Parkinson DiseaseNCT05307055
Evaluation of Neurocognitive Changes in Parkinson's Disease After Low Frequency Burst Stimulation
A study testing STN DBS - Theta Burst and STN DBS - Gamma in people with Parkinson Disease, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- STN DBS - Theta Burst and STN DBS - Gamma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2022to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of epilepsy or seizure
- History of dementia
- History of major substance abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California Keck School of Medicine
Los Angeles, California, 90033
Darrin Lee, 949-522-0866, Darrin.Lee@med.usc.edu
Wooseong Choi, 8474017335, wooseong@usc.edu
About this study
Official title: Theta Burst Subthalamic Nucleus Deep Brain Stimulation for Cognitive and Motor Improvements in Parkinson's Disease
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.
Read the detailed description
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.
- Conditions
- Parkinson Disease
- Being tested
- STN DBS - Theta Burst, STN DBS - Gamma
- Keywords
- Deep Brain Stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN DBS - Theta BurstDevice
200 Hz intraburst stimulation for 0.1 second repeated at intervals of 5hz with an existing device
STN DBS - GammaDevice
Standard of care gamma stimulation with an existing device
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | double-blinded randomization into theta burst stimulation followed by baseline stimulation Receives: Device: STN DBS - Theta Burst; Device: STN DBS - Gamma |
| Group B | Experimental | double blinded randomization into baseline stimulation followed by theta burst stimulation Receives: Device: STN DBS - Theta Burst; Device: STN DBS - Gamma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of motor symptoms
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)
Measured: Baseline, Week 1, Week 2, Week 3, Week 15, Week 27
Evaluation of executive functioning
Effects of theta burst stimulation on changes in baseline cognitive symptoms will be assessed using Delis-Kaplan Executive Function System (D-KEFS).
Measured: Baseline, Week 1, Week 2, Week 3, Week 15, Week 27
Neuroimaging
Effects of theta burst stimulation on changes in baseline resting state functional connectivity will be assessed using functional magnetic resonance imaging.
Measured: Baseline, Week 15, Week 27
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start11 Jan 2022
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darrin J Lee, MD, PhD, University of Southern California
- Investigators
- Darrin Lee, MD PhD, Principal investigator, University of Southern California, Keck School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307055
- Sponsor's protocol ID
- HS-20-00676
- Status last verified
- Jun 2025
- First submitted
- 14 Mar 2022
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theta Burst Subthalamic Nucleus Deep Brain Stimulation for Cognitive and Motor Improvements in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05307055
- Acronym / sponsor ID
- HS-20-00676
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: STN DBS - Theta Burst, Device: STN DBS - Gammadouble-blinded randomization into theta burst stimulation followed by baseline stimulation |
| Group B | Experimental | Device: STN DBS - Theta Burst, Device: STN DBS - Gammadouble blinded randomization into baseline stimulation followed by theta burst stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- History of epilepsy or seizure
- History of dementia
- History of major substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STN DBS - Theta Burst200 Hz intraburst stimulation for 0.1 second repeated at intervals of 5hz with an existing device | Device | Group A, Group B |
| STN DBS - GammaStandard of care gamma stimulation with an existing device | Device | Group A, Group B |
Primary outcome
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)
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).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darrin Lee, MD PhD principal investigator
University of Southern California, Keck School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STN DBS - Theta Burst and STN DBS - Gamma in people with Parkinson Disease, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darrin Lee, MD PhD (9495220866, darrin.lee@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of motor symptoms (time frame: Baseline, Week 1, Week 2, Week 3, Week 15, Week 27). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.