NCT05934747 · University of Minnesota
Aim 3 Particle Swarm Optimization PIGD
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
DBS
Deep Brain Stimulation
Primary outcome measures
Unified Parkinson's Disease Rating Scale Movement Disorders Society revision, MDS-UPDRS
Time frame: 1 hour and 2 weeks after intiating stimulation
Difference in scores on MDS-UPDRS
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
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
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 8, 2026 · Source of record for eligibility and locations