- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05893186
Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder (MOPSO PIGD)
October 30, 2023 updated by: University of Minnesota
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients will undergo on-label DBS for the treatment of Parkinson's disease, at stimulator settings different from their usual settings, but within the FDA-approved range for this indication, based on patient specific models that identify stimulation settings that most selectively target one pathway over other adjacent pathways.
In Aim 1 (STN DBS), the comparison will be amongst settings that selectively target pedunculopallidal, pallidopeduncular and subthalamopallidal pathways.
In Aim 2 (GP DBS), the comparison will be amongst settings which selectively target the pallidopeduncular pathways at its origin in GP pars interna (GPi), inhibitory afferents to GPi (from GP pars externa GPe), and pallidosubthalamic pathway (from GPe).
Total time, including both test stimulation and off-stimulation time, will be about 6 hours for Arm 1, and about 5 hours for Arm 2. Testing will include quantitative measures of gait, balance, bradykinesia, and rigidity.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zuzanna Pasek
- Phone Number: 612-624-0018
- Email: pasek013@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Recruiting
- University of Minnesota
-
Principal Investigator:
- Scott Cooper, MD, PhD
-
Contact:
- Zuzanna Pasek
- Phone Number: 612-624-0018
- Email: pasek013@umn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of PD
- Bilateral DBS
- Directional DBS electrode system
- MRI, at least 7 Tesla, with diffusion tensor imaging, prior to DBS surgery
- Head CT, at least 1mm cuts, following DBS surgery
- At least 3 months since initial activation of the neurostimulator
Exclusion Criteria:
- Neurological or musculoskeletal disorder that significantly affects gait, balance, or limb movements
- Dementia
- Prior stereotactic neurosurgery other than DBS for movement disorder
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: STN DBS
Patients with implanted STN DBS leads will be allocated to this group for DBS stimulation of the STN, within FDA-approved limits and labeling, for symptoms of PD.
|
DBS of the STN, within FDA-approved limits and labeling, for symptoms of PD
|
Experimental: GP DBS
Patients with implanted GP DBS leads will be allocated to this group for DBS stimulation of the GP, within FDA-approved limits and labeling, for symptoms of PD.
|
PD with GP DBS, within FDA-approved limits and labeling, for symptoms of PD.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait test
Time Frame: 1 minute
|
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.
|
1 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance Test
Time Frame: About 1.5 seconds per trial.
|
Subjects stand on the treadmill, with the treadmill initially motionless.
The treadmill belt then jerks forward, so that the subject must step to recover balance.
Falls are prevented by a safety harness and assisting staff.
A rater logs number of steps taken.
Aggregated as mean of 5 trials.
|
About 1.5 seconds per trial.
|
Bradykinesia test
Time Frame: 30 seconds
|
Subjects sit with forearm supported, grasping a manipulandum which measures pronation/supination angle, making a pronation/supination motion actively for 30 seconds, instructed as big and fast.
Aggregated as root mean square (RMS) of mean-subtracted angle.
|
30 seconds
|
Rigidity Test
Time Frame: 45 seconds
|
Subjects sit with forearm supported, grasping a manipulandum, which is connected to a motor and torque sensor.
The motor rotates the forearm through 40 degress of pronation-supination, cyclically, at 1.5 cycle per second for 45 seconds.
Aggregated as mean absolute value of torque.
|
45 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Scott Cooper, MD, PhD, University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 25, 2021
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2030
Study Registration Dates
First Submitted
May 12, 2023
First Submitted That Met QC Criteria
May 30, 2023
First Posted (Actual)
June 7, 2023
Study Record Updates
Last Update Posted (Actual)
November 1, 2023
Last Update Submitted That Met QC Criteria
October 30, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEUR-2019-28436
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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