Percept Transitions in FOG and PD
Basal Ganglia Contributions to Transitions in Freezing of Gait and Parkinson's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 21 Years to 75 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
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 possible causes and signs of freezing of gait in Parkinson’s disease, when a person suddenly cannot keep walking. It uses an implanted Medtronic Percept device to record brain signals during movement in people with and without freezing. Participants may choose one or more of three experiments involving starting to walk, changing movements, or moving the wrist or foot quickly back and forth.
The purpose of this research is to examine the possible causes and signs of freezing of gait (FOG) secondary to Parkinson's disease (PD). To achieve this, the study will use the novel (on-label and FDA-approved) local field potential (LFP) measuring capability of the Medtronic Percept™ deep brain stimulation (DBS) system to compare oscillatory activity in people who have Parkinson's disease, with and without freezing of gait (FOG). This will be conducted as three separate experiments, participants may volunteer for one or more experiments: Experiment 1: The first experiment will compare LFPs during gait initiation with and without a cue, in people with (PD+FOG) and without FOG (PD-FOG). Experiment 2: The second experiment will compare LFPs during the successful movement transitions vs. freezing-events during a FOG provocation course in people with FOG. Experiment 3: The third experiment will compare LFPs during rapid alternating movements of the wrist and/or foot, in people with and without FOG
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have idiopathic Parkinson’s disease, meaning its cause is unknown.
- Be 21 to 75 years old.
- Be able to walk 50 meters on your own without a cane or other walking aid.
- Have an implanted Medtronic Percept brain stimulation device.
- Have had the device turned on for the first time at least 3 months ago.
- People from undervalued or underrepresented social groups may join.
- Military service members and Department of Defense staff, including civilian workers, may join.
- People with less access to income, housing, or health care may join.
Who can't join
- Have another disease that damages the brain or nerves, such as Lewy body dementia, multiple system atrophy, or Alzheimer’s disease.
- Have a history of seizures or another major brain or nerve disorder that could affect study tasks.
- Have muscle, bone, or joint problems that greatly affect walking or limb movement. You may skip affected tasks but still do others.
- Have neck or back muscle problems, including whiplash, that would affect walking experiments.
- Have vision or balance-system problems that could affect study tasks.
- Have trouble understanding and agreeing to join the study. The study team will check this with one or, if needed, two tests.
- Be pregnant.
- Have problems after surgery or side effects from stimulation that affect safety or study results, such as unwanted muscle tightening.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Diagnosis of idiopathic PD. * Age 21-75 (see Inclusion of Individuals across the Lifespan for justification of age range). * Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters. * Implanted Medtronic Percept TM Device. * At least 3 months since the initial activation of the neurostimulator. * Undervalued, under-represented, or disenfranchised social group may be included. * Active members of the military (service members), DoD personnel (including civilian employees) may be included. * Individual or group that is disadvantaged in the distribution of social goods and services such as income, housing, or healthcare may be included. Exclusion Criteria: * Meet criteria for dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative disorder. * History of seizures or other significant neurological disorders that may affect participation or performance in the study. * History of musculoskeletal disorders that significantly affect walking or movement of limb(s) that would affect the participation in the experimental task (Participants will be excluded from that task, but may participate in other tasks, for example, may be excluded from Experiment 1 if the disorder affects walking, but may still participate in Experiment 3). * History of muscular conditions of the neck and back, including whiplash that would affect walking experiments. * History of visual and/or vestibular conditions that may affect participation or performance in the study. * Reduced capacity to consent. This will be assessed using a 2-stage process. Initially, participants will be tested using the University of California, San Diego, Brief Assessment of Capacity to Consent (UBACC). If concerns are raised from the UBACC test, the individual will be further tested using the MacArthur Competency Assessment Tool. * Pregnant people. * Post-operative complications or adverse effects (e.g. ON stimulation dystonia) that affect patient safety or confound the experiment.
Study sites (1)
MN
- University of Minnesota, Movement Disorders Lab · Minneapolis, MN 55455Madison Aasen, MS · Study contact · 612-505-8325 · aasen056@umn.eduSommer Amundsen-Huffmaster, PhD · Principal investigatorMore trials in Minneapolis