Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease
Recruiting · NCT05968703 · Interventional (participants receive a specific treatment) · Lead sponsor: Helen M. Bronte-Stewart
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Stanford Neuroscience Health Center - Stanford, California, United States