Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease
NCT ID: NCT05968703
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2025-04-08
2027-07-31
Brief Summary
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Is a combined deep brain stimulation approach targeting the STN and NBM with four DBS leads safe and tolerable for cognitive and cognitive-motor symptoms in individuals with Parkinson's disease with Mild Cognitive Impairment. Ten participants are anticipated to be enrolled.
Participants will undergo a modification of the traditional STN DBS approach for motor symptoms of PD. In addition to the two leads placed within the STN, two additional leads will be placed with the NBM for treatment of cognitive and cognitive-motor symptoms. Novel stimulation patterns will be used within the NBM to target cognitive and cognitive-motor symptoms using an investigational software. Participants will be followed over two years while receiving this therapy with assessments at baseline and every six months. Assessments will include a combination of neuropsychological evaluations, cognitive assessments, motor tasks (including gait/walking), and questionnaires to evaluate the treatment. Two different surgical trajectories will be used, with half the cohort randomized to each group. This will allow comparison of the impact of surgical trajectory on the intervention.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Vertical Nuclear Trajectory
Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a vertical trajectory targeting the nucleus itself.
Combined STN+NBM DBS
This intervention is a 4-lead deep brain stimulation approach targeting the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM)
Lateral NBM Bundle Trajectory
Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a lateral trajectory targeting the lateral efferent bundle from the NBM
Combined STN+NBM DBS
This intervention is a 4-lead deep brain stimulation approach targeting the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM)
Interventions
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Combined STN+NBM DBS
This intervention is a 4-lead deep brain stimulation approach targeting the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM)
Eligibility Criteria
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Inclusion Criteria
* Approved (or planning on) for subthalamic nucleus (STN) deep brain stimulation (DBS)
* Willingness to withdraw from clinical medication regimen when necessary for research visits
* Ability to provide informed consent
Exclusion Criteria
* Unstable medical, psychiatric conditions including significant untreated depression, history of suicidal attempt, or current suicide ideation
* History of seizures
* Pregnant
* Requires MRI
* Unable to walk 100 feet without an assistive device
21 Years
80 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Helen M. Bronte-Stewart
OTHER
Responsible Party
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Helen M. Bronte-Stewart
Professor of Neurology
Principal Investigators
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Helen M Bronte-Stewart, MD MSE
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford Neuroscience Health Center
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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