Clinical trial NCT05774041: Visualization of the STN and GPi for DBS
Official title: Visualization of the STN and GPi for DBS Surgery in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Deep Brain Stimulation
Parkinson Disease
Keywords: Subthalamic nucleus
Globus pallidus
DBS
Lead sponsor: Surgical Information Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with idiopathic Parkinson's Disease indicated for de novo bilateral DBS surgery implant in the STN or GPi will be considered for study participation.

Brief summary: The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System.

Detailed description: This is a prospective, controlled, open-label, multicenter post-market trial to compare standard of care DBS surgery to standard of care plus visualization with the SIS System. The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System.

Parkinson's Disease subjects indicated for DBS will undergo standard DBS surgery with preoperative planning for targeting of STN or GPi as indicated. Subjects will be followed through six months after initial DBS programming to collect clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Subject is diagnosed with Idiopathic Parkinson's Disease and is indicated for de novo DBS surgery with bilateral DBS leads implanted in the STN or GPi.
* Subject is 18 years or older.
* Subject must be able and willing to provide informed consent and comply with study follow-up schedule and procedures.

Exclusion Criteria:

* Subject is not a DBS surgical candidate due to untreated, clinically significant depression, current suicidal ideation, or dementia or any neuropsychological condition or finding that would contraindicate DBS surgery.
* Subject had prior intracranial surgery or other implanted neurostimulators or drug delivery pumps.
* Subject's life expectancy is less than one year.
* Subject is Hoehn and Yahr stage 4-5 in the medication OFF condition.
* Subject is pregnant or interested in becoming pregnant during the duration of the study.
* Subject is currently enrolled in another clinical study utilizing investigational medications, devices, or treatment that would conflict with this protocol.

Primary outcomes:
measure: Measure Euclidean distance (mm) between the planned target coordinate and actual implanted coordinate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
measure: Proportion of patients(%) with procedure-related adverse events, average duration of DBS surgery (hours:minutes), and percentage of cases in which intra-operative testing was performed
timeFrame: 1 month
measure: Compare width of the therapeutic window (the electrical current at which a sustained side effect occurs minus the electrical current at which a meaningful therapeutic benefit was observed)
timeFrame: 6 months
measure: Change in average levodopa equivalent daily dosage (mg)
timeFrame: 6 months
measure: Change in mean score of the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III
timeFrame: 6 months
measure: Rate (%) of stimulation-related side effects
timeFrame: 6 months
measure: Compare percentage of motor benefit from MDS-UPDRS Part III to implanted lead location
timeFrame: 6 months
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Hershey
country: United States
facility: Penn State University
state: Pennsylvania
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
References: