Clinical trial NCT05968703: Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease
Official title: Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Mild Cognitive Impairment
Keywords: deep brain stimulation
cognition
DBS
parkinson's disease
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2023-08-01
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will receive the interventional treatment. Two different surgical trajectories will be used for placing the leads in the NBM. Half the cohort will be randomized to each trajectory.
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Adverse Events
timeFrame: From baseline to 1 year into treatment
measure: Swing Time Coefficient of Variation
timeFrame: From baseline to 1 year into treatment
Secondary outcomes:
measure: Percent Time Freezing
timeFrame: From baseline to 1 year into treatment
measure: Stride Time Coefficient of Variation
timeFrame: From baseline to 1 year into treatment
measure: Shank Angular Velocity
timeFrame: From baseline to 1 year into treatment
measure: Tapping Speed
timeFrame: From baseline to 1 year into treatment
measure: Tapping Rhythmicity
timeFrame: From baseline to 1 year into treatment
measure: MDS-UPDRS III Score
timeFrame: From baseline to 1 year into treatment
measure: SAT Score
timeFrame: From baseline to 1 year into treatment
measure: Percent False Positives
timeFrame: From baseline to 1 year into treatment
measure: Percent Misses
timeFrame: From baseline to 1 year into treatment
measure: Average + standard deviation of response time
timeFrame: From baseline to 1 year into treatment
measure: Goal-directed focus of attention
timeFrame: From baseline to 1 year into treatment
measure: Sustained attention
timeFrame: From baseline to 1 year into treatment
measure: Distractibility
timeFrame: From baseline to 1 year into treatment
measure: Parkinson's Disease - Cognitive Rating Scale (PD-CRS)
timeFrame: From baseline to 1 year into treatment
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: From baseline to 1 year into treatment
measure: Trails A
timeFrame: From baseline to 1 year into treatment
measure: Trails B
timeFrame: From baseline to 1 year into treatment
measure: Symbol Digit Modalities (SDMT) Oral and Written
timeFrame: From baseline to 1 year into treatment
measure: visual puzzles from the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
timeFrame: From baseline to 1 year into treatment
measure: Judgement of Line Orientation
timeFrame: From baseline to 1 year into treatment
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: From baseline to 1 year into treatment
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: From baseline to 1 year into treatment
measure: MDS-UPDRS I
timeFrame: From baseline to 1 year into treatment
measure: MDS-UPDRS II
timeFrame: From baseline to 1 year into treatment
measure: MDS-UPDRS IV
timeFrame: From baseline to 1 year into treatment
measure: Neuropsychiatric Inventory (NPI)
timeFrame: From baseline to 1 year into treatment
measure: Parkinson's Disease Questionnaire-39 (PDQ-39)
timeFrame: From baseline to 1 year into treatment
measure: Caregiver Burden Assessment
timeFrame: From baseline to 1 year into treatment
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Neuroscience Health Center
state: California
Study officials:
affiliation: Stanford University
name: Helen M Bronte-Stewart, MD MSE
role: PRINCIPAL_INVESTIGATOR
References: