Electrophysiology-based DBS Programming for PD

NCT07348705 | Recruiting FDA Device

• 1 other identifier: IRB202500821
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease (PD)

Keywords

deep brain stimulation; DBS; PD; Parkinson's disease; beta power

Outcome Measures

Primary Outcomes (1)

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

  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.

  From enrollment to end of study (1 month)

Study Arms (3)

Clinician-based

ACTIVE COMPARATOR

Device: Clinician-based DBS programming

Maximum beta power-based

ACTIVE COMPARATOR

Device: Maximum Beta power-based DBS programming

Broad-band

EXPERIMENTAL

Device: Broad-band electrophysiology-based DBS programming

Interventions

Clinician-based DBS programming DEVICE

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

Clinician-based

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.

Maximum beta power-based

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.

Broad-band

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Joshua Wong, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Wong, MD

CONTACT

352-294-5400; Joshua.Wong@neurology.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 16, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2031
• Last Updated: March 30, 2026

Record last verified: 2026-01

Locations

US (1)