Deep Brain Stimulation, Parkinson Disease
Conditions
Keywords
Parkinson disease, PD, DBS, deep brain stimulation
Brief summary
The primary objective of the proposed pilot study is to assess the safety and tolerability of active patterned Deep Brain Stimulation (pDBS) when administered in a home setting for patients with Parkinson's disease (PD) who have had stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS.
Detailed description
This pilot study will investigate the safety, tolerability, and feasibility of three distinct patterned Deep Brain Stimulation (pDBS) paradigms delivered in a home setting using the Boston Scientific Chronos Research Engine. The three stimulation patterns under evaluation are: 1. Biphasic DBS (bDBS) 2. Nocturnal Theta Burst Stimulation (tDBS) 3. Region-Specific Frequency Alternation (fDBS). Sixty patients with Parkinson's Disease (PD), each with stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS for at least six months, will be enrolled and assigned to one of the three parallel study arms. At the baseline visit, each participant will be programmed with two stimulation settings: one replicating their chronic best clinical setting, and a second incorporating the assigned patterned stimulation. For participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing. In the tDBS arm, the second setting will deliver theta burst stimulation-six bursts per second at the therapeutic frequency-during nighttime hours, using the internal IPG clock to align with the participant's typical sleep schedule. For those in the fDBS arm, the second setting will apply high-frequency stimulation to dorsal contacts (Levels 3 or 4) and low-frequency stimulation (30-60 Hz) to ventral contacts (Levels 1 or 2), while maintaining all other clinical parameters. Participants will be blinded to the identity of the two settings and will be able to switch between them using their patient programmer. The study will follow a randomized, blinded, two-period crossover design over a total duration of four weeks. During the first two weeks, participants will use one of the two programmed settings. At the end of this period, a telemedicine visit will be conducted to collect quality of life (QoL) questionnaires, related surveys, and a video-based modified MDS-UPDRS assessment. Participants will then switch to the alternate setting for the remaining two weeks. At the conclusion of the study, participants will return for an in-person research visit to complete the same assessments for the second setting. This design allows for within-subject comparison of conventional DBS and patterned DBS in a real-world, home-based environment, and will generate critical data to inform the design of a future large-scale trial.
Interventions
DEVICEBiphasic deep brain stimulation
Deep brain stimulation using active recharge biphasic waveforms consisting of an equal anodic and cathodic pulse immediately delivered sequentially
Conventional deep brain stimulation programming that is currently FDA approved
DEVICETheta burst deep brain stimulation
Deep brain stimulation using a conventional waveform but timed such that in the evening hours (based on device clock) the device will adjust stimulation to bursts of conventional stimulation at 6 per second
DEVICEMulti frequency deep brain stimulation
Deep brain stimulation using conventional waveforms but simultaneously delivering high frequency stimulation on the dorsal contacts of the DBS lead and low frequency stimulation on the ventral contacts of the DBS lead
Sponsors
University of Florida
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Bilateral STN or GPi DBS with Boston Scientific Vercise Genus DBS System * Diagnosis of Parkinson's disease as confirmed by a movement disorders fellowship trained neurologist * Chronic stable DBS therapy, defined as having DBS therapy for at least 6 months
Exclusion criteria
* History of previous neurosurgical intervention aside from DBS * Diagnosis of dementia (whether primary or related to Parkinson's disease) * A diagnosis of atypical parkinsonism or secondary parkinsonism at any time after DBS implantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability of patterned DBS | From enrollment to the end of novel waveform trial period at 2 weeks | The primary endpoint of this study is the proportion of participants who are able to tolerate patterned DBS (pDBS) for the full two-week intervention period. Tolerability is defined as the ability to remain on the assigned pDBS setting without reverting to an alternative DBS configuration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in motor symptom severity | From enrollment to the end of study period at 4 weeks | A comparison of the modified MDS-UPDRS between conventional and patterned waveform based on a video assessment |
| Change in quality of life | From enrollment to the end of the study period at 4 weeks | A comparison of quality of life metrics through the Parkinson's Disease Questionnaire (PDQ-39) between conventional and patterned DBS |
Countries
United States
Contacts
CONTACTJoshua Wong, MD
Outcome results
None listed