Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder

Parkinson Disease Clinical Trial

— MOPSO PIGD  

Official title:

Multiple Objective Particle Swarm Optimization Postural Instability Gait Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893186
• Other study ID #: NEUR-2019-28436
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 25, 2021
• Est. completion date: July 15, 2027

Study information

• Verified date: May 2024
• Source: University of Minnesota
• Contact: Zuzanna Pasek
• Phone: 612-624-0018
• Email: pasek013[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 15, 2027
• Est. primary completion date: July 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Deep Brain Stimulation, STN
DBS of the STN, within FDA-approved limits and labeling, for symptoms of PD
• GP Deep Brain Stimulation
PD with GP DBS, within FDA-approved limits and labeling, for symptoms of PD.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait test	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	Balance Test	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.
Secondary	Bradykinesia test	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
Secondary	Rigidity Test	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