Freezing of Gait study: OFF Parkinson's Medication vs OFF Deep Brain Stimulation
Official title Percept Transitions in FOG and PD
ClinicalTrials.gov ID: NCT06848205
What this study is testing
- What it's testing
- The study aims to discover what causes and signals freezing of gait in Parkinson's disease by measuring brain activity with a special implanted device.
- Who it's for
- People with Parkinson's disease, both those who experience freezing of gait and those who do not.
- What's involved
- Participants will have the Medtronic Percept deep brain stimulation system record brain signals while they walk, respond to cues, and perform quick wrist or foot movements. They may join one or more of three short experiments.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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.
See the full eligibility 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.
- 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...
- 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).
- Pregnant people.
- Post-operative complications or adverse effects (e.g. ON stimulation dystonia) that affect patient safety or confound the experiment.
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.