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NCT Number: NCT05893186

Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Johanna Caskey, BA

CONTACT

[email protected]

763-353-9470

Scott Cooper, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

Patients will undergo on-label DBS for the treatment of Parkinson's disease, at stimulator settings different from their usual settings, but within the FDA-approved range for this indication, based on patient specific models that identify stimulation settings that most selectively target one pathway over other adjacent pathways. In Aim 1 (STN DBS), the comparison will be amongst settings that selectively target pedunculopallidal, pallidopeduncular and subthalamopallidal pathways. In Aim 2 (GP DBS), the comparison will be amongst settings which selectively target the pallidopeduncular pathways at its origin in GP pars interna (GPi), inhibitory afferents to GPi (from GP pars externa GPe), and pallidosubthalamic pathway (from GPe). Total time, including both test stimulation and off-stimulation time, will be about 6 hours for Arm 1, and about 5 hours for Arm 2. Testing will include quantitative measures of gait, balance, bradykinesia, and rigidity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Brain Stimulation, STN

Other

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

GP Deep Brain Stimulation

Other

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

Primary outcomes

  1. Gait test

    Time frame: 1 minute

    Subjects walk for one minute each on a treadmill set to match their individual overground walking speed. A forceplate measures the center of pressure trajectory from which integral software detects time and location of heel-strike and toe off events, and from these, plus the treadmill speed, we compute step lengths.

Secondary outcomes

  1. Balance Test

    Time frame: About 1.5 seconds per trial.

    Subjects stand on the treadmill, with the treadmill initially motionless. The treadmill belt then jerks forward, so that the subject must step to recover balance. Falls are prevented by a safety harness and assisting staff. A rater logs number of steps taken. Aggregated as mean of 5 trials.

  2. Bradykinesia test

    Time frame: 30 seconds

    Subjects sit with forearm supported, grasping a manipulandum which measures pronation/supination angle, making a pronation/supination motion actively for 30 seconds, instructed as big and fast. Aggregated as root mean square (RMS) of mean-subtracted angle.

  3. Rigidity Test

    Time frame: 45 seconds

    Subjects sit with forearm supported, grasping a manipulandum, which is connected to a motor and torque sensor. The motor rotates the forearm through 40 degress of pronation-supination, cyclically, at 1.5 cycle per second for 45 seconds. Aggregated as mean absolute value of torque.

Study contacts

Contact information is provided by the study sponsor or research team.

Johanna Caskey, BA

CONTACT

[email protected]

763-353-9470

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Acronym: MOPSO PIGD

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Jun 7, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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