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Aim 3 Particle Swarm Optimization PIGD

Aim 3 Particle Swarm Optimization Postural Instability Gait Disorder

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two deep brain stimulation (DBS) settings to see how they affect Parkinson's symptoms. The settings are designed to affect two nerve paths in the brain as differently as possible. It is for adults with Parkinson's disease who already receive DBS as part of their usual care.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Parkinson's disease.
  • Are 18 to 85 years old.
  • Have DBS on both sides of the brain in areas called the STN or GP.
  • Had the DBS wires placed at least 3 months ago.
  • Score 23 or higher on the MoCA, a thinking and memory test. The rules also call for extra tests at scores of 23 or lower to check that you can understand and agree to join.
  • Had a 7T MRI brain scan before surgery through study protocol #1210M22183 or usual care, and a CT scan after surgery through usual care.

Who can't join

  • Cannot walk when off Parkinson's medicine and with DBS turned off, even with a safety harness.
  • Have a condition other than Parkinson's that greatly affects walking.
  • Have breaks or electrical shorts in active parts of the DBS wires.
  • Have a DBS device with a non-rechargeable battery that is nearly used up.
  • Are pregnant or breastfeeding.
  • Fail the final test of your ability to understand and agree to join, or have unclear results on that test.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

MN