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NCT Number: NCT05307055

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

In this single-center pilot study, the investigators will study both acute and chronic changes to neurocognitive and motor performance in response to interleaving gamma/theta (theta burst) stimulation compared to standard-of-care gamma stimulation.

This study will be a randomized double-blinded crossover study. Each patient's baseline voltage intensity will be unchanged. During the first outpatient visit, a baseline assessment (under baseline stimulation parameters, including frequency, pulse width and voltage) consisting of motor and cognitive tests will first be performed. After one week of titration on the theta burst stimulation paradigm, all patients will randomized to either baseline or theta burst stimulation settings for one week. Motor testing (UPDRS) and neuropsychological testing will be performed after this week. Each patient will then be programmed to the other stimulation paradigm for another week. At the end of this third week, neuropsychological and motor testing will again be performed.

Patients will again be randomized into either baseline gamma stimulation or theta burst stimulation for the chronic phase of the study. Repeat neuropsychological and motor testing will be performed at three months. Each patient will switched to the other stimulation strategy and repeat neuropsychological and motor testing will be performed after another three months. After the first 6 months, patients will be placed on open-label theta burst stimulation for 6 months (total of one year). At the end of one year, patients will undergo repeat neuropsychological and motor testing, after which they will be reprogrammed to their initial settings or given the option to remain on theta burst stimulation parameters. Functional magnetic resonance imaging will be acquired during baseline, week 15, and week 27 visits for patients with compatible devices that meet the inclusion criteria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

STN DBS - Theta Burst

Device

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

STN DBS - Gamma

Device

Standard of care gamma stimulation with an existing device

Primary outcomes

  1. Evaluation of motor symptoms

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 15, Week 27

    Effects of theta burst stimulation on changes in baseline motor symptoms will be assessed using the MDS-Unified Parkinson's Disease Rating Scale - Sections III&IV (MDS-UPDRS III&IV)

  2. Evaluation of executive functioning

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 15, Week 27

    Effects of theta burst stimulation on changes in baseline cognitive symptoms will be assessed using Delis-Kaplan Executive Function System (D-KEFS).

  3. Neuroimaging

    Time frame: Baseline, Week 15, Week 27

    Effects of theta burst stimulation on changes in baseline resting state functional connectivity will be assessed using functional magnetic resonance imaging.

Study contacts

Contact information is provided by the study sponsor or research team.

Darrin Lee, MD PhD

CONTACT

[email protected]

9495220866

Wooseong Choi, BS

CONTACT

[email protected]

8474017335

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Theta Burst Subthalamic Nucleus Deep Brain Stimulation for Cognitive and Motor Improvements in Parkinson's Disease

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Apr 1, 2022
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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