Recruiting

pDBS

Sponsor:

University of Florida

Code:

NCT07410598

Conditions

Parkinson Disease

Deep Brain Stimulation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Biphasic deep brain stimulation

Conventional deep brain stimulation

Theta burst deep brain stimulation

Multi frequency deep brain stimulation

Study Details

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.

Conditions

Parkinson Disease

Deep Brain Stimulation

Study ID

NCT07410598

Start date

May 6, 2026

Status verified date

Jul, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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

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.

Interventions

Biphasic 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

Conventional deep brain stimulation programming that is currently FDA approved

Theta 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

Multi 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

Primary outcome measure

  • Tolerability of patterned DBS [ Time Frame: From enrollment to the end of novel waveform trial period at 2 weeks ]

Central Contacts and Locations

Central contacts

Joshua Wong, MD

352-294-5400joshua.wong@neurology.ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Joshua Wong, MD

352-294-5400joshua.wong@neurology.ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Parkinson disease
  • PD
  • DBS
  • deep brain stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-06.