Electrophysiology-based DBS Programming for PD

University of Florida

Status: Enrolling

Conditions: Parkinson's Disease (PD)

Treatments: Device: Broad-band electrophysiology-based DBS programming; Device: Maximum Beta power-based DBS programming; Device: Clinician-based DBS programming

Study type: Interventional

Funder types: Other

Identifiers

NCT07348705

IRB202500821

Details and patient eligibility

About

Deep brain stimulation (DBS) effectively alleviates motor symptoms in Parkinson's disease (PD). However, current programming is manual and time-consuming. This study will evaluate physiology-based programming using local field potentials (LFPs) to identify optimal stimulation parameters. Specifically, DBS contact selection based on beta power and a broad-band approach will be compared with conventional clinician-based programming.

Full description

Up to thirty patients with DBS (unilateral or bilateral leads) attached to a bidirectional implantable pulse generator will be enrolled in this study. This commercially available IPG allows both therapeutic stimulation and chronic sensing. It has been designed to capture local field potentials (LFPs) from implanted DBS leads while delivering stimulation both inside and outside the clinic.

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis of idiopathic PD fulfilling the Movement Disorder Society Clinical Diagnostic Criteria for PD
• 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

• Inability to comply with the study protocol
• Atypical Parkinsonism
• Any personality or mood symptoms that study personnel believe will interfere with the study requirements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 3 patient groups

Clinician-based

Active Comparator group

Treatment:

Device: Clinician-based DBS programming

Maximum beta power-based

Active Comparator group

Treatment:

Device: Maximum Beta power-based DBS programming

Broad-band

Experimental group

Treatment:

Device: Broad-band electrophysiology-based DBS programming