Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07410598
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Biphasic deep brain stimulation — DEVICE
    Deep brain stimulation using active recharge biphasic waveforms consisting of an equal anodic and cathodic pulse immediately delivered sequentially
  • Conventional deep brain stimulation — DEVICE
    Conventional deep brain stimulation programming that is currently FDA approved
  • Theta burst deep brain stimulation — DEVICE
    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 — DEVICE
    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

Study Details

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.

Key Dates

Start date
May 6, 2026
Status verified
Feb 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32608
Joshua Wong, MD
[email protected]
352-294-5400

Find similar trials in Gainesville, FL

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Florida· Gainesville, FL

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