Recruiting

Low Frequency Burst Stimulation

Sponsor:

University of Southern California

Code:

NCT05307055

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STN DBS - Theta Burst

STN DBS - Gamma

Study Details

Brief 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

Study ID

NCT05307055

Start date

Jan 11, 2022

Status verified date

Jun, 2025

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female patients who had previously undergone bilateral STN deep brain stimulation implantation
2. Age >18 years old
3. Stable medication regimen for at least 3 months.
4. Patient informed and able to give written consent
5. Able to comply with all testing, follow-ups and study appointments and protocols

Exclusion Criteria:

1. History of epilepsy or seizure
2. History of dementia
3. History of major substance abuse

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group A

double-blinded randomization into theta burst stimulation followed by baseline stimulation

experimental: Group B

double blinded randomization into baseline stimulation followed by theta burst stimulation

Interventions

STN DBS - Theta Burst

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

STN DBS - Gamma

Standard of care gamma stimulation with an existing device

Primary outcome measure

  • Evaluation of motor symptoms [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 15, Week 27 ]
  • Evaluation of executive functioning [ Time Frame: Baseline, Week 1, Week 2, Week 3, Week 15, Week 27 ]
  • Neuroimaging [ Time Frame: Baseline, Week 15, Week 27 ]

Central Contacts and Locations

Central contacts

Darrin Lee, MD PhD

9495220866darrin.lee@med.usc.edu

Wooseong Choi, BS

8474017335wooseong@usc.edu

Locations

University of Southern California Keck School of Medicine

Recruiting

Los Angeles, California, United States, 90033

Contacts

Darrin Lee

949-522-0866Darrin.Lee@med.usc.edu

Wooseong Choi

8474017335wooseong@usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Keywords

  • Deep Brain Stimulation

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 Southern California on 2025-06-11.