Deep Brain StimulationNCT06960096
Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study
An observational study of Deep Brain Stimulation and Parkinson Disease, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The objective of this research study is to understand how Deep Brain Stimulation (DBS) targeting the subthalamic nucleus (STN) affects cognitive networks in the brain, potentially leading to cognitive decline in patients with Parkinson's Disease (PD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deep Brain Stimulation, Parkinson Disease
- What is being tested?
- DBS combined with fMRI
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2025to 1 Apr 2028
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will enroll individuals with Parkinson's disease who are undergoing clinically indicated subthalamic nucleus deep brain stimulation (STN-DBS). Participants will complete pre-operative neuroimaging using diffusion and structural MRI sequences, as well as standardized neurocognitive assessments. One year following DBS, participants will complete a follow-up cognitive evaluation. The goal is to identify brain microstructural features that predict cognitive decline after DBS.
Who may be able to join
- Subjects above 18 years of age
- Individuals with a PD diagnosis as defined by the UK Brain Bank diagnostic criteria for Parkinson's disease (58) which have undergone a neurological and neuropsychological evaluation at MUSCs movement disorder center, and were selected to undergo 3T compatible unilateral or bilateral STN- DBS implants
Who cannot join
- Uncorrected visual or hearing impairments, as indicated by self-report
- Individuals who are pregnant or expect to become pregnant during the course of the study
- Individuals that have a history of neurological disease (other than PD) including previous stroke, major head trauma, and epilepsy or seizures.
- Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner
- COPD with oxygen dependence
- Non-MRI compatible metal implants (surgical clips or staples, cardiac pacemakers etc.)
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
Medical University of South Carolina
Charleston, South Carolina, 29425
Daniel H. Lench, Phd, 843-792-9115, lenchd@musc.edu
About this study
Official title: A Neural Basis for Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study
The objective of this research study is to understand how Deep Brain Stimulation (DBS) targeting the subthalamic nucleus (STN) affects cognitive networks in the brain, potentially leading to cognitive decline in patients with Parkinson's Disease (PD). A total of 55 participants with PD who have undergone DBS surgery will be recruited from MUSC's Clinical DBS Program. Participants will attend two post-DBS visits: a 3-hour visit for consent, demographic, and cognitive assessments, and a 3-hour DBS-MRI visit to evaluate brain network connectivity with stimulation ON and OFF. These findings will help improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.
Read the detailed description
Deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) is a well-established surgical intervention to treat Parkinson's Disease (PD) patients with disabling motor fluctuations and dyskinesias. Although this therapy is effective for motor complications, a subset of patients will go on to experience cognitive decline, which can overshadow improvements in the quality of life provided by STN-DBS. This accelerated decline in cognition occurs in patients despite rigorous evaluation of their neuropsychological status prior to surgery. While the factors contributing to cognitive decline following DBS remain unclear, there is evidence this may be the result of 1) limited cognitive reserve prior to DBS surgery, 2) stimulation that interferes with cognitive networks, and/or 3) a microlesion effect due to placement of the lead. This research seeks to identify how DBS-induced changes in neural connectivity contribute to cognitive decline and how brain microstructure influences these changes. Understanding how these factors has the potential to improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.
- Conditions
- Deep Brain Stimulation, Parkinson Disease
- Being tested
- DBS combined with fMRI
- Keywords
- Brain, Parkinsons, deep brain stimulation, Cognitive
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS combined with fMRIOther
Participants will undergo fMRI scanning while their DBS device is either turned OFF or ON. BOLD (blood oxygen level dependent) changes in response to DBS will be evaluated across PD participants. These scans and DBS procedure will be used for research purposes only and are not for treatment or diagnostic purposes.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's Disease undergoing DBS | Not described Receives: Other: DBS combined with fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in executive function performance
Cognitive domains known to be affected by subthalamic deep brain stimulation (STN-DBS) will be evaluated using a standardized neuropsycholoical battery. A composite measure of tests within the executive function domain (task-switching, verbal fluency, and inhibitory control) will be assessed as the primary outcome measure for behavior.
Measured: Baseline and approximately 1 year (10-14 months) following deep brain stimulation
Secondary outcomes (1)
Change in Language and Attention
Cognitive domains known to be affected by subthalamic deep brain stimulation (STN-DBS) will be evaluated using a standardized neuropsycholoical battery. A composite measure of tests within the language and attention domains will be assessed as secondary outcome measure for behavior.
Measured: Baseline and approximately 1 year (10-14 months) following deep brain stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start21 Aug 2025
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Daniel Lench, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960096
- Sponsor's protocol ID
- Pro00142451
- Other IDs
- 1K99NS131447-01, 4R00NS131447-03
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2025
- Last updated
- 8 Oct 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neural Basis for Cognitive Decline Following Deep Brain Stimulation: A DBS-fMRI Study
- ClinicalTrials.gov ID
- NCT06960096
- Acronym / sponsor ID
- Pro00142451
- Conditions
- Deep Brain Stimulation, Parkinson Disease
- Keywords
- Brain, Parkinsons, deep brain stimulation, Cognitive
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 7 May 2025 (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 objective of this research study is to understand how Deep Brain Stimulation (DBS) targeting the subthalamic nucleus (STN) affects cognitive networks in the brain, potentially leading to cognitive decline in patients with Parkinson's Disease (PD). A total of 55 participants with PD who have undergone DBS surgery will be recruited from MUSC's Clinical DBS Program. Participants will attend two post-DBS visits: a 3-hour visit for consent, demographic, and cognitive assessments, and a 3-hour DBS-MRI visit to evaluate brain network connectivity with stimulation ON and OFF. These findings will help improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.
Detailed description
Deep brain stimulation (DBS) targeting the subthalamic nucleus (STN) is a well-established surgical intervention to treat Parkinson's Disease (PD) patients with disabling motor fluctuations and dyskinesias. Although this therapy is effective for motor complications, a subset of patients will go on to experience cognitive decline, which can overshadow improvements in the quality of life provided by STN-DBS. This accelerated decline in cognition occurs in patients despite rigorous evaluation of their neuropsychological status prior to surgery. While the factors contributing to cognitive decline following DBS remain unclear, there is evidence this may be the result of 1) limited cognitive reserve prior to DBS surgery, 2) stimulation that interferes with cognitive networks, and/or 3) a microlesion effect due to placement of the lead. This research seeks to identify how DBS-induced changes in neural connectivity contribute to cognitive decline and how brain microstructure influences these changes. Understanding how these factors has the potential to improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's Disease undergoing DBS | – | Other: DBS combined with fMRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll individuals with Parkinson's disease who are undergoing clinically indicated subthalamic nucleus deep brain stimulation (STN-DBS). Participants will complete pre-operative neuroimaging using diffusion and structural MRI sequences, as well as standardized neurocognitive assessments. One year following DBS, participants will complete a follow-up cognitive evaluation. The goal is to identify brain microstructural features that predict cognitive decline after DBS.
Key inclusion criteria (2 listed)
- Subjects above 18 years of age
- Individuals with a PD diagnosis as defined by the UK Brain Bank diagnostic criteria for Parkinson's disease (58) which have undergone a neurological and neuropsychological evaluation at MUSCs movement disorder center, and were selected to undergo 3T compatible unilateral or bilateral STN- DBS implants
Key exclusion criteria (6 listed)
- Uncorrected visual or hearing impairments, as indicated by self-report
- Individuals who are pregnant or expect to become pregnant during the course of the study
- Individuals that have a history of neurological disease (other than PD) including previous stroke, major head trauma, and epilepsy or seizures.
- Individuals with claustrophobia, or the inability to lie supine position in the MRI scanner
- COPD with oxygen dependence
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 |
|---|---|---|
| DBS combined with fMRIParticipants will undergo fMRI scanning while their DBS device is either turned OFF or ON. BOLD (blood oxygen level dependent) changes in response to DBS will be evaluated across PD participants. These scans and DBS procedure will be used for research purposes only and are not for treatment or diagnostic purposes. | Other | Patients with Parkinson's Disease undergoing DBS |
Primary outcome
Change in executive function performance
Time frame: Baseline and approximately 1 year (10-14 months) following deep brain stimulation
Cognitive domains known to be affected by subthalamic deep brain stimulation (STN-DBS) will be evaluated using a standardized neuropsycholoical battery. A composite measure of tests within the executive function domain (task-switching, verbal fluency, and inhibitory control) will be assessed as the primary outcome measure for behavior.
1 secondary outcome
Change in Language and Attention
Time frame: Baseline and approximately 1 year (10-14 months) following deep brain stimulation
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 8 Oct 2026.
- Individual participant dataSharing planned: No
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Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
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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.
Daniel Lench, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Brain Stimulation and Parkinson Disease, run by Medical University of South Carolina 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 2 inclusion and 6 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 8 Oct 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 Recruitment Coordinator (843-792-0235, malakout@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in executive function performance (time frame: Baseline and approximately 1 year (10-14 months) following deep brain stimulation). 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 8 Oct 2026.