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Comparing ways to set an implanted brain stimulator

Researchers compare two sets of stimulation settings and their effects on Parkinson’s symptoms in people receiving usual brain stimulation care.

Testing a treatment or activity · Study reference: NCT05934747

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

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Start (reported actual date)
2024-03-19
Main measurements finished (planned)
2028-06-01
Study finished (planned)
2030-01-05

Planned dates can move. A study finishing does not tell us when a paper will be published.

No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.

Changes we have recorded
  • 2026-10-11 — recruiting

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.

Who can join?

Ages 18 years to 85 years · Does not accept healthy volunteers

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Read all the rules for taking part

Sex eligibility reported by registry: all

* 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
Full study name & original research details

Official study title

Aim 3 Particle Swarm Optimization Postural Instability Gait Disorder

Short title used by the registry

Aim 3 Particle Swarm Optimization PIGD

Original 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.

Further description from the registry

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. In this respect, the present protocol is similar to Protocol STUDY00008644. In fact, that protocol, and this one, cover different Aims of the same NIH-funded project. Protocol STUDY00008644 tested different neurostimulor settings for a few hours in the laboratory only; the present protocol also tests them for two weeks between laboratory testing sessions. This is essential, for several reasons. First, clinically relevant outcome measures, such as ADL (activities of dailly life) and QOL (quality of life) scales require observation for longer than a few hours in the laboratory. Second, DBS effects are not instantaneous, and prolonged observation is required to determine the full effect of neurostimulator settings. Third, we intend, if our hypothesis is confirmed (that activation of the PPN-to-GP pathway is most effective for the postural-instability / gait-disorder (PIGD) complex) to propose a clinical trial of neurostimulator settings designed to maximize activation of this pathway; the present protocol will yield data and experience essential for designing and proposing such a trial.

Conditions reported: Parkinson's Disease and Parkinsonism

Registry records for this study

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Study type
Interventional
Interventions
DBS
Phases
NA
Sponsor
University of Minnesota
Start date reported by registry
2024-03-19 (actual)

Registry updated: 2026-05-08 · Status last verified by the registry submitter: 2026-05

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Johanna Caskey, BA · 763-353-9470 · caske039@umn.edu

Study locations

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University of Minnesota

Minneapolis, Minnesota, United States

Recruiting

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.