Parkinson Disease, Idiopathic
Conditions
Keywords
Deep Brain Stimulation, Parkinson Disease, adaptive Deep Brain Stimulation, aDBS, conventional Deep Brain Stimulation, cDBS
Brief summary
The goal of this prospective, multi-center, randomized, double-blind, crossover clinical trial is to evaluate the effectiveness and safety of adaptive DBS (aDBS) and conventional DBS (cDBS) delivered through the AlphaDBS system, in levodopa-responsive Parkinson's disease subjects. Data from previous studies conducted in Europe indicate that the use of the AlphaDBS system is safe and effective in both aDBS and cDBS modes. However, such studies suggest that aDBS may lead to more ON-time without troublesome dyskinesias in some patients. The study is designed to first demonstrate safety of effectiveness of cDBS, then to directly compare effectiveness of aDBS relative to cDBS. Subjects enrolled in the study will undergo multiple visits to assess the improvement of PD symptoms and will be randomized to Mode 1 for three months, followed by Mode 2. At the end of Mode 2, subjects will select their preferred mode, which will be maintained for 3 additional months. Subjects will complete patient diaries at different time points to evaluate their symptoms throughout the day.
Interventions
DEVICEDeep Brain Stimulation
AlphaDBS System
Sponsors
Newronika
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
It is a prospective, multi-center, randomized, double-blind, cross over clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical trial: 1. Is willing and capable of signing informed consent 2. Is ≥18 years old 3. Has been diagnosed with levodopa-responsive idiopathic Parkinson's disease 4. Has a Hoehn and Yahr (H\&Y) scale stage of II or III when OFF medication at screening 5. Exhibits motor fluctuations and PD-related symptoms that are not adequately controlled with medication, including motor complications of recent onset (\>4 months duration) 6. Has been referred for bilateral STN DBS in accordance with local practice 7. Must be a good surgical candidate for placement of a deep brain stimulator as judged by the DBS surgical team 8. Montreal Cognitive Assessment (MoCA) score of ≥ 26 at the Baseline/Screening visit (when in "MedsON" state) 9. UPDRS-III improvement by ≥30% with the levodopa challenge test as measured at approximately 90 minutes following administration of the challenge dose 10. ≥4 hours per day (waking hours) with poor motor symptoms control (time "OFF" plus time "ON" with dyskinesia) despite optimal medical therapy, as assessed by the 3-day diary (at preop baseline) 11. Subject successfully completed a test diary reaching a sufficient level of agreement (\>75%) with study personnel responses and is willing and capable of completing a 3-day diary at each of the time points required per the protocol 12. If female, subjects who are not currently pregnant as determined by negative serum pregnancy test, breastfeeding, or who are post-menopausal, surgically sterile or willing to use birth control for the duration of the study (acceptable forms of birth control are: hormone therapies (oral, injected, transdermal or implanted), IUD or other barrier methods (e.g., condom, diaphragm, cervical cap, spermicide/gel) or partner is surgically sterile 13. Subject maintained a constant anti-PD medication treatment (best medical management, as duly documented) for at least 2 weeks prior to Baseline assessments 14. Subject is willing and able to attend all study-required visits, complete the study procedures and attend appropriate follow up visits
Exclusion criteria
The subject must not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Good On Time (GOT) | After 3 months of follow up in cDBS as compared with preop baseline | Mean improvement in GOT with cDBS, when compared with preop baseline, measured at the end of Mode 1, as assessed by a 3-day Hauser diary. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GOT difference between aDBS and cDBS | 6 months of follow up (end of of the second crossover period) | The mean difference in GOT (aDBS - cDBS) at the end of the second crossover period |
| UPDRS III score difference between aDBS and cDBS | 6 months of follow up (end of of the second crossover period) | The mean difference in UPDRS III scores (aDBS - cDBS) at the end of the second crossover period |
| PDQ-39 score difference between aDBS and cDBS | 6 months of follow up (end of of the second crossover period) | The mean difference in PDQ-39 score (aDBS - cDBS) at the end of the second crossover period |
| Subject Preference for aDBS vs. cDBS | 6 months of follow up (end of of the second crossover period) | The proportion of subjects that prefer adaptive (aDBS) mode over conventional (cDBS)mode, according to subject preference selection |
Outcome results
None listed