NCT05968703 Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease
| NCT ID | NCT05968703 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Helen M. Bronte-Stewart |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2025-04-08 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM) to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The main question it aims to answer is: 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Helen M Bronte-Stewart, MD MSE
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT05968703 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 80 Years, studying Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05968703 currently recruiting?
Yes, NCT05968703 is actively recruiting participants. Contact the research team at bronte-stewart-lab@stanford.edu for enrollment information.
Where is the NCT05968703 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT05968703 clinical trial?
NCT05968703 is sponsored by Helen M. Bronte-Stewart. The principal investigator is Helen M Bronte-Stewart, MD MSE at Stanford University. The trial plans to enroll 10 participants.
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