Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05307055

Evaluation of Neurocognitive Changes in Parkinson's Disease After Low Frequency Burst Stimulation

Led by University of Southern California · Updated on 2025-06-11

40

Participants Needed

1

Research Sites

398 weeks

Total Duration

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AI-Summary

What this Trial Is About

This study aims to determine whether direct brain stimulation of specific regions and ranges improves cognition in people with Parkinsons Disease (PD) who already have a deep brain stimulator implanted. Research activities consist of 32 subjects undergoing stimulation changes to their device and being administered neurocognitive tests to evaluate the changes. An fMRI scan will also be done at baseline and at weeks 15 and 27. All subjects will undergo the stimulation changes in a randomized double blind crossover study. Evaluation of stimulation changes will be assessed through analysis of neurocognitive data.

CONDITIONS

Official Title

Evaluation of Neurocognitive Changes in Parkinson's Disease After Low Frequency Burst Stimulation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients who had previously undergone bilateral STN deep brain stimulation implantation
  • Age >18 years old
  • Stable medication regimen for at least 3 months
  • Patient informed and able to give written consent
  • Able to comply with all testing, follow-ups and study appointments and protocols
Not Eligible

You will not qualify if you...

  • History of epilepsy or seizure
  • History of dementia
  • History of major substance abuse

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Southern California Keck School of Medicine

Los Angeles, California, United States, 90033

Actively Recruiting

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Research Team

D

Darrin Lee, MD PhD

CONTACT

W

Wooseong Choi, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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