STN+NBM DBS for Mild Cognitive Impairment in Parkinson's Disease
Trial Summary
Will I have to stop taking my current medications?
The trial requires participants to be willing to stop their current medications when necessary for research visits.
What data supports the effectiveness of the treatment Combined STN+NBM DBS for Mild Cognitive Impairment in Parkinson's Disease?
Research shows that subthalamic nucleus deep brain stimulation (STN-DBS) can improve motor functions in Parkinson's patients, even those with mild cognitive impairment. Additionally, unintentional stimulation of the nucleus basalis of Meynert (NBM) did not lead to faster cognitive decline, suggesting potential safety and effectiveness of NBM-DBS in cognitive aspects.12345
Is STN+NBM DBS safe for humans?
Subthalamic deep brain stimulation (STN-DBS) has been used in Parkinson's disease patients and is generally considered safe, but it can lead to cognitive decline in some cases, especially in older patients or those with mild cognitive impairment. Some patients may experience serious psychiatric side effects or develop dementia over time.13467
How is the STN+NBM DBS treatment different from other treatments for mild cognitive impairment in Parkinson's disease?
The STN+NBM DBS treatment is unique because it combines deep brain stimulation (DBS) of both the subthalamic nucleus (STN) and the nucleus basalis of Meynert (NBM), targeting both motor and cognitive symptoms in Parkinson's disease with mild cognitive impairment. This dual-target approach is novel compared to traditional treatments that typically focus on either motor or cognitive symptoms separately.23489
What is the purpose of this trial?
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.
Research Team
Helen M Bronte-Stewart, MD MSE
Principal Investigator
Stanford University
Eligibility Criteria
This trial is for individuals with Parkinson's disease who have mild cognitive impairment. They must be willing to adjust their medication for research visits, able to consent, approved for STN DBS surgery, and can walk 100 feet without help. It excludes pregnant individuals, those with unstable conditions or significant depression, dementia, a history of seizures, or the need for MRI.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Treatment
Participants undergo surgery for the placement of DBS leads in the STN and NBM, followed by initial treatment with novel stimulation patterns
Treatment and Monitoring
Participants receive ongoing DBS therapy with assessments at baseline and every six months, including neuropsychological evaluations, cognitive assessments, motor tasks, and questionnaires
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Combined STN+NBM DBS
Find a Clinic Near You
Who Is Running the Clinical Trial?
Helen M. Bronte-Stewart
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator