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NCT05893186 · ClinicalTrials.gov registry record · Early Phase 1
Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder
A Early Phase 1 study of Parkinson Disease, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05893186: Recruiting Early Phase 1 study of Parkinson Disease, sponsored by University of Minnesota.
NCT05893186 is a Early Phase 1 study of Parkinson Disease that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 60 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05893186, a Early Phase 1 study of Parkinson Disease, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Sixty patients will be enrolled in this study who are treated for Parkinson's disease (PD) with bilateral deep brain stimulation of subthalamic nucleus (STN) or globus pallidus (GP), who have a pre- operative 7 Tesla MRI including diffusion tensor imaging for tractography and a postoperative head CT for electrode localization, and in whom at least 3 months have passed since activation of their neurostimulators, for stabilization of clinical stimulator settings. Using their MRI and CT, the investigators will construct patient-specific models of electrical current spread to neuroanatomical tar- gets surrounding the electrode. Then applying nonlinear (particle swarm) optimization, patient- specific stimulator settings will be designed to maximally or minimally activate specific path- ways. In STN DBS: pedunculopallidal vs. pallidopeduncular pathways. In GP DBS: pallidopeduncular pathways at its origin in GP pars interna (GPi) vs. inhibitory afferents to GPi (from GP pars externa GPe). All stimulation falls within the the FDA-approved range for DBS for PD.
Primary Outcome
Subjects walk for one minute each on a treadmill set to match their individual overground walking speed. A forceplate measures the center of pressure trajectory from which integral software detects time and location of heel-strike and toe off events, and from these, plus the treadmill speed, we compute step lengths.
Conditions Studied
Interventions
- OTHER Deep Brain Stimulation, STN
- OTHER GP Deep Brain Stimulation
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-05-25 |
| Est. Completion | 2027-07-15 |
| Phase | Early Phase 1 |
What NCT05893186 shows while recruiting
NCT05893186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 2 interventions - of which Deep Brain Stimulation, STN is the first listed.
NCT05893186 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05893186 about?
NCT05893186 is a clinical study titled "Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder". Sixty patients will be enrolled in this study who are treated for Parkinson's disease (PD) with bilateral deep brain stimulation of subthalamic nucleus (STN) or globus pallidus (GP), who have a pre- operative 7 Tesla MRI including diffusion tensor imaging for tractography and a postoperative head CT...
What is the current status of trial NCT05893186?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 60 participants. The study started on 2021-05-25. Estimated completion is 2027-07-15.
What conditions does trial NCT05893186 study?
This clinical trial studies the following conditions: Parkinson Disease.
What interventions are being tested in trial NCT05893186?
The interventions under investigation include: Deep Brain Stimulation, STN (OTHER), GP Deep Brain Stimulation (OTHER).
Who is sponsoring clinical trial NCT05893186?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05893186 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05893186's enrollment target sits among peer trials
60 125th of 297 higher than 154 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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