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Combined STN and NBM Deep Brain Stimulation for Parkinson's Disease with Mild Cognitive Impairment

This study is looking at a new way to use deep brain stimulation (DBS) for people with Parkinson's disease who also have mild cognitive impairment (problems with memory or thinking). The treatment involves placing four small wires in two specific areas of the brain: the Subthalamic Nucleus (STN) and the Nucleus Basalis of Meynert (NBM). Researchers want to see if this combined STN+NBM DBS is safe and tolerable, and if it can help with thinking and movement problems. They plan to enroll 10 participants. To join, you must have Parkinson's disease, be approved for STN DBS, and be willing to temporarily stop your Parkinson's medications for research visits. You cannot have dementia or unstable medical or mental health conditions.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 participants to evaluate the safety and tolerability of the intervention.
What's involved
Participants will undergo a modified deep brain stimulation procedure. They will also need to temporarily stop their Parkinson's medications for research visits.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of the study until one year into treatment to monitor for adverse events and changes in walking ability.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05968703

Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease

Recruiting
NAAges 21–80InterventionalTreatment
Helen M. Bronte-Stewart
~10 participants
Updated 2025-05-30 on ClinicalTrials.gov
What's tested:Combined STN+NBM DBS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events
Measured over From baseline to 1 year into treatment
+1 more outcome measured

Conditions

Parkinson's Disease
Mild Cognitive Impairment

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Mild cognitive disorderParkinson Disease

NCT05968703

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Stanford Neuroscience Health Center

    Stanford, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Helen M Bronte-Stewart, MD MSE · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Study Coordinator
[email protected]
650-723-6709
Email the study team

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Eligibility criteria

Inclusion

Diagnosis of Parkinson's disease (PD)
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

Dementia
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

What this trial measures

  • Adverse EventsFrom baseline to 1 year into treatment

    Any untoward medical occurrence that occurs during this study whether or not considered related to the study device, study procedures, or study requirements that is identified or worsens during the duration of the study

  • Swing Time Coefficient of VariationFrom baseline to 1 year into treatment

    Swing time variability will be measured using the dual force plates in the SIP task and IMUs for TBC. It is defined as the mean swing time coefficient of variation (CV) of both legs.