Parkinson DiseaseNCT04715984
Corticostriatal Contributions to Parkinson's Disease Cognitive Impairment
A study testing Neurophysiology recordings and Neural stimulation in people with Parkinson Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The goal of this study is to learn more about the brain activity underlying Parkinson's disease cognitive impairment. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Neurophysiology recordings and Neural stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2021to 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center
- Planned clinical electrode trajectory that contacts caudate
- Age greater than or equal to 40
- Diagnosis of Parkinson's disease
- Able to participate in intraoperative testing
- English speaking
Who cannot join
- Age less than 40
- Not able to participate in intraoperative testing (for example unable to comprehend instructions or follow directions)
- Movement disorder other than Parkinson's disease
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
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Lucas Chang, BA, 615-421-3046, lucas.m.chang@vumc.org
Sarah Bick, MD
About this study
Official title: Corticostriatal Neurophysiology in Parkinson's Disease Cognitive Impairment
The goal of this study is to learn more about the brain activity underlying Parkinson's disease cognitive impairment. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease.
- Conditions
- Parkinson Disease
- Being tested
- Neurophysiology recordings, Neural stimulation
- 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.
Neurophysiology recordingsOther
Neurophysiology recordings will be performed during deep brain stimulation surgery and their relationship to performance on a gambling task evaluated
Neural stimulationOther
Neural stimulation will be delivered during a gambling task and its impact on task performance quantified
| Study group | Role | What they receive |
|---|---|---|
| Neural recordings and stimulation | Experimental | Not described Receives: Other: Neurophysiology recordings; Other: Neural stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in caudate DLPFC beta coherence
Caudate DLPFC coherence will be computed at rest and during the gambling task and correlated with cognitive metrics
Measured: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
Changes in gambling task performance with neural stimulation
The gambling task will involve seeing a series of cards presented on the screen and pressing a button to respond with a bet. Gambling task performance will be compared between stimulated and non stimulated blocks and between stimulation targets
Measured: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
Secondary outcomes (1)
Change in beta power with neural stimulation
Beta power will be computed and compared between stimulation on and off conditions for different targets
Measured: Baseline to end of deep brain stimulation (DBS) surgery, approximately 3-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start2 Jun 2021
- Primary completionAug 2029 (estimated)
- Study completionAug 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 Vanderbilt University Medical CenterThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Bick, Vanderbilt University Medical Center
- Investigators
- Sarah Bick, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715984
- Sponsor's protocol ID
- 201868
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticostriatal Neurophysiology in Parkinson's Disease Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04715984
- Acronym / sponsor ID
- 201868
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 20 Jan 2021 (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.
The goal of this study is to learn more about the brain activity underlying Parkinson's disease cognitive impairment. The investigators will utilize neural recordings from corticostriatal structures performed during deep brain stimulation surgery to measure neural activity underlying nonmotor symptoms of Parkinson's disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neural recordings and stimulation | Experimental | Other: Neurophysiology recordings, Other: Neural stimulation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center
- Planned clinical electrode trajectory that contacts caudate
- Age greater than or equal to 40
- Diagnosis of Parkinson's disease
- Able to participate in intraoperative testing
Key exclusion criteria (3 listed)
- Age less than 40
- Not able to participate in intraoperative testing (for example unable to comprehend instructions or follow directions)
- Movement disorder other than Parkinson's disease
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 |
|---|---|---|
| Neurophysiology recordingsNeurophysiology recordings will be performed during deep brain stimulation surgery and their relationship to performance on a gambling task evaluated | Other | Neural recordings and stimulation |
| Neural stimulationNeural stimulation will be delivered during a gambling task and its impact on task performance quantified | Other | Neural recordings and stimulation |
Primary outcome
Changes in caudate DLPFC beta coherence
Time frame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
Caudate DLPFC coherence will be computed at rest and during the gambling task and correlated with cognitive metrics
Changes in gambling task performance with neural stimulation
Time frame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
The gambling task will involve seeing a series of cards presented on the screen and pressing a button to respond with a bet. Gambling task performance will be compared between stimulated and non stimulated blocks and between stimulation targets
1 secondary outcome
Change in beta power with neural stimulation
Time frame: Baseline to end of deep brain stimulation (DBS) surgery, approximately 3-4 hours
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 12 Jun 2026.
- 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.
Sarah Bick, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurophysiology recordings and Neural stimulation in people with Parkinson Disease, run by Vanderbilt University Medical Center 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 6 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 12 Jun 2026. 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 Lucas Chang, BA (615-421-3046, lucas.m.chang@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in caudate DLPFC beta coherence (time frame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours). The study lists 2 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 12 Jun 2026.