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NCT Number: NCT07348705

Electrophysiology-based DBS Programming for PD

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.

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Key information

Age range

21 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

Location status: Recruiting

Location contact

Hikaru Kamo, MD, PhD

CONTACT

[email protected]

Hikaru Kamo, MD, PhD

SUB_INVESTIGATOR

Joshua Wong, MD

PRINCIPAL_INVESTIGATOR

Julia C Gonzalez, BA

CONTACT

[email protected]

About this study

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:

  • Clinician-based programming (standard of care),
  • Maximum Beta power-based programming,
  • Broad-band programming.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinician-based DBS programming

Device

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

Maximum Beta power-based DBS programming

Device

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

Device

A multi-frequency algorithm that integrates beta, theta/alpha, finely tuned gamma, and other relevant bands is used to identify the optimal contact.

Primary outcomes

  1. Assessment of motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: From enrollment to end of study (1 month)

    The UPDRS (Unified Parkinson's Disease Rating Scale) Motor Scale (Part III) is a clinician-rated tool assessing motor functions like tremor, rigidity, bradykinesia, and gait in Parkinson's disease (PD), using a 0-4 scale for each item, with higher scores indicating greater impairment, helping track disease progression and treatment response.

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Wong, MD

CONTACT

[email protected]

352-294-5400

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Electrophysiology-based Deep Brain Stimulation Programming for Parkinson's Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2031
First posted
Jan 16, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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