Percept Transitions in FOG and PD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorUniversity of Minnesota
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- OFF Parkinson's Medication(s)
- OFF Deep Brain Stimulation
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Minnesota
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov