Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
The purpose of this study is to learn how brain signals are related to freezing of gait (FOG) and balance problems in Parkinson's disease (PD) and to study how different deep brain stimulation (DBS) settings may affect these symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
You have been diagnosed with Parkinson's disease
You already have a deep brain stimulation (DBS) device implanted as part of your medical care - specifically, the Medtronic Percept DBS device
Your DBS settings have been stable for at least 3 months
You experience freezing of gait (sudden inability to move your feet when trying to walk)
Disqualifiers
You have a neurological condition other than Parkinson's disease (such as stroke or multiple sclerosis)
You have been diagnosed with dementia or have difficulty understanding the study or giving consent
You currently have alcohol or substance abuse problems
You have hearing or vision problems that would make it difficult to use a virtual reality headset
Trial design
Design model
Single group
Treatments tested in this trial
Multiple Deep Brain Stimulation (DBS) Conditions
Other interventionParticipants have the Medtronic Percept DBS system implanted as part of standard clinical care. During study sessions, stimulation is evaluated under different conditions, including clinically optimized stimulation, off stimulation, and alternative stimulation paradigms. Stimulation settings are temporarily adjusted for research assessments and are returned to clinically optimized settings at the end of each session. Effects of those conditions on task performance are being assessed.
Moving Overground in a Virtual Environment (MOVE)
BehavioralParticipants complete walking and balance tasks within a virtual reality environment designed to simulate real-world situations that provoke gait disturbances. Tasks include navigating environmental constraints, performing turning and stopping movements, and completing dual-task cognitive challenges while walking.
Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait)
BehavioralParticipants complete stair ambulation and functional mobility tasks on an instrumented platform, including ascending and descending steps, walking, turning, and performing dual-task conditions. These assessments provide quantitative measures of gait performance, balance, and functional mobility.
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Participants With Parkinson Disease Undergoing Multi-Condition DBS AssessmentsExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Change in STN-LFP power fluctuations from single-task walking compared to FOG episode
Participants will complete motor, cognitive and dual-task modules in a virtual reality environment that simulates a home-setting, allowing for acquisition of real-world, at-home behavior. They will also complete a stair navigation task under both single and dual-task conditions. During these assessments, neural activity (i.e., subthalamic nucleus local field potentials (STN-LFPs)) will be recorded from the Medtronic Percept Deep Brain Stimulation system. Freezing of gait (FOG) episodes will be marked by a clinician, and change in STN-LFP power fluctuations from single-task walking compared to FOG episodes will be analyzed as the primary outcome.
Time frame
Five sessions completed from enrollment to the end of testing, over an average of one week.Secondary outcomes
1
Number of FOG episodes during the MOVE system modules under each of the four DBS conditions
Participants will complete motor, cognitive and dual-task modules in a virtual reality setting, Moving Overground in Virtual Environments (MOVE). The MOVE system simulates a home-setting, allowing for acquisition of real-world, at-home behavior. It consists of four modules: 1) Reference, 2) Physical, 3) Anxiety, 4) Cognitive (dual-task). Freezing of gait (FOG) episodes usually occur under stressful circumstances which can be grouped into three broad categories: changes in physical environment, anxiety-provoking situations and dual-task environments. The modules in the MOVE system are designed to elicit FOG episodes in a research setting. FOG episodes will be marked by a clinician, and the number of episodes under each of the four DBS conditions will be compared.
Time frame
Five sessions completed from enrollment to the end of testing, over an average of one week.2
Overall time for SAFE-Gait task
Participants will complete the Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait). The SAFE-Gait test requires participants to 1) ascend 3 standard steps, 2) walk on a flat surface for 3 meters, 3) turn and 4) walk back to the starting position which requires descending 3 steps. The time to complete this task will be recorded and compared for all tested DBS conditions.
Time frame
Five sessions completed from enrollment to the end of testing, over an average of one week.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Cleveland Clinic
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov
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