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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 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.

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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.

Conditions Studied

Interventions

  • OTHER Deep Brain Stimulation, STN
  • OTHER GP Deep Brain Stimulation

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-05-25
Est. Completion 2027-07-15
Phase Early Phase 1

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT05893186

The ClinicalTrials.gov registry entry for NCT05893186 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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