Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT05656586

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

observational-- no intervention

Study Details

Brief summary:

This protocol will leverage the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC or RC DBS system to study the effects of globus pallidus internus, globus pallidus externus (GPi, GPe), and subthalamic nucleus (STN) DBS on: the wash-out and wash-in dynamics of motor behavior and local field potentials (LFPs) and correlations between fluctuations in gait and LFPs during activities of daily living (recorded over a minimum of 4 weeks). These experiments will elucidate the relationships between LFPs oscillations, lower limb function, postural control and gait performance.

Conditions

Parkinson Disease

Study ID

NCT05656586

Start date

Jan 1, 2023

Status verified date

Feb, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Receiving DBS therapy in GP for treatment of PD
  • Implanted with Medtronic Percept DBS system
  • At least 3 months since initial activation of the neurostimulator
  • For the "At Home" experiment only: participants with DBS settings that are sensing compatible.

Exclusion Criteria:

  • history of musculoskeletal disorders that significantly affects the ability to perform the motor tasks in the specific experiment in question
  • history of dementia or cognitive impairment
  • other significant neurological disorder as determined by the PI
  • post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment
  • lack of capacity to consent (as identified by MaCAT-CR)

Study Design

Enrollment

36 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants

Inclusion criteria for all aims/experiments

  • Receiving DBS therapy in GP or STN for treatment of PD
  • Implanted with Medtronic Percept DBS system
  • At least 3 months since initial activation of the neurostimulator

Interventions

observational-- no intervention

observational

Primary outcome measure

  • Peak negative power [ Time Frame: 30 day ]
  • Stride length [ Time Frame: 30 days ]
  • Alpha power during standardized daily gait assessment [ Time Frame: 30 days ]
  • cadence [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Colum Mackinnon, PhD

612-625-8938cmackinn@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Johanna Caskey

763-353-9470caske039@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Mar 3, 2026

Last verified

Feb, 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 2026-03-03.