigators will construct patient-specific models of electrical current spread to neuroanatomical tar- gets surrounding the electrode. Then applying nonlinear (particle swarm) optimization, patient- specific stimulator settings will be designed to maximally or minimally activate specific path- ways. In STN DBS: pedunculopallidal vs. pallidopeduncular pathways. In GP DBS: pallidopeduncular pathways at its origin in GP pars interna (GPi) vs. inhibitory afferents to GPi (from GP pars externa GPe). All stimulation falls within the the FDA-approved range for DBS for PD.

Conditions

Parkinson Disease

Study ID

NCT05893186

Start date

May 25, 2021

Status verified date

May, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Jul 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of PD
  • Bilateral DBS
  • Directional DBS electrode system
  • MRI, at least 7 Tesla, with diffusion tensor imaging, prior to DBS surgery
  • Head CT, at least 1mm cuts, following DBS surgery
  • At least 3 months since initial activation of the neurostimulator

Exclusion Criteria:

  • Neurological or musculoskeletal disorder that significantly affects gait, balance, or limb movements
  • Dementia
  • Prior stereotactic neurosurgery other than DBS for movement disorder
  • Pregnancy

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: STN DBS

Patients with implanted STN DBS leads will be allocated to this group for DBS stimulation of the STN, within FDA-approved limits and labeling, for symptoms of PD.

experimental: GP DBS

Patients with implanted GP DBS leads will be allocated to this group for DBS stimulation of the GP, within FDA-approved limits and labeling, for symptoms of PD.

Interventions

Deep Brain Stimulation, STN

DBS of the STN, within FDA-approved limits and labeling, for symptoms of PD

GP Deep Brain Stimulation

PD with GP DBS, within FDA-approved limits and labeling, for symptoms of PD.

Primary outcome measure

  • Gait test [ Time Frame: 1 minute ]

Central Contacts and Locations

Central contacts

Johanna Caskey, BA

763-353-9470caske039@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Johanna Caskey, BA

763-353-9470caske039@umn.edu

Principal Investigator:

Scott Cooper, MD, PhD

More Information

Sponsor

University of Minnesota

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • Deep Brain Stimulation

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.