Parkinson Disease (PD)
Conditions
Keywords
Parkinson Disease, DBS leads, Boston Scientific Vercise DBS system, Cartesia directional leads, Anodic, Cathodic
Brief summary
Randomized, double-blind, crossover design, interventional study to assess the differences between mixed cathodic/anodic, pure cathodic, and pure anodic stimulation with respect to efficacy, side effect thresholds, symptom control, and quality of life in Parkinson's Disease patients implanted with Boston Scientific Cartesia directional DBS leads in the bilateral STN.
Detailed description
Prior studies and literature have suggested that directional leads might enable the use of complex bipolar configurations to activate neurons within a target and avoid side effects based on knowledge of local fiber tracts. The Boston Scientific Vercise system offers a unique opportunity to test this hypothesis. The Cartesia lead is a directional lead with 4 levels of contact, the middle 2 which are segmented, while the Vercise Genus generators utilize multiple independent current sources connected to each contact. This combination enables complex, highly customizable stimulation configurations, which can be incrementally adjusted in real time, without recourse to shutting the device off between parameter changes. This study proposes to utilize this technology to compare pure cathodic, pure anodic, and mixed cathodic/anodic stimulation in patients with Parkinson's Disease implanted with STN-DBS leads. The primary objective is to assess the differences between mixed cathodic/anodic, pure cathodic, and pure anodic stimulation with respect to efficacy, side effect thresholds, minimum current amplitude that activates side effects inducing the pyramidal tract, symptom control, and quality of life in Parkinson's Disease (PD) patients implanted with Boston Scientific Cartesia directional DBS leads in the bilateral STN.
Interventions
DEVICEMixed Cathodic/Anodic
Mixed cathodic/anodic stimulation setting on the Boston Scientific Vercise DBS system.
DEVICEPure Cathodic
Pure cathodic stimulation setting on the Boston Scientific Vercise DBS system.
DEVICEPure Anodic
Pure anodic stimulation setting on the Boston Scientific Vercise DBS system.
Sponsors
University of South Florida
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized, double-blind, crossover design, interventional study.
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients that are between the ages of 40-80 years of age. * Patients diagnosed with Idiopathic Parkinson's Disease that are treated with bilateral STN DBS Boston Scientific Vercise Cartesia directional leads for at least 3 months. * Patients whose DBS settings can be optimized to include anodic and cathodic stimulation.
Exclusion criteria
* Parkinson's Disease patients implanted with DBS leads outside of FDA labeling. * Patients who are not chronically using anodic stimulation parameters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parkinson's Disease Questionnaire-39 (PDQ-39) | At the end of patient's participation in the study, 3 months. | Patient's preferred stimulation parameter setting (with or without anodic stimulation) determined by their responses to the questionnaire and patient's stated preference. The score ranges from 0-100, with lower scores reflecting better quality of life of patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Scores | Baseline and 4 weeks after each parameter setting. | Change in UPDRS part III motor scores obtained ON stimulation/OFF medications at 4 weeks on each parameter setting relative to UPDRS part III motor scores obtained OFF stimulation/OFF medications at baseline. Scores range from 0-132. 0 indicates no motor impairment, 32 or below is considered mild impairment, and a score of 59 and above indicates severe impairment. |
| Unified Parkinson's Disease Rating Scale (UPDRS) Part III Motor Sub-scores | Baseline and 4 weeks after each parameter setting. | Change in UPDRS part III motor sub-scores (tremor, rigidity, bradykinesia, postural stability/gait) obtained ON stimulation/OFF medications at 4 weeks on each parameter setting relative to UPDRS part III motor scores obtained OFF stimulation/OFF medications at baseline. 8 sub-scores for each section of the scale. Each sub-section is scored from 0-4, or a score of 8 if "untestable". A score of 0 in each sub-section or a lower score normal or absence of symptom. |
| Clinical Global Impression- Positive Symptoms (CGI-P) Scores Mixed Cathodic/Anodic | 4 weeks following mixed cathodic/anodic stimulation. | CGI-P at 4 weeks following mixed cathodic/anodic stimulation. The scale uses a 7-point severity scale with 1 indicating normal or no positive symptoms and 7 indicating most severely ill patients with positive symptoms. Each item is rated independently on the 7-point scale. |
| Clinical Global Impression- Positive Symptoms (CGI-P) Scores Pure Cathodic | 4 weeks following pure cathodic stimulation. | CGI-P scores at 4 weeks following pure cathodic stimulation. The scale uses a 7-point severity scale with 1 indicating normal or no positive symptoms and 7 indicating most severely ill patients with positive symptoms. Each item is rated independently on the 7-point scale. |
| Clinical Global Impression- Positive Symptoms (CGI-P) Scores Pure Anodic | 4 weeks following pure anodic stimulation. | CGI-P scores at 4 weeks following pure anodic stimulation. The scale uses a 7-point severity scale with 1 indicating normal or no positive symptoms and 7 indicating most severely ill patients with positive symptoms. Each item is rated independently on the 7-point scale. |
| Patient Global Impression of Change (PGI-C) Scores Mixed Cathodic/Anodic | 4 weeks following mixed cathodic/anodic stimulation. | PGI-C scores at 4 weeks following mixed cathodic/anodic stimulation. The scale uses a 7-point Likert scale for scoring. Scores of 1 and 2 indicate significant improvement, score of 4 indicates no change in patient's status, and scores of 5 or higher indicate worsening or deteriorating changes in patient. |
| Patient Global Impression of Change (PGI-C) Scores Pure Cathodic | 4 weeks following pure cathodic stimulation. | PGI-C scores at 4 weeks following pure cathodic stimulation. The scale uses a 7-point Likert scale for scoring. Scores of 1 and 2 indicate significant improvement, score of 4 indicates no change in patient's status, and scores of 5 or higher indicate worsening or deteriorating changes in patient. |
| Patient Global Impression of Change (PGI-C) Scores Pure Anodic | 4 weeks following pure anodic stimulation. | PGI-C scores at 4 weeks following pure anodic stimulation. The scale uses a 7-point Likert scale for scoring. Scores of 1 and 2 indicate significant improvement, score of 4 indicates no change in patient's status, and scores of 5 or higher indicate worsening or deteriorating changes in patient. |
| Threshold for Clinical Benefit During Deep Brain Stimulation Programming | Throughout the patient's participation in the study, 3 months. | Minimum stimulation amplitude required to achieve a predefined clinical benefit at each stimulation parameter setting, including mixed cathodic/anodic stimulation, pure cathodic stimulation, and pure anodic stimulation. Clinical benefit will be determined based on investigator assessment of motor symptom improvement during stimulation programming. The unit of measure is "Stimulation amplitude (mA)". |
| Threshold for Stimulation-Related Adverse Effects During Deep Brain Stimulation Programming | Throughout the patient's participation in the study, 3 months. | Minimum stimulation amplitude at which a stimulation-related adverse effect is first observed or reported during programming at each stimulation parameter setting, including mixed cathodic/anodic stimulation, pure cathodic stimulation, and pure anodic stimulation. Adverse effects will be identified through participant report and investigator assessment during systematic amplitude titration. Unit of Measure: "Stimulation amplitude (mA)". |
| Model of the Volume of Tissue Activated (VTA) | Baseline and 4 weeks after each parameter setting. | Model of the VTA resulting from each stimulation parameter setting compared with respect to the regional anatomy as derived from patient-specific segmentation of pre-operative MRI and post-operative/post-enrollment CT studies. Relative location, extent, and spread out of the boundaries of the Subthalamic Nucleus (STN) of VTAs obtained with all stimulation parameter settings. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYarema Bezchlibnyk
University of South Florida
Outcome results
None listed