Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting
Study Overview
Status
Conditions
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:
- Biphasic DBS (bDBS)
- Nocturnal Theta Burst Stimulation (tDBS)
- 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joshua Wong, MD
- Phone Number: 352-294-5400
- Email: joshua.wong@neurology.ufl.edu
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32608
- Recruiting
- University of Florida
-
Contact:
- Joshua Wong, MD
- Phone Number: 352-294-5400
- Email: joshua.wong@neurology.ufl.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Biphasic DBS (bDBS)
For participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing.
|
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
|
|
Experimental: Nocturnal Theta Burst Stimulation (tDBS)
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
|
Conventional deep brain stimulation programming that is currently FDA approved
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
|
|
Experimental: Region-Specific Frequency Alternation (fDBS)
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.
|
Conventional deep brain stimulation programming that is currently FDA approved
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tolerability of patterned DBS
Time Frame: 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.
|
From enrollment to the end of novel waveform trial period at 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in motor symptom severity
Time Frame: 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
|
From enrollment to the end of study period at 4 weeks
|
|
Change in quality of life
Time Frame: 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
|
From enrollment to the end of the study period at 4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Horn MA, Gulberti A, Gulke E, Buhmann C, Gerloff C, Moll CKE, Hamel W, Volkmann J, Potter-Nerger M. A New Stimulation Mode for Deep Brain Stimulation in Parkinson's Disease: Theta Burst Stimulation. Mov Disord. 2020 Aug;35(8):1471-1475. doi: 10.1002/mds.28083. Epub 2020 May 1.
- Wong JK, Hu W, Barmore R, Lopes J, Moore K, Legacy J, Tahafchi P, Jackson Z, Judy JW, Raike RS, Wang A, Tsuboi T, Okun MS, Almeida L. Safety and Tolerability of Burst-Cycling Deep Brain Stimulation for Freezing of Gait in Parkinson's Disease. Front Hum Neurosci. 2021 Apr 26;15:651168. doi: 10.3389/fnhum.2021.651168. eCollection 2021.
- Akbar U, Raike RS, Hack N, Hess CW, Skinner J, Martinez-Ramirez D, DeJesus S, Okun MS. Randomized, Blinded Pilot Testing of Nonconventional Stimulation Patterns and Shapes in Parkinson's Disease and Essential Tremor: Evidence for Further Evaluating Narrow and Biphasic Pulses. Neuromodulation. 2016 Jun;19(4):343-56. doi: 10.1111/ner.12397. Epub 2016 Mar 22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202501673
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.