Parkinson Disease
Conditions
Brief summary
The aim of this study is to assess the safety and the potential efficacy of personalized Local Field Potential (LFP)-based adaptive Deep Brain Stimulation (aDBS), using the implantable pulse generator (IPG) of the AlphaDBS System, in Parkinson's Disease patients, chronically implanted in subthalamic nucleus (STN) for DBS.
Detailed description
The study protocol is organized in two phases: the short-term follow-up and the long-term follow-up. PD patients in need of IPG replacement or de novo DBS patients will be screened for enrollment eligibility. For the short-term follow-up, randomized patients will undergo 2 days of experimental sessions (i.e. one per each type of stimulation mode, cDBS and aDBS), in a well-controlled environment (i.e. during hospitalization). This part of the study will collect information on safety and potential efficacy endpoints as assessed by experienced neurologists. The short term follow-up phase will be considered complete when the endpoint assessment has been performed for all patients. Patients, who will not experience severe side effects and who will be deemed suitable by the neurologist, will be eligible to continue in the long-term follow-up phase (i.e. 1 month) in their home environment. The AlphaDBS System will deliver the stimulation in aDBS or cDBS mode, for two weeks in each mode.
Interventions
DEVICEAlphaDBS System
AlphaDBS can be programmed with two different types of stimulation: conventional DBS and adaptive DBS, that automatically adjusts the energy delivered to patient using a biosignal, local field potential (LFP), in a close loop configuration.
Sponsors
Newronika
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
IPG Replacement Patients: Inclusion Criteria 1. Diagnosis of idiopathic PD; 2. Subject is bilaterally treated with DBS in the STN using a Medtronic Activa PC or Activa RC IPG (mono-channnel or dual channel); 3. DBS implant for at least 3 years and in need of battery replacement within 12 months after consent; 4. Patients must be able to understand and sign the informed consent document.
Exclusion criteria
1. Patients with severe cognitive decline, as resulting from MoCA assessment (MoCA score \< 10); 2. Patients with major psychiatric issues or any other condition that, based on the physician opinion, could interfere with the study conduct (e.g. severe depression, psychosis, etc.); 3. Patients with any medical conditions potentially interfering with DBS battery replacement surgery (e.g. severe hypertension, active cancer, intake of drugs interfering with the coagulation etc.); 4. Need to replace or reposition the leads during the IPG replacement procedure; 5. Patients with \> 10 recurrent falls experienced in the 3 months prior to consent; 6. Patients that cannot tolerate an interruption of DBS stimulation for at least 30 min; 7. Patients taking less than one levodopa dose per day; 8. Patients without suitable LFPs recordings or with significant artifacts; 9. Pregnant or breastfeeding women. De Novo DBS Patients: Inclusion Criteria 1. Patient is ≥ 18 years old; 2. Patient has been diagnosed with levodopa-responsive idiopathic Parkinson's disease for ≥ 5 years; 3. The disease stage is II, III or IV according to the Hoehn and Yahr scale 4. Patient has history of improvement of PD-related symptoms as a direct result of levodopa intake; 5. Patient has been selected for bilateral STN or GPi DBS, independently from this study, in accordance with local standard of care DBS screening; 6. Patient has been selected to receive Medtronic leads model 3389 or 37086 or Abbott directional leads model number 6170 or 6172 or 6371, independently from this study, in accordance with local standard of care for DBS; 7. Patient has DBS-leads circuit integrity assessed and confirmed by impedance testing, before IPG implantation; 8. MoCA score \> 26 in best medical condition; 9. BDI-II score \< 17 in best medical condition; 10. UPDRS-III improvement by ≥ 33% with levodopa challenge test (at approximately 90 min from the intake of the usual morning levodopa dose plus 30%); 11. Patient is able to understand the study requirements and the treatment procedures and has provided written informed consent to participate; 12. Patient has a responsible caregiver who will help completing the 3-day diary, provide feedback on activities of daily living (ADL), and ensure the patient complies with visit schedule; 13. Patient is on stable PD-medication for one month prior surgery; 14. Patient is willing and able to attend all study-required visits, complete the study procedures and attend appropriate follow up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability of the AlphaDBS System, when used in cDBS and aDBS mode | 1 month | Occurrence of device related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyskinesia | 1 month | Evaluation of dyskinesia and their fluctuations through repeated clinical assessments using the Unified Dyskinesia Rating Scale - UDysRS |
| Time on with and without dyskinesia | 1 month | Evaluation of time on with and without dyskinesia, assessed through Patient Diary |
| Time off | 1 month | Evaluation of time off, assessed through Patient Diary |
| PD-related motor symptoms and their fluctuations | 1 month | Evaluation of PD-related motor symptoms using the Unified Parkinson's Disease Rating Scale - UPDRS Part III. |
| Usability of the system for the physician | 1 month | Usability will be evaluated by means of a usability questionnaire |
| Change in the TEED to the patient | 1 month | Change in the Total Electrical Energy Delivered (TEED) to the patient |
| Patient controller usability | 1 month | Usability will be evaluated by means of a usability questionnaire |
Countries
Italy, Netherlands, Poland
Contacts
Primary ContactCostanza Conti, PhD
Outcome results
None listed