Percept Transitions in FOG and PD

Launched by UNIVERSITY OF MINNESOTA · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial, called Percept Transitions in FOG and PD, is focused on understanding freezing of gait (FOG) in people with Parkinson's disease (PD). Freezing of gait is when someone suddenly feels like their feet are glued to the floor, making it hard to walk. The researchers will use a special device called the Medtronic Percept™ deep brain stimulation system to measure brain activity in participants with and without FOG during different walking tasks. The study consists of three parts: comparing brain activity during walking with and without cues, analyzing movements during freezing events, and looking at rapid wrist and foot movements.

To be eligible for this trial, participants need to be between 21 and 75 years old, have a diagnosis of Parkinson's disease, and be able to walk independently for at least 50 meters. They should also have the Medtronic Percept™ device implanted for at least three months. People who have certain other neurological disorders or significant walking difficulties may not be able to participate. The study is not yet recruiting participants, but those who do take part can expect to contribute valuable information that may help improve understanding and treatment of freezing of gait in Parkinson's disease.

Gender

ALL

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.