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Aim 3 Particle Swarm Optimization PIGD

Primary Purpose

Parkinson's Disease and Parkinsonism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DBS
Sponsored by
University of Minnesota
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease and Parkinsonism

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Diagnosis of Parkinson's Disease Bilateral DBS in STN or GP At least 3 months after lead implantation Montreal Cognitive Assessment (MoCA): MoCA=23+ OR: If MoCA score is 23 or less, UBACC will be performed to ensure capacity to consent. If UBACC results are unclear, the MacCAT-CR will be performed. Failed or unclear MacCAT-CR results will exclude the study candidate. Between 18-85 years of age Has undergone pre-operative 7T MRI (as part of protocol #1210M22183 or standard-of-care) and post-operative CT imaging (standard of care). 8.2 Exclusion Criteria: Inability to walk in the off-med, off-stimulation condition (even with safety harness) Gait impaired significantly by a condition other than PD Breaks or shorts in active contacts IPG battery nearing end of life (in patients with primary-cell IPGs) Females who are nursing or pregnant

Sites / Locations

  • University of MinnesotaRecruiting

Outcomes

Primary Outcome Measures

Unified Parkinson's Disease Rating Scale Movement Disorders Society revision, MDS-UPDRS
Difference in scores on MDS-UPDRS

Secondary Outcome Measures

Full Information

First Posted
June 28, 2023
Last Updated
August 29, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05934747
Brief Title
Aim 3 Particle Swarm Optimization PIGD
Official Title
Aim 3 Particle Swarm Optimization Postural Instability Gait Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP.
Detailed Description
In Parkinson's disease (PD) patients undergoing standard-of-care Deep Brain Stimulation (DBS) therapy, to compare the effect on Parkinson's symptoms of two different neurostimulator settings designed to differ from each other as much as possible with respect to how much they activate two different neuroanatomical structures: the axonal pathway from Globus Pallidus (GP) to Pedunculopontine Nucleus (PPN), and the axonal pathway from PPN to GP. In this respect, the present protocol is similar to Protocol STUDY00008644. In fact, that protocol, and this one, cover different Aims of the same NIH-funded project. Protocol STUDY00008644 tested different neurostimulor settings for a few hours in the laboratory only; the present protocol also tests them for two weeks between laboratory testing sessions. This is essential, for several reasons. First, clinically relevant outcome measures, such as ADL (activities of dailly life) and QOL (quality of life) scales require observation for longer than a few hours in the laboratory. Second, DBS effects are not instantaneous, and prolonged observation is required to determine the full effect of neurostimulator settings. Third, we intend, if our hypothesis is confirmed (that activation of the PPN-to-GP pathway is most effective for the postural-instability / gait-disorder (PIGD) complex) to propose a clinical trial of neurostimulator settings designed to maximize activation of this pathway; the present protocol will yield data and experience essential for designing and proposing such a trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease and Parkinsonism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
DBS
Intervention Description
Deep Brain Stimulation
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale Movement Disorders Society revision, MDS-UPDRS
Description
Difference in scores on MDS-UPDRS
Time Frame
1 hour and 2 weeks after intiating stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Diagnosis of Parkinson's Disease Bilateral DBS in STN or GP At least 3 months after lead implantation Montreal Cognitive Assessment (MoCA): MoCA=23+ OR: If MoCA score is 23 or less, UBACC will be performed to ensure capacity to consent. If UBACC results are unclear, the MacCAT-CR will be performed. Failed or unclear MacCAT-CR results will exclude the study candidate. Between 18-85 years of age Has undergone pre-operative 7T MRI (as part of protocol #1210M22183 or standard-of-care) and post-operative CT imaging (standard of care). 8.2 Exclusion Criteria: Inability to walk in the off-med, off-stimulation condition (even with safety harness) Gait impaired significantly by a condition other than PD Breaks or shorts in active contacts IPG battery nearing end of life (in patients with primary-cell IPGs) Females who are nursing or pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Scott Cooper, PhD, MD
Phone
612-626-9516
Email
secooper@umn.edu
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Aim 3 Particle Swarm Optimization PIGD

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