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

NCT05307055 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-11

No results posted yet for this study

Summary

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

  • Parkinson Disease

Interventions

DEVICE

STN DBS - Theta Burst

200 Hz intraburst stimulation for 0.1 second repeated at intervals of 5hz with an existing device

DEVICE

STN DBS - Gamma

Standard of care gamma stimulation with an existing device

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Darrin Lee, MD PhD · University of Southern California, Keck School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-11
Primary Completion
2029-08-31
Completion
2029-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05307055 on ClinicalTrials.gov