Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started May 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2026
CompletedFirst Posted
Study publicly available on registry
February 13, 2026
CompletedStudy Start
First participant enrolled
May 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
May 6, 2026
February 1, 2026
1.8 years
February 6, 2026
May 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tolerability of patterned DBS
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 Outcomes (2)
Change in motor symptom severity
From enrollment to the end of study period at 4 weeks
Change in quality of life
From enrollment to the end of the study period at 4 weeks
Study Arms (3)
Biphasic DBS (bDBS)
EXPERIMENTALFor participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing.
Nocturnal Theta Burst Stimulation (tDBS)
EXPERIMENTALIn 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
Region-Specific Frequency Alternation (fDBS)
EXPERIMENTALFor 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.
Interventions
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
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Floridalead
- Boston Scientific Corporationcollaborator
Study Sites (1)
University of Florida
Gainesville, Florida, 32608, United States
Related Publications (3)
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.
PMID: 32357269BACKGROUNDWong 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.
PMID: 33981207BACKGROUNDAkbar 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.
PMID: 27000764BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2026
First Posted
February 13, 2026
Study Start
May 6, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2028
Last Updated
May 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be shared upon publication
- Access Criteria
- Data will be shared as part of scientific publication
De-identified primary and secondary outcome data