Parkinson DiseaseNCT05822388
Cognitive Decline Following Deep Brain Stimulation
An observational study of Parkinson Disease and Movement Disorders, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This research study aims to identify MRI-based brain biomarkers that predict an individual's response to Deep Brain Stimulation (DBS). In particular, this study will focus on changes in cognition associated with DBS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Movement Disorders
- What is being tested?
- Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 31 Mar 2027
- 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: Patients with Parkinson's disease (PD) participants who will undergo DBS surgery and healthy controls.
Who may be able to join
- Subjects above 18 years of age
- Subjects who will undergo DBS surgery as part of their clinical care for PD
- Subjects above 18 years of age
- Age matched to participants in PD group
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 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.)
- Non-PD Control Participants
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- Diagnosis of Parkinsons Disease or other movement disorder
- Untreated neuropsychiatric disorders
- 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 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
This research study aims to identify MRI-based brain biomarkers that predict an individual's response to Deep Brain Stimulation (DBS). In particular, this study will focus on changes in cognition associated with DBS. A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSCs Clinical DBS Program. Participants will undergo four visits, including a 1-hour screening visit, a 1.5-hour pre-DBS MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.
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. Understanding how these factors contribute to DBS-induced cognitive decline has the potential to improve patient selection for surgery and optimize the selection of stimulation targets that minimize undesirable cognitive side effects.
- Conditions
- Parkinson Disease, Movement Disorders
- Being tested
- Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care
- Medical subject headings
- Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical CareProcedure or surgery
Participants in this study will already be undergoing a DBS intervention, however, this is part of their standard clinical care. Pre-surgical DBS candidates that enroll in this study will consent to participate in 1) pre-operative neuroimaging including a high-resolution MRI scan, 2) collection of pre-operative neurocognitive data via chart review and 3) a 1-year postoperative neurocognitive assessment.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease undergoing DBS | This study will recruit 55 patients with Parkinson's disease (PD) participants who will undergo DBS surgery and and are scheduled for a pre-DBS neuropsychological evaluation at MUSC. Receives: Procedure: Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical Care | |
| Healthy Control participants without Parkinson's Disease | This study will recruit 25 healthy controls (age-matched) to serve as a comparison of baseline cognitive and neuroimaging measures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognition
Change in cognitive performance using a comprehensive neuropsychological battery (e.g., language, executive control, memory, and attention)
Measured: From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery
Brain Microstructure (DKI)
Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion kurtosis imaging (mean kurtosis; MK)
Measured: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Secondary outcomes (2)
Brain Functional Connectivity
Functional connectivity in cognitive networks including the Nucleus Basalis of Meynert (NBM) and the striatum
Measured: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Brain Microstructure (DTI)
Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion tensor imaging (mean diffusivity; MD)
Measured: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel H Lench, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822388
- Sponsor's protocol ID
- Pro00125181
- Status last verified
- May 2026
- First submitted
- 10 Apr 2023
- Last updated
- 29 May 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 29 May 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
- ClinicalTrials.gov ID
- NCT05822388
- Acronym / sponsor ID
- Pro00125181
- Conditions
- Parkinson Disease, Movement Disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Apr 2023 (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 research study aims to identify MRI-based brain biomarkers that predict an individual's response to Deep Brain Stimulation (DBS). In particular, this study will focus on changes in cognition associated with DBS. A total of 55 participants with Parkinson's Disease planning to undergo DBS will be recruited from MUSCs Clinical DBS Program. Participants will undergo four visits, including a 1-hour screening visit, a 1.5-hour pre-DBS MRI scanning visit, and a 3.5-hour post-DBS cognitive assessment visit. In addition control participants without Parkinson's Disease will be recruited to undergo MRI scanning and cognitive assessments.
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. Understanding how these factors contribute to DBS-induced cognitive decline 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
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease undergoing DBS | – | Procedure: Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical CareThis study will recruit 55 patients with Parkinson's disease (PD) participants who will undergo DBS surgery and and are scheduled for a pre-DBS neuropsychological evaluation at MUSC. |
| Healthy Control participants without Parkinson's Disease | – | –This study will recruit 25 healthy controls (age-matched) to serve as a comparison of baseline cognitive and neuroimaging measures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease (PD) participants who will undergo DBS surgery and healthy controls.
Key inclusion criteria (4 listed)
- Subjects above 18 years of age
- Subjects who will undergo DBS surgery as part of their clinical care for PD
- Subjects above 18 years of age
- Age matched to participants in PD group
Key exclusion criteria (13 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 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.)
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 |
|---|---|---|
| Deep Brain Stimulation Surgical Procedures as Part of Routine Clinical CareParticipants in this study will already be undergoing a DBS intervention, however, this is part of their standard clinical care. Pre-surgical DBS candidates that enroll in this study will consent to participate in 1) pre-operative neuroimaging including a high-resolution MRI scan, 2) collection of pre-operative neurocognitive data via chart review and 3) a 1-year postoperative neurocognitive assessment. | Procedure or surgery | Parkinson's Disease undergoing DBS |
Primary outcome
Change in Cognition
Time frame: From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery
Change in cognitive performance using a comprehensive neuropsychological battery (e.g., language, executive control, memory, and attention)
Brain Microstructure (DKI)
Time frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Nucleus Basalis of Meynert (NBM) and striatal microstructural integrity using diffusion kurtosis imaging (mean kurtosis; MK)
2 secondary outcomes
Brain Functional Connectivity
Time frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
Brain Microstructure (DTI)
Time frame: Within the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation (DBS))
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 29 May 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.
Daniel H 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 Parkinson Disease and Movement Disorders, 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 4 inclusion and 13 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 29 May 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 Daniel H Lench, PhD (843-792-9115, lenchd@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognition (time frame: From the DBS candidacy evaluation stage (approximately one month prior to deep brain stimulation) until 1 year post surgery). 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 29 May 2026.