Electrophysiology-based DBS Programming for PD

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07348705
Status
Recruiting

Conditions

  • Parkinson's Disease (PD)

Eligibility Criteria

Sex
ALL
Age
21 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Jan 2026
Primary completion
Jan 15, 2027
Completion
Jan 15, 2031

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Clinician-based
  • Active Comparator: Maximum beta power-based
  • Experimental: Broad-band

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

Locations (1)

FacilityCityStateZIPSite coordinators
Norman Fixel Institute for Neurological DiseasesGainesvilleFlorida32608
Hikaru Kamo, MD, PhD
Julia C Gonzalez, BA
Joshua Wong, MD (PRINCIPAL_INVESTIGATOR)
Hikaru Kamo, MD, PhD (SUB_INVESTIGATOR)

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