Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2026-01-15
2031-01-15
Brief Summary
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Detailed Description
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After recording LFP data, then, the physician will perform the traditional clinical monopolar review and determine the optimized DBS settings ('clinician-based' settings) following standard clinical procedures, and without looking at the physiology data. In parallel, the LFP data will be analyzed to identify the 'optimal' therapy contact based on 1) maximum beta power, and 2 ) broad-band multi-frequency analysis.
The physician will then setup up to 4 stimulation programs will be set up:
1. Clinician-based programming (standard of care),
2. Maximum Beta power-based programming,
3. Broad-band programming.
4. If needed, second-best clinician-based programming (standard of care)
In this study, settings 1, 2, and 4 (optional) are determined based on established standards of care or manufacturer guidelines. Setting 3, however, is derived using our novel electrophysiology-based algorithm. While the method for determining this setting is innovative, the resulting parameter may be identical to those obtained through conventional approaches (settings 1, 2, or 4). Therefore, although the methodology introduces a new process, the final settings remain within clinically accepted ranges and do not exceed standard clinician-based practices.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Clinician-based
Clinician-based DBS programming
Contacts, amplitude, pulse width, and frequency are chosen by the treating physician during a conventional monopolar review.
Maximum beta power-based
Maximum Beta power-based DBS programming
The contact that shows the strongest beta activity (13-30 Hz) in the local field potentials is selected for stimulation.
Broad-band
Broad-band electrophysiology-based DBS programming
A multi-frequency algorithm that integrates beta, theta/alpha, finely tuned gamma, and other relevant bands is used to identify the optimal contact.
Interventions
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Clinician-based DBS programming
Contacts, amplitude, pulse width, and frequency are chosen by the treating physician during a conventional monopolar review.
Maximum Beta power-based DBS programming
The contact that shows the strongest beta activity (13-30 Hz) in the local field potentials is selected for stimulation.
Broad-band electrophysiology-based DBS programming
A multi-frequency algorithm that integrates beta, theta/alpha, finely tuned gamma, and other relevant bands is used to identify the optimal contact.
Eligibility Criteria
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Inclusion Criteria
* DBS implantation with the Percept DBS device (Medtronic, USA) for the treatment of motor symptoms
* Ability to give informed consent for the study
* Willingness to do this study at the time of the initial programming session
* Age 21 to 89 years old
Exclusion Criteria
* Atypical Parkinsonism
* Any personality or mood symptoms that study personnel believe will interfere with the study requirements
21 Years
89 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Joshua Wong, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB202500821
Identifier Type: -
Identifier Source: org_study_id
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