RightFit
RecruitingPhase not listed

Udall Project 2 Aim 2A&C

Mechanisms and Effects of Pallidal Deep Brain Stimulation on Levodopa Resistant Motor Signs in Parkinson's Disease; Udall Project 2 Aim 2A&C

Who can join

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

Age
No age limits stated
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

Not stated in the study description — ask the study team about visits and procedures.

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 looks at how deep brain stimulation (DBS) affects movement, balance, walking, and brain signals as its effects wear off and return. It is for people with Parkinson’s disease who have a Medtronic Percept DBS device. The study also tracks walking and brain signals during daily life for at least 4 weeks.

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.

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

Eligibility

Who can join

  • Receive DBS in the globus pallidus, a part of the brain, to treat Parkinson’s disease.
  • Have a Medtronic Percept DBS device.
  • Have had the DBS device turned on for at least 3 months.
  • For the at-home part only: have DBS settings that allow the device to record brain signals.

Who can't join

  • Have a history of muscle, bone, or joint problems that greatly limit your ability to do the study’s movement tasks.
  • Have a history of dementia or problems with memory or thinking.
  • Have another major brain or nerve disorder, as judged by the lead researcher.
  • Have problems after surgery or side effects that could make participation unsafe or affect study results, such as muscle spasms when stimulation is on.
  • Cannot give informed consent, based on a test of your ability to understand and decide about joining the study.

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

Official eligibility criteria

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 sites (1)

MN