Electrophysiology-based DBS Programming for PD

NCT ID: NCT07348705

Last Updated: 2026-01-16

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-15

Study Completion Date

2031-01-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson's Disease (PD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Clinician-based

Group Type ACTIVE_COMPARATOR

Clinician-based DBS programming

Intervention Type DEVICE

Contacts, amplitude, pulse width, and frequency are chosen by the treating physician during a conventional monopolar review.

Maximum beta power-based

Group Type ACTIVE_COMPARATOR

Maximum Beta power-based DBS programming

Intervention Type DEVICE

The contact that shows the strongest beta activity (13-30 Hz) in the local field potentials is selected for stimulation.

Broad-band

Group Type EXPERIMENTAL

Broad-band electrophysiology-based DBS programming

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Joshua Wong, MD

Role: CONTACT

352-294-5400

Facility Contacts

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Hikaru Kamo, MD, PhD

Role: primary

Julia C Gonzalez, BA

Role: backup

Other Identifiers

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IRB202500821

Identifier Type: -

Identifier Source: org_study_id

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