Recruiting

DBS vs. Programming

Sponsor:

University of Florida

Code:

NCT07348705

Conditions

Parkinson's Disease (PD)

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Clinician-based DBS programming

Maximum Beta power-based DBS programming

Broad-band electrophysiology-based DBS programming

Study Details

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)

Study ID

NCT07348705

Start date

Jan 15, 2026

Status verified date

Jan, 2026

Completion date

Jan 15, 2031

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Clinician-based

active comparator: Maximum beta power-based

experimental: Broad-band

Interventions

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.

Primary outcome measure

  • Assessment of motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: From enrollment to end of study (1 month) ]

Central Contacts and Locations

Central contacts

Joshua Wong, MD

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

Locations

Norman Fixel Institute for Neurological Diseases

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Hikaru Kamo, MD, PhD

Hikaru.Kamo@neurology.ufl.edu

Julia C Gonzalez, BA

Julia.Gonzalez@neurology.ufl.edu

Principal Investigator:

Joshua Wong, MD

More Information

Sponsor

University of Florida

Last update posted

Mar 30, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-03-30.