Deep Brain Stimulation, Parkinson Disease
Conditions
Keywords
Subthalamic nucleus, Globus pallidus, DBS
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.
Interventions
DEVICESIS System
FDA-cleared software that enhances standard clinical images for the visualization of structures in the basal ganglia area of the brain which are commonly targeted for DBS lead placement.
Sponsors
Surgical Information Sciences Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Euclidean distance (mm) between the planned target coordinate and actual implanted coordinate | 1 day | Compare the mean distance between the DBS planned target location to the actual implanted lead location for the SIS Group and Control Group |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 month | Compare surgical characteristics, such as rate of procedure-related adverse events, mean surgical time, and use of intra-operative testing for SIS and Control groups |
| 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) | 6 months | Compare DBS programming settings, such as therapeutic window of SIS and Control groups |
| Change in average levodopa equivalent daily dosage (mg) | 6 months | Compare change in mean levodopa equivalent daily dose for SIS and Control groups |
| Change in mean score of the Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III | 6 months | Compare changes in mean MDS-UPDRS Part III motor improvement for SIS and Control groups. MDS-UPDRS Part III is a validated questionnaire to assess the severity of motor symptoms in patients with Parkinson's disease. The motor examination consists of 33 scored movements. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score is obtained from the sum of the corresponding item scores. |
| Rate (%) of stimulation-related side effects | 6 months | Compare the rate of stimulation related side effects in SIS and Control groups |
| Compare percentage of motor benefit from MDS-UPDRS Part III to implanted lead location | 6 months | Measure hemi-body motor improvement and compare percentage of improvement to the implanted DBS lead location |
Countries
United States
Outcome results
None listed